{"id":10188,"date":"2018-01-15T15:46:21","date_gmt":"2018-01-15T15:46:21","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/WEB-CIOMS-Guide-to-Vaccines-Safety-Communication-Guide-2018-2.pdf"},"modified":"2018-01-15T15:46:21","modified_gmt":"2018-01-15T15:46:21","slug":"web-cioms-guide-to-vaccines-safety-communication-guide-2018-2-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/que-hacemos\/salud-publica\/web-cioms-guide-to-vaccines-safety-communication-guide-2018-2-2\/","title":{"rendered":"WEB-CIOMS Guide to Vaccines Safety Communication-Guide-2018 (2)"},"author":17,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

\"\"<\/a><\/p>\n

CIOMS Guide to
\nVaccine Safety
\nCommunication
\nReport by Topic Group 3 of the CIOMS
\nWorking Group on Vaccine Safety
\nCouncil for International Organizations of
\nMedical Sciences (CIOMS)
\nGeneva, Switzerland 2018
\nGeneva 2014
\nCIOMS Guide to
\nVaccine Safety
\nCommunication
\nReport by Topic Group 3 of the CIOMS
\nWorking Group on Vaccine Safety
\nCouncil for International Organizations of
\nMedical Sciences (CIOMS)
\nGeneva, Switzerland 2018
\nCopyright \u00a9 2018 by the Council for International Organizations of Medical Sciences (CIOMS)
\nISBN: 978-92-9036091-9
\nAll rights reserved. CIOMS publications may be obtained directly from CIOMS using its website
\ne-shop module at https:\/\/cioms.ch\/shop\/. Further information can be obtained from CIOMS P.O.
\nBox 2100, CH-1211 Geneva 2, Switzerland, tel.: +41 22 791 6497, www.cioms.ch,
\ne-mail: info@cioms.ch.
\nCIOMS publications are also available through the World Health Organization, WHO Press,
\n20 Avenue Appia, CH-1211 Geneva 27, Switzerland.
\nCitations:
\nCIOMS Guide to vaccine safety communication. Report by topic group 3 of the CIOMS Working
\nGroup on Vaccine Safety. Geneva, Switzerland: Council for International Organizations of Medical
\nSciences (CIOMS), 2018.
\nNote on style:
\nThis publication uses the World Health Organization\u2019s WHO style guide, 2nd Edition, 2013 (WHO\/
\nKMS\/WHP\/13.1) wherever possible for spelling, punctuation, terminology and formatting which
\ncombines British and American English conventions.
\nDisclaimer:
\nThe authors alone are responsible for the views expressed in this publication and those views
\ndo not necessarily represent the decisions, policies or views of their respective institutions or
\ncompanies.
\nDesign and Layout: Paprika (Annecy, France)
\nACKNOWLEDGEMENTS
\nThe Council for International Organizations of Medical Sciences (CIOMS) gratefully acknowledges
\nthe contributions of the members of the CIOMS Working Group on Vaccine Safety (WG) who served
\nin the topic group 3 that produced this Guide to Vaccine Safety Communication. Generous support
\nfrom medicines regulatory authorities, industry, academia and other organizations and institutions
\nprovided experts and resources that facilitated the work culminating in this publication.
\nEach WG member and consulted reviewer participated according to their abilities and time demands
\nas actively as they were able in the meetings and discussions, teleconference calls, email exchanges,
\ndrafting and redrafting of texts and their review, which enabled the WG and topic groups to bring
\nthe project to a successful conclusion. During the multiyear process, new members from some
\norganizations were invited, in capacity of their expertise, to cover changes in assignments.
\nDuring the course of its work, topic group 3 evolved in its focus. Its genesis occurred at the first
\nWG meeting in London when vaccine crisis management arose as an area needing greater public-
\nprivate interaction, with Felix Arellano serving as topic group leader initially. Within the first year,
\nhis professional affiliation changed and he had to pass the baton. Ken Hartigan-Go accepted CIOMS\u2019s
\nrequest to assume leadership for the topic group, broadening its scope. Following his subsequent
\norganizational move, he passed on the lead role to Priya Bahri, who was invited by CIOMS to take
\ncharge of the topic group. Under Dr. Bahri\u2019s leadership, the topic group forged a new direction
\nincluding additional member input and expanded stakeholder consultation.
\nPrimary credit for the development, research, writing, and publication of this document goes to Priya
\nBahri as Editor of the Guide to Vaccine Safety Communication. CIOMS would also like acknowledge
\nthe European Medicines Agency for generously making Dr. Bahri\u2019s time available. Dr. Bahri\u2019s vision
\nfocused the topic group and through her expertise and diligent collaboration process, she brought
\nthe current Guide to fruition. Additionally, the advice and support from Patrick Zuber who heads
\nWHO Vaccine Safety and his staff was invaluable. Karin Holm acted as the CIOMS In-House Editor
\nthroughout the process.
\nCIOMS appreciates the additional members of the WG who contributed at various times on the
\ndevelopment and output of this topic group: Siti Asfijah Abdoellah, Novilia Bachtiar, Ulf Bergman,
\nRebecca Chandler, Peter Glen Chua, Mimi Delese Darko, Alexander Dodoo, Ken Hartigan-Go, Marie
\nLindquist, and Paulo Santos. Outside expertise is gratefully acknowledged from Bruce Hugman,
\nKatrine Bach Habersaat, and Madhav Ram Balakrishnan.
\nDuring the public consultation via the CIOMS website from 28 August to 11 October 2017, comments
\nwere received from experienced institutions, namely the National Institute for Public Health and the
\nEnvironment of the Netherlands, the Center of Biologics Evaluation and Research (CBER) at the US
\nFood and Drug Administration and the World Medical Association (WMA) (see Annex 3). In addition,
\nHeidi Larson from the London School of Hygiene and Tropical Medicine and Robert Pless from Health
\nCanada, commented as individual experts. Their comments were welcoming and supportive to the
\nreport, and clarifications on the recommendations and updates to some of the references, as well
\nas additions to the reading list have been implemented in to the final report in response to the
\ncomments. Unless indicated otherwise the comments from external reviewers were considered as
\nexpert, personal opinions and not necessarily representing those of their employers or affiliations.
\nCIOMS thanks those who have commented for their time and support.
\nGeneva, Switzerland, December 2017
\nLembit R\u00e4go, MD, PhD
\nSecretary-General, CIOMS
\niii
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nCONTENTS
\nACKNOWLEDGEMENTS\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd III
\nFOREWORD\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd VIII
\nACRONYMS AND ABBREVIATIONS\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffdIX
\nREADER\u2019S GUIDE\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffdX
\nCHAPTER 1. INTRODUCTION\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd1
\nCHAPTER 2. CONSIDERATIONS FOR VACCINE SAFETY COMMUNICATION\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd7
\n2.1.
\nAudiences and aims of vaccine safety communication………………………………………………………………. 7
\nFigure 2.1: The social-ecological model (SEM)…………………………………………………………………………8
\n2.2.
\nCommunicating evidence and uncertainties for informed decision-making……………………………………… 9
\nGuidance Summary 2.2: Addressing uncertainty in vaccine safety………………………………………………10
\n2.3.
\nTransparency for honest communication and public trust-building………………………………………………. 11
\nGuidance Summary 2.3: Building trust in vaccine safety………………………………………………………….. 11
\nExample 2.3: Re-building trust in the MMR vaccine in the United Kingdom…………………………………….12
\n2.4.
\nPerceptions of risk as a trigger of vaccine hesitancy……………………………………………………………….15
\nFigure 2.4: The WHO Strategic Advisory Group of Experts (SAGE) on Immunization Model of
\ndeterminants of vaccine hesitancy ……………………………………………………………………………………..16
\nGuidance Summary 2.4: Addressing vaccine hesitancy……………………………………………………………18
\nExample 2.4.1: Overcoming hesitancy against the MMR vaccine in sub-populations in Sweden………….18
\nExample 2.4.2: The need for understanding public concerns over HPV vaccines prior to
\nlicensure and launch………………………………………………………………………………………………………..20
\nCHAPTER 3. PRODUCT LIFE-CYCLE MANAGEMENT APPROACH TO VACCINE
\nSAFETY AND COMMUNICATION\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd22
\n3.1.
\nCommunication as part of vaccine pharmacovigilance……………………………………………………………..22
\n3.2. Pre-licensure and launch phase…………………………………………………………………………………………..23
\nExample 3.2.1: The need for understanding concerns in different communities over the Ebola
\nvirus and vaccines prior to launching clinical trials…………………………………………………………………..23
\nGuidance Summary 3.2.1: Concept of risk management systems for medicinal products………………..25
\nFigure 3.2: Risk management cycle…………………………………………………………………………………….25
\nGuidance Summary 3.2.2: Types of risk minimization measures for medicinal products…………………..26
\nExample 3.2.2: Risk management planning for DTPw-HBV quadrivalent vaccine……………………………..26
\nExample 3.2.3: The introduction of pentavalent vaccines in Kerala, India, supported by close
\ninteractions with the healthcare community and the media ………………………………………………………. 27
\n3.3. Post-licensure phase………………………………………………………………………………………………………..28
\nExample 3.3.1: Addressing the risk of febrile seizures with a serogroup
\nB\u00a0meningococcal\u00a0vaccines in the United Kingdom…………………………………………………………………..29
\nExample 3.3.2: Addressing the safety concern of narcolepsy for the H1N1 pandemic influenza
\nvaccine used in Sweden…………………………………………………………………………………………………… 31
\nCHAPTER 4. VACCINE SAFETY COMMUNICATION PLANS (VACSCPS)\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd33
\n4.1.
\nApplication of a strategic communication approach to vaccine safety………………………………………….33
\nFigure 4.1: The P-Process of strategic health communication……………………………………………………33
\nChecklist 4.1: Management considerations for VacSCPs………………………………………………………….34
\n4.2.
\nDeveloping VacSCPs on the basis of a model template……………………………………………………………35
\nTemplate 4.2: Template for strategic vaccine type- and situation-specific vaccine safety
\ncommunication plans (VacSCPs)…………………………………………………………………………………………36
\nGuidance Summary 4.2: Developing communication strategies on vaccine benefits and risks………….. 37
\n4.3. Monitoring, evaluating and maintaining VacSCPs…………………………………………………………………….38
\n4.3.1
\nMonitoring of debates and sentiments in communities and the public…………………………………..39
\nExample 4.3.1: Social media monitoring during polio supplementary immunization activities (SIA)
\nin Israel………………………………………………………………………………………………………………………..40
\nExample 4.3.2: Utility of online news media monitoring for prepared communicating of the
\noutcome of a safety assessment for HPV vaccines at the European Medicines Agency (EMA)……………40
\nCHAPTER 5. VACCINE SAFETY COMMUNICATION SYSTEMS\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd42
\n5.1.
\nFunctions of vaccine safety communication systems……………………………………………………………….42
\nChecklist 5.1: Key functions of vaccine safety communication systems……………………………………….42
\n5.2. Multistakeholder network………………………………………………………………………………………………….42
\nTable 5.2.1: Main stakeholders involved in the vaccine safety communication process ……………………43
\nChecklist 5.2: Establishing and maintaining national stakeholder networks……………………………………43
\nTable 5.2.2: Purposes of multistakeholder interactions ……………………………………………………………44
\nExample 5.2: Managing an adverse event following immunization with HPV vaccine in the United
\nKingdom ………………………………………………………………………………………………………………………45
\n5.3.
\nRegional and international awareness and collaboration……………………………………………………………50
\nFigure 5.3: Relationships of parties in global vaccine safety………………………………………………………50
\nCHAPTER 6. CAPACITY BUILDING FOR VACCINE SAFETY COMMUNICATION SYSTEMS52
\n6.1. Skills and capacity requirements………………………………………………………………………………………..52
\nChecklist 6.1: Skills and capacity requirements for vaccine safety communication………………………….52
\n6.2. Contents and objectives of training……………………………………………………………………………………..53
\nTable 6.2: Curriculum for vaccine safety communication…………………………………………………………..53
\nExample 6.2.1: Training programme on vaccine safety communication by the WHO Regional
\nOffice for Europe (WHO-EURO)……………………………………………………………………………………………54
\nExample 6.2.2: Training resources of the Network for Education and Support in Immunisation (NESI)…54
\n6.3. Comprehensive approach to capacity building……………………………………………………………………….55
\nANNEX 1: READING LIST\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd56
\nANNEX 2: CONTRIBUTION TO THE CIOMS GUIDE TO ACTIVE VACCINE SAFETY
\nSURVEILLANCE\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd 61
\nANNEX 3: MEMBERSHIP, EXTERNAL REVIEWERS, AND MEETINGS\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd63
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nv
\nLevel 1: CIOMS Summaries
\nTable 5.2.1: Main stakeholders involved in the vaccine safety communication process ………….43
\nTable 5.2.2: Purposes of multistakeholder interactions ……………………………………………………….44
\nTable 6.2: Curriculum for vaccine safety communication………………………………………………………53
\nChecklist 4.1: Management considerations for VacSCPs\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd34
\nChecklist 5.1: Key functions of vaccine safety communication systems\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd42
\nChecklist 5.2: Establishing and maintaining national stakeholder networks\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd43
\nChecklist 6.1: Skills and capacity requirements for vaccine safety communication\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd52
\nTemplate 4.2:
\nTemplate for strategic vaccine type- and situation-specific vaccine safety
\ncommunication plans (VacSCPs)\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd36
\nLevel 2: Guidance Summaries
\nGuidance Summary 2.2: Addressing uncertainty in vaccine safety\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd10
\nGuidance Summary 2.3: Building trust in vaccine safety\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd11
\nGuidance Summary 2.4: Addressing vaccine hesitancy\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd18
\nGuidance Summary 3.2.1: Concept of risk management systems for medicinal products\ufffd\ufffd\ufffd\ufffd\ufffd25
\nGuidance Summary 3.2.2: Types of risk minimization measures for medicinal products\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd26
\nGuidance Summary 4.2: Developing communication strategies on vaccine benefits and risks
\n37
\nSUMMARIES & EXAMPLES
\nLegend:
\nf
\nf CIOMS summaries with key references in Tables grey, Checklists red, and a Template in yellow
\n(LEVEL 1)
\nf
\nf Guidance Summaries of existing practical guidance documents with precise (linked) references
\nblue and multicoloured Figures (LEVEL 2)
\nf
\nf Examples from real-world with references to source green (LEVEL 3)
\nvi
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nLevel 3: Examples
\nExample 2.3: Re-building trust in the MMR vaccine in the United Kingdom\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd12
\nExample 2.4.1: Overcoming hesitancy against the MMR vaccine in sub-populations in Sweden18
\nExample 2.4.2:
\nThe need for understanding public concerns over HPV vaccines prior to
\nlicensure and launch\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd20
\nExample 3.2.1:
\nThe need for understanding concerns in different communities over the
\nEbola virus and vaccines prior to launching clinical trials\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd23
\nExample 3.2.2: Risk management planning for DTPw-HBV quadrivalent vaccine\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd26
\nExample 3.2.3:
\nThe introduction of pentavalent vaccines in Kerala, India, supported by
\nclose interactions with the healthcare community and the media \ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd27
\nExample 3.3.1:
\nAddressing the risk of febrile seizures with a serogroup
\nB\u00a0meningococcal\u00a0vaccines in the United Kingdom\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd29
\nExample 3.3.2:
\nAddressing the safety concern of narcolepsy for the H1N1 pandemic
\ninfluenza vaccine used in Sweden\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd31
\nExample 4.3.1:
\nSocial media monitoring during polio supplementary immunization
\nactivities (SIA) in Israel\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd40
\nExample 4.3.2:
\nUtility of online news media monitoring for prepared communicating of
\nthe outcome of a safety assessment for HPV vaccines at the European
\nMedicines Agency (EMA)\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd40
\nExample 5.2:
\nManaging an adverse event following immunization with HPV vaccine in
\nthe United Kingdom \ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd45
\nExample 6.2.1:
\nTraining programme on vaccine safety communication by the WHO
\nRegional Office for Europe (WHO-EURO)\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd54
\nExample 6.2.2:
\nTraining resources of the Network for Education and Support in
\nImmunisation (NESI)\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd\ufffd54
\nFigures
\nFigure 2.1: The social-ecological model (SEM)……………………………………………………………………… 8
\nFigure 2.4:
\nThe WHO Strategic Advisory Group of Experts (SAGE) on Immunization Model
\nof determinants of vaccine hesitancy ……………………………………………………………….16
\nFigure 3.2: Risk management cycle……………………………………………………………………………………25
\nFigure 4.1: The P-Process of strategic health communication………………………………………………33
\nFigure 5.3: Relationships of parties in global vaccine safety…………………………………………………50
\nvii
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nFOREWORD
\nSince its inception in 1949 by the World Health Organization and UNESCO, the Council for International
\nOrganizations of Medical Sciences (CIOMS) has contributed in various roles by taking up scientific
\ntopics benefiting from collaboration across the sectors of public health agencies, medicines regulatory
\nor competent authorities, the pharmaceutical industry, and academia. Over the years CIOMS has
\nevolved into an independent, non-governmental international organization that provides a neutral
\nand objective forum conducive to public-private interaction on issues concerning medical sciences,
\nmost recently focused around pharmacovigilance and bioethics.
\nIn 2013 a new working group was formed, the CIOMS Working Group on Vaccine Safety (WG) to
\naddress unmet needs in the area of vaccine pharmacovigilance and specifically address Objective
\n#8 of WHO\u2019s Global Vaccine Safety Initiative regarding public-private information exchange. The WG\u2019s
\nreport issued at the beginning of 2017, CIOMS Guide to Active Vaccine Safety Surveillance (Guide
\nAVSS)1, offers a practical step-by-step approach and a graphic algorithm to aid immunization
\nprofessionals and decision-makers in determining the best course of action when confronting such
\nchallenges. The Guide AVSS provides a structured process, a checklist for evaluating the extent of
\ndata resources, and several case studies for review.
\nThis current CIOMS Guide to Vaccine Safety Communication (Guide or report) stemmed from
\ntopic group 3 of the WG which brought together, in a unique forum, pharmacovigilance specialists
\nand other experts from regulatory and public health authorities, the World Health Organization,
\nand academia as well as manufacturers in emerging and industrialized countries. The Guide presents
\nrecommendations for vaccine safety communication with a specific focus on regulatory bodies.
\nA number of communication guidance documents already exist for immunization programmes
\ncovering how to manage communication when an adverse event occurs. Few have thus far been
\nissued addressing the specific needs of regulatory bodies or competent authorities \u2014 whether
\nthey be established authorities in high-income countries or developing authorities in resource-limited
\ncountries. Little has been published for these groups in relation to communication about risks,
\nuncertainties, safety and safe use of the vaccine products they license.
\nThis CIOMS report aims to fill this gap. Although the Guide sources from existing guidance documents,
\nit compiles recommendations relevant from a regulatory perspective and creates a common ground
\nin a way that has not been achieved otherwise at global level. The Guide stresses the fundamental
\nimportance of regulatory bodies having a system in place with skilled persons who can efficiently
\nrun vaccine safety communication in collaboration with stakeholders.
\n1\t Council for International Organizations of Medical Sciences (CIOMS). CIOMS Guide to Active Vaccine Safety Surveillance (report of
\nthe CIOMS Working Group on Vaccine Safety). Geneva: CIOMS, 2017.
\nviii
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nACRONYMS AND ABBREVIATIONS
\nAEFI
\nAVSS
\nCIOMS
\nECDC
\nEMA
\nGACVS
\nGVSI
\nH1N1
\nHCP
\nHPV
\nKAP
\nMMR
\nNGO
\nNIP
\nNRA
\nPV
\nRLC
\nSAGE
\nSEM
\nSIA
\nTIP
\nUMC
\nUNICEF
\nUSFDA
\nVacSCP
\nVSC
\nVSN
\nWHO
\nAdverse event following immunization
\nActive vaccine safety surveillance
\nCouncil for International Organizations of Medical Sciences
\nEuropean Centre for Disease Prevention and Control
\nEuropean Medicines Agency
\nGlobal Advisory Committee on Vaccine Safety
\nGlobal Vaccine Safety Initiative
\nA pandemic flu strain
\nHealthcare professionals
\nHuman papillomavirus
\nKnowledge, attitudes, practices
\nMeasles mumps rubella
\nNon-governmental organization
\nNational immunization program
\nNational regulatory authority
\nPharmacovigilance
\nResource-limited country
\nStrategic Advisory Group of Experts
\nSocial-Ecological Model
\nSupplementary immunization activity
\nTailoring Immunization Programmes
\nUppsala Monitoring Centre
\nUnited Nations Children\u2019s Fund
\nUnited States Food and Drug Administration
\nVaccine safety communication plan
\nVaccine safety communication
\nVaccine Safety Net
\nWorld Health Organization
\nix
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nREADER\u2019S GUIDE
\nThe CIOMS Guide to Vaccine Safety Communication (Guide or report) provides an overview of
\nstrategic communication issues faced by regulators, those responsible for vaccination policies and
\nprogrammes and other stakeholders involved in introducing: (1) newly-developed vaccines for the first
\ntime to market or (2) current or underutilized vaccines into new countries, regions, or populations.
\nThe Guide discusses the complexity of vaccine safety communication (see Chapter 2) and builds upon
\nalready existing expert recommendations to fill a specific niche that is meant to be particularly useful
\nto regulatory authorities in resource-limited countries (RLCs). The Guide draws upon recommendations
\nfrom numerous institutional materials for compilation of guidance, for example, on aims (see \u00a72.1),
\nkey functions (see \u00a75.1), networks (see \u00a75.2 and \u00a75.3) and capacity-building (see Chapter 6). Where
\nexisting recommendations have been summarized, this has been done in a very condensed manner.
\nThe references provided allow for returning to the source documents for more in-depth reading on
\nthe concepts and their background if required.
\nRecognizing the successful implementation of strategic communication for some objectives in other
\nareas of health, the recommendations in the Guide are based on this strategic process. However
\nthis report is not a process guide, as such processes can be adapted for the specific needs of
\nindividual regulatory bodies from general sources on health communication.
\nMore practically and immediately tangible, the Guide presents the CIOMS template of a vaccine safety
\ncommunication plan (VacSCP) to provide for proactive, prepared and responsive communication.
\nThe template allows for specific planning, monitoring and adapting of communications for each
\nvaccine type in the given local situation (see CIOMS VacSCP Template \u00a74.2). This is important as
\npublic sentiments differ locally by vaccine type, disease epidemiology and public debate.
\nAs this report supports regulatory bodies, it discusses how assessment for licensure, pharmacovigilance
\nand communication should be interactive processes within these bodies (see Chapter 3). It also
\nconsiders the context regulators have to keep awareness of – in particular tensions between evidence
\nand uncertainty, public trust and mistrust, and vaccine acceptance and vaccine hesitancy (see
\n\u00a72.2 and \u00a72.4), all subject to sudden or slow change over time. It may be most appropriate for a
\nregulatory body to build up their vaccine safety communication system and VacSCPs gradually over
\ntime in accordance with local needs.
\nThe recommendations in this report are not only based on existing guidance, but also on established
\npractices, experiences of immunization programmes and regulatory bodies as well as evidence
\nfrom relevant research. All references are provided in footnotes. Where recommendations and
\nconsiderations are not referenced, these constitute the views of the CIOMS topic group.
\nThe Guide can be read in many ways. Of course, it can be read from beginning to end to follow its
\nprimary logic – that is, from aims and context, over pharmacovigilance and communication planning,
\nto building up the necessary communication system. Readers may however use any section as
\nentry point, depending on one\u2019s background and most immediate interest. Cross-references to the
\nother sections (with hyperlinks in the digital version) are provided throughout the report allowing for
\nflexible reading. Nonetheless Chapter 1\u2019s introduction and overview will be a suitable section with
\nwhich to start upfront for all readers to understand the underlying approach of the Guide. The report
\nalso presents a number of examples of successful communication interventions around the globe
\nto illustrate the recommendations (highlighted in green). These examples can also be read first to
\nenter the report through gaining an initial practical understanding of the recommendations.
\nAn additional reading list can be found in Annex I, organized by topics, guides readers for further
\nlearning and training.
\nx
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nCHAPTER 1.
\nINTRODUCTION
\nVaccines transformed global health and continue to yield health gains in this century. Through
\nimproving health, immunization promises further benefits for individuals and societies at large,
\nincreasing earning power and saving healthcare costs. The range of vaccines and diseases they
\ncan prevent is expanding. Consequently, the need for strong safety surveillance of vaccine products
\nand clear communication to inform the public is growing as well.
\nThe World Health Organization launched the Global Vaccine Action Plan (GVAP) in 2012 for the period
\nthrough 2020.2 The GVAP is a roadmap setting targets for each vaccine-preventable disease and
\naddressing how to bestow the full benefits of immunization to all people. Important GVAP goals are
\nto add polio to the list of globally eradiated diseases (to join smallpox) and to accelerate progress
\ntowards the elimination of measles, rubella and neonatal tetanus. Priorities include the additional
\ncontrol of diseases that can be addressed through improving coverage rates of existing routine
\nimmunizations (e.g. diphtheria, Haemophilus influenzae type B (Hib), hepatitis B virus, pertussis,
\nrubella, tetanus, and tuberculosis), and the development and use of new vaccines. The Strategic
\nAdvisory Group of Experts (SAGE) on Immunization to WHO recently produced an Assessment
\nReport of GVAP and advised that post-2020, \u201cthe challenge will be to ensure that these gains are
\nprotected and further extended \u2013 to ensure more vaccines reach more people more rapidly.\u201d3 This
\ncould involve countries and stakeholders directing more resources towards:4
\n1.\t recently developed and\/or underutilized vaccines (e.g. humanpapilloma virus (HPV), pneumococcal,
\nand rotavirus);
\n2.\t vaccines intended for regionally prevalent diseases (e.g. cholera, Japanese encephalitis,
\nmeningitis A, seasonal influenza, and yellow fever); as well as
\n3.\t new vaccines in development or on the horizon (e.g. against dengue, Ebola, or Zika viruses,
\nhuman immunodeficiency virus (HIV), malaria, sexually-transmitted diseases, or an improved
\nvaccine against tuberculosis).
\nThe Council for International Organizations of Medical Sciences (CIOMS) can make an important
\ncontribution to meeting this challenge as one of its major aims is: \u201ccontributing to harmonised views
\nof international systems and terminologies used for the safety surveillance of medicinal products and
\nvaccines between stakeholders.\u201d The independent status of CIOMS has permitted the organization
\nover the decades of its existence to facilitate the collaborations and expertise of senior scientists from
\nnational medicines regulatory authorities, academia, public health agencies, representative bodies of
\nmedical specialties and research-based biopharmaceutical companies. CIOMS has convened numerous
\nworking groups on pharmacovigilance topics, including one that produced the CIOMS report on Definition
\nand Application of Terms for Vaccine Pharmacovigilance and an annex on Vaccines in the CIOMS IX
\nreport on Practical Approaches to Risk Minimisation for Medicinal Products.5
\n2\t WHO Global vaccine action plan 2011-2020
\nhttp:\/\/www.who.int\/immunization\/global_vaccine_action_plan\/GVAP_Guiding_Principles_Measures_of_Success_and_Goals.pdf?ua=1.
\n3\t 2017 Assessment Report of the Global Vaccine Action Plan Strategic Advisory Group of Experts on Immunization. Geneva: World
\nHealth Organization; 2017. Licence: CC BYNC-SA 3.0 IGO, p.28
\n4\t SAGE meeting reports available at www.who.int\/immunization\/sage\/meetings\/2017\/october\/en\/, accessed October 2017.
\n5\t CIOMS website, https:\/\/cioms.ch\/about\/
\nChapter
\n1.
\nIntroduction
\n1
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nThe Working Group\u2019s mandate, aim and addresses
\nTo continue this work, the CIOMS Working Group on Vaccine Safety (WG) was formed to support the
\nWorld Health Organization (WHO) in the implementation of the strategic objective 8 of its Blueprint
\nof the Global Vaccine Safety Initiative (GVSI)6, which is: \u201cto put in place systems for appropriate
\ninteraction between national governments, multilateral agencies7 and manufacturers at national,
\nregional and international levels\u201d particularly concerning underutilized and new vaccines expected
\nto be of global, regional or local significance in the near- to long-term.
\nThe WG divided itself into three key areas affecting vaccine safety when a newly-developed vaccine
\nor new-to-the-country vaccine is introduced into a population. Topic group1 focused on examining
\nthe safety baseline data needed by country regulatory authorities and immunization programmes
\nand contributed the Appendix I: Essential Vaccine Information (EVI) to the CIOMS Guide to Active
\nVaccine Safety Surveillance (Guide AVSS). Topic group 2 took charge of contributing the main body
\nof the Guide AVSS. Topic group 3 concentrated on the communications aspect of vaccine safety.
\nThrough the course of multistakeholder discussion and collaboration, over several meetings topic group
\n3 determined its critical value would be to create this CIOMS Guide to Vaccine Safety Communication
\n(referred to as Guide or report) which complements other helpful documents from WHO and other
\norganizations by filling a gap for regulatory needs applicable globally. The Guide additionally supports
\nthe implementation of strategic objective 3 of the GVSI Blueprint, which is \u201cto develop vaccine
\nsafety communication plans at country level, to promote awareness of vaccine risks and benefits,
\nunderstand the perception of the risk and prepare for managing any adverse events and concerns
\nabout vaccine safety promptly.\u201d Therefore this report is addressed particularly to the authorities in
\ncharge of vaccine pharmacovigilance at country level \u2013 usually the national regulatory authorities.
\nWhile this report addresses regulatory bodies and supports WHO\u2019s GVSI, the recommendations
\nare also applicable to vaccine safety communication in general. In particular, national immunization
\nprogrammes or other groups which may exist in some countries, have a major responsibility for
\nprogramme implementation and delivery, assuming an important role relative to vaccine safety and
\ncommunication. While they may have specific guidance documents available, the approach taken in this
\nreport might prove informative for them. In addition, vaccine manufacturers might learn from this report
\na new perspective about safety communication systems to improve their corporate pharmacovigilance
\nsystems and product-related communication interventions, facilitating interactions with their medical
\ninformation and public relation functions internally, and with governmental bodies externally.
\nBackground of existing guidance documents and
\napproach taken by the Working Group
\nA number of vaccine communication guides already exist (and were reviewed by the topic group),
\nbut these are often field-oriented and primarily provide for those in charge of immunization
\nprogrammes, covering in particular how to be prepared and manage communication when an
\nadverse event occurs. Some also include guidance for healthcare professionals. So far, only a few
\nregulatory bodies have issued guidance addressing the specific needs of regulators in relation to
\n6\t World Health Organization (WHO). Global Vaccine Safety Blueprint (WHO\/IVB 12.07). Geneva: WHO, 2012. Accessible at: http:\/\/
\nextranet.who.int\/iris\/restricted\/bitstream\/10665\/70919\/1\/WHO_IVB_12.07_eng.pdf?ua=1.
\n7\t Agencies formed by several countries to serve them, such as UN system and other regional and sub-regional organizations.
\nChapter
\n1.
\nIntroduction
\n2
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\ncommunicating about risks, uncertainties, safety and safe use of the vaccine products they license
\n(e.g. European Medicines Agency8).
\nEffective communication of assessment outcomes is, however, an important part of the mandate of
\nregulatory bodies and expected by the public and all stakeholders, at the time a vaccine product is
\nnewly launched in a country as well as if a concern emerges later in the product life-cycle. Although this
\nreport sources from existing guidance documents, in particular those for immunization programmes,
\nit compiles recommendations relevant from a regulatory perspective and creates a common ground
\nin a way that has not been achieved otherwise at global level.
\nThe existing guidance documents have been selected as references for their respective focus on
\ncertain elements of communication and the expertise they contain, reflecting current evidence and
\nauthority. They have mainly been issued by major organizations, like WHO and national and regional
\npublic health agencies, such as the Centers for Disease Control and Prevention (CDC) in the United
\nStates and the European Centre for Disease Prevention and Control (ECDC) in the European Union.
\nThese organizational references have been complemented by publications in scientific journals on
\nspecific aspects of communication. The recommendations in this report are also based on established
\npractices, experiences of immunization programmes and regulatory bodies, as well as evidence
\nfrom relevant research and duly cited in footnotes.
\nWhere recommendations and considerations are not referenced, these constitute the views of the
\nCIOMS topic group.
\nOverall, topic group 3 dedicated itself to issue a \u2018guide\u2019, which means to provide recommendations based
\non established principles, research evidence and example-based learning. As with recommendations for
\nany complex intervention in highly variable and continuously changing situations, the recommendations
\ncannot be specific. Therefore this Guide is intended to provide primarily to regulators, but also to
\nother relevant parties in charge of vaccination programmes on the country level, a foundation for
\nunderstanding complex communication issues related to vaccines safety. In addition, it aims to
\nprovide general recommendations on how to create vaccine safety communication plans and deliver
\nin real life situations high quality communication input messages for those actually in charge of the
\ncommunications.
\nThe strategic approach to communication
\nAs some major health objectives \u2013 for example, the prevention of infection with human immunodeficiency
\nvirus (HIV) \u2013 have been achieved with support of strategic communication, the recommendations in
\nthe current Guide are based on this strategic process. However this report is not a process guide
\ndetailing who has to do what, when, why and how, as such processes can (and should) be adapted
\nfor the specifics of individual regulatory bodies from general sources on health communication.
\n8\t European Medicines Agency (EMA) and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices \u2013 product-
\nor population-specific considerations I: vaccines for prophylaxis against infectious diseases. London: EMA, 12 December 2013.
\nAccessible at: http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/regulation\/document_listing\/document_listing_000345.
\njsp&mid=WC0b01ac058058f32c.
\nChapter
\n1.
\nIntroduction
\n3
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nThe concept of communication plans
\nMore practically and immediately tangible, this report presents the CIOMS template of a vaccine
\nsafety communication plan (VacSCP) that allows for specific planning, monitoring and adapting of
\ncommunication that is proactive, prepared and responsive.
\nTopic group 3 of the CIOMS Working Group on Vaccine Safety proposes to define vaccine safety
\ncommunication plans at country level as \u201cindividual vaccine safety communication plans that are
\nspecific to vaccine types and the local situation\u201d (VacSCPs, see Chapter 4).
\nThese VacSCPs need to be kept up-to-date in accordance with changing evidence and information on the
\nquality and safety of vaccine products and their effectiveness. VacSCPs should be periodically adapted to
\nthe context of evolving public health needs and the evolving debates at policy level and in the public domain.
\nAs regulators monitor the benefit-risk balance of the vaccines they license, they should ideally also monitor
\nthe public debate and possible rumours about vaccines in the communities and the media. For regulatory
\ncommunication to be most effective, their communication plans and messages can address concerns
\nraised by the public and fill information needs. It is understood that the individual VacSCPs may have
\ngeneric elements in common or even be part of a single planning framework at country level, or that
\nthere will be local prioritization concerning which vaccines need a communication plan.
\nIn any case, the VacSCPs are meant to focus on the safety of vaccine products as assessed by
\nthe applicable regulatory authority and do not opine on immunization policy, which falls under
\nthe responsibility of the public health authorities. The information provided by regulatory bodies
\nneeds, however, to be useful to others for making decisions on immunization programmes and
\nimmunizations of individuals. This requires listening to stakeholders as part of the communication
\nprocess, in order to understand which concerns and information needs have to be addressed by
\nregulators responsible for vaccine safety.
\nOverall, vaccine safety communication consists of complex processes of listening and messaging
\nbetween the regulatory bodies and all stakeholders, including the manufacturers responsible for
\nvaccine safety, the multiple institutional parties involved in immunization, the media, and most
\nimportantly, the communities and the people who should benefit from vaccines.
\nThe concept of a systems approach to vaccine
\nsafety communication
\nAs health and information needs are evolving, VacSCPs cannot be static plans. Therefore the topic
\ngroup has taken the view that in order to manage vaccine safety communication professionally and to
\na high quality standard, a system is needed at the level of regulatory bodies for developing, updating,
\nimplementing and evaluating these plans. Such vaccine safety communication systems should
\noperate continuously and always be designed for proactivity, preparedness and responsiveness. It is
\nrecommended to put a system in place with dedicated people and resources with defined objectives,
\nfunctions and expertise (see \u00a75.1). Capacity-building in this respect is very important (see Chapter 6).
\nThis report provides added value by presenting a \u201csystems approach\u201d with an integration of
\ncommunication as part of pharmacovigilance and risk management for vaccine products (see Chapter
\n3). In this respect, it is stressed that communication, no matter how skilful and carefully designed,
\ncannot and is not meant to disguise any lack of evidence, uncertainty or flaws in the processes of
\nsafety surveillance, risk management or regulatory decision-making. The link between communication
\nand transparency is vital (see \u00a72.3).
\nChapter
\n1.
\nIntroduction
\n4
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nIn order to understand each given situation and to design effective communication interventions, it is
\nnecessary to build relationships with representatives of all stakeholders. This requires, as part of the
\ncommunication system, establishment and maintenance of local and global stakeholder networks,
\nunderpinned by policies that prevent undue influences (see \u00a75.2 and \u00a75.3).
\nContextual considerations
\nOf course, those engaged in vaccine safety communication cannot ignore the contexts in which they
\nwork. While vaccines have been one of the most successful health interventions and vast population
\ngroups agree with immunization,9 at the same time there is a debate in the public domain around
\nvaccine benefits, risks and uncertainties, and some groups and individuals are hesitant or reject
\nvaccines, or develop mistrust in scientists and officials (see \u00a72.4) and collaborating with stakeholders
\nis therefore vital (see \u00a72.3).
\nThe systems and planning approach referenced in this Guide is considered the best way to manage
\ncommunication in the event of a public health emergency, such as a pandemic, and to prevent or
\nmanage situations of crisis, which can be triggered, for example, by a public reaction to a safety
\nconcern.
\nGlobal scope of the report
\nEstablished authorities in both high-income countries and resource-limited countries (RLCs) share
\ninterests and concerns around good communication on vaccine safety, and seek approaches for
\nimprovement. The recommendations of this report are therefore valid for any country, but specific
\nconsideration has been given to resource limitations in many countries. The components for a
\nvaccine safety communication system are presented with a view to building them up gradually,
\ntaking into account local resources, opportunities and priorities. In this way, a tailored system can
\nbe built over time.
\nGlobal sharing of examples and experience
\nExamples illustrating aspects of successful communication interventions and underpinning the
\nrecommendations are taken from different countries around the globe to demonstrate feasibility
\nand value. Some examples specifically show how they can be implemented in RLCs.
\nThe topic group deliberately did not include examples of unsuccessful communication, because
\nrarely one has all the information to judge a specific situation, and it was also not within the scope
\nof the topic group to engage with those responsible for communication in such cases for in-depth
\nreviews and lessons learnt. Preference was therefore given to positive examples of successful
\ncommunication to stay within a constructive spirit.
\n9\t \u201cImmunization\u201d as used in this report means the usage of a vaccine for the purpose of immunizing individuals. It is generally
\nacknowledged that (1) \u201cimmunization\u201d is a broader term than \u201cvaccination\u201d, including active and passive immunization, and (2)
\nimmunization when used strictly implies an immune response. In keeping with other key published literature in the field of immunization,
\nthe terms \u201cimmunization\u201d and \u201cvaccination\u201d are generally used interchangeably in the current report. (see Council for International
\nOrganizations of Medical Sciences (CIOMS). Definition and application of terms of vaccine pharmacovigilance (report of CIOMS\/WHO
\nWorking Group on Vaccine Pharmacovigilance). Geneva: CIOMS,2012). Accessible at: https:\/\/cioms.ch\/shop\/product\/definitions-
\nand-applications-of-terms-for-vaccine-pharmacovigilance\/.
\nChapter
\n1.
\nIntroduction
\n5
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nRelationship of this report with other CIOMS reports
\non vaccines
\nThis report is related to the other report of the CIOMS Working Group on Vaccine Safety, namely the CIOMS
\nGuide to Active Vaccine Safety Surveillance (Guide AVSS).10 Topic group 3 made a contribution to that
\nGuide AVSS (see Annex 2 for description), given that active safety surveillance and communication are
\nprocesses running in parallel and should be integrated via pharmacovigilance systems (see Chapter 3).
\nThis report is also related to the CIOMS Definition and Application of Terms for Vaccine Pharmacovigilance,
\nfrom where it draws the concept of vaccine pharmacovigilance and agreed terminology.11
\nIt does not include the reporting or identifying of individual adverse events following immunization
\n(AEFIs)12, which can be considered as a type of communication, but for which specific guidance exists.13
\nApplicability of this report to medicines beyond vaccines
\nWhile developing the report, reviewed documents included those not specific to vaccines, but more
\nbroadly to communication about medicinal products by regulatory bodies.14, 15, 16, 17
\nTherefore, CIOMS would like to make regulatory bodies aware that the recommendations in this
\nreport could be leveraged for use in their communication systems and processes for medicines
\nother than vaccines. The same principles, systems approach, communication plan template and
\nrelated processes proposed for vaccines could be applied and tailored to other medicinal product
\nclasses, as each class will have its specific challenges in communicating for understanding, informed
\nchoice, safe and trusted use as well as adherence. There are currently few guidance documents
\navailable for other medicinal product classes of similar content combining concepts and examples,
\nalthough general guides exist.18
\n10\tCouncil for International Organizations of Medical Sciences (CIOMS). CIOMS Guide to Active Vaccine Safety Surveillance (report of
\nthe CIOMS Working Group on Vaccine Safety). Geneva: CIOMS, 2017.
\n11\t Council for International Organizations of Medical Sciences (CIOMS). Definition and application of terms of vaccine pharmacovigilance
\n(report of CIOMS\/WHO Working Group on Vaccine Pharmacovigilance). Geneva: CIOMS, 2012). Accessible at https:\/\/cioms.ch\/
\nshop\/product\/definitions-and-applications-of-terms-for-vaccine-pharmacovigilance\/.
\n12\tAn adverse event following immunization (AEFI) has been defined as any untoward medical occurrence which follows immunization
\nand which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable
\nor unintended sign, abnormal laboratory finding, symptom or disease. AEFIs can be distinguished by cause as vaccine product-
\nrelated reactions, vaccine quality-related reaction, immunization error-related reaction, immunization anxiety-related reaction or be
\ncoincidental events. (see Council for International Organizations of Medical Sciences (CIOMS). Definition and application of terms of
\nvaccine pharmacovigilance (report of CIOMS\/WHO Working Group on Vaccine Pharmacovigilance). Geneva: CIOMS,2012.
\n13\tWorld Health Organization (WHO): Global Manual on Surveillance of Adverse Events Following Immunization. WHO Western Pacific
\nRegional Office, 2012.
\n14\tMinister of Health Canada. Strategic risk communications framework for Health Canada and the Public Health Agency of Canada.
\nOttawa: Minister of Health Canada, 2007. Accessible at: https:\/\/www.canada.ca\/en\/health-canada\/corporate\/about-health-canada\/
\nactivities-responsibilities\/risk-communications.html.
\n15\tFischhoff B, Brewer NT, Downs JS. Communicating risks and benefits: an evidence-based user\u2019s guide. Silver Spring, MD: US Food
\nand Drug Administration, 2009.
\n16\t Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf. 2010,
\n33: 1065-1079.
\n17\t European Medicines Agency (EMA) and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP) \u2013 Annex
\nII \u2013 Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC) Rev 1. London: EMA, 12 October
\n2017. Accessible at: http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/regulation\/document_listing\/document_listing_000345.
\njsp&mid=WC0b01ac058058f32c.
\n18\tCommunicating Risks and Benefits: An Evidence-Based User\u2019s Guide. Published by the Food and Drug Administration (FDA), US
\nDepartment of Health and Human Services, August 2011. Available on FDA\u2019s Web site at http:\/\/www.fda.gov\/ScienceResearch\/
\nSpecialTopics\/RiskCommunication\/ default.htm
\nChapter
\n1.
\nIntroduction
\n6
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nCHAPTER 2.
\nCONSIDERATIONS FOR VACCINE SAFETY
\nCOMMUNICATION
\nThose engaged in vaccine safety communication need to have a clear understanding of their mandates,
\naudiences and aims (see \u00a72.1) and cannot ignore changing contexts in which they operate, in order
\nto adapt for efficient achievements of the aims.
\nThe current situation is that vaccines have been one of the most successful health interventions and
\nvast population groups agree with immunization,19 while at the same time there is a debate in the
\npublic domain around the benefits and risks of vaccines, in particular when a safety concern arises,
\nand some groups and individuals are hesitant or reject vaccines (see \u00a72.4).
\nThe challenge for communication is to operate efficiently in a field of tension between public expectations
\nand concerns, scientific evidence and uncertainty (see \u00a72.2). Vaccine safety communicators must
\nalso pay careful attention to the relationship between communication, transparency and public trust
\n(see \u00a72.3).
\n2.1.
\nAudiences and aims of vaccine safety
\ncommunication
\nThe communication discussed in this report happens between regulatory authorities responsible
\nfor the safety of vaccines as medicinal products and multiple stakeholders, including public health
\nauthorities, immunization advisory committees, ministries of health, manufacturers with their own
\nresponsibility for the safety of their vaccines, healthcare professionals in their intermediary role,
\nand the wider public. The public consists of multiple groups, including in particular those vaccinated
\nor for whom immunization is intended, parents, families and carers, religious, community and public
\nopinion leaders, healthcare professionals, whether modern or traditional, as well as journalists and
\nothers active in the news or social media (see \u00a75.3).
\nThose responsible for infectious disease control often use the social ecological model (SEM) as a
\ntheory-based framework for understanding the multifaceted and interactive effects of personal and
\nenvironmental factors that determine the behaviours of individuals and groups.20 Without going into
\ndetailed recommendations on how this framework could be applied to vaccine safety communication
\nby regulatory authorities, Figure 2.1 below shows how the SEM visualizes the complex relationships
\nbetween the stakeholders and provides a conceptual framework for regulators to create their own
\nlocal SEM and map their interactions.
\n19\t\u201cImmunization\u201d as used in this report means the usage of a vaccine for the purpose of immunizing individuals. It is generally
\nacknowledged that (1) \u201cimmunization\u201d is a broader term than \u201cvaccination\u201d, including active and passive immunization, and (2)
\nimmunization when used strictly implies an immune response. In keeping with other key published literature in the field of immunization,
\nthe terms \u201cimmunization\u201d and \u201cvaccination\u201d are – in general – used interchangeably in the current report. (see Council for International
\nOrganizations of Medical Sciences (CIOMS). Definition and application of terms of vaccine pharmacovigilance (report of CIOMS\/WHO
\nWorking Group on Vaccine Pharmacovigilance). Geneva: CIOMS, 2012). Accessible at: https:\/\/cioms.ch\/shop\/product\/definitions-
\nand-applications-of-terms-for-vaccine-pharmacovigilance\/.
\n20\tUnited Nations Children\u2019s Fund (UNICEF). What are the Social Ecological Model (SEM), and Communication for Development (C4D)?
\nNew York: UNICEF. Accessible at: https:\/\/www.unicef.org\/cbsc\/files\/Module_1_SEM-C4D.docx.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n7
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nFigure 2.1: The social-ecological model (SEM)21
\nPolicy\/Enabling Environment
\n(national, state, local laws)
\nOrganizational
\n(organizations and social institutions)
\nCommunity
\n(relationships between organizations)
\nInterpersonal
\n(families, friends,
\nsocial networks)
\nIndividual
\n(knowledge,
\nattitudes,
\nbehaviors)
\nIn the communication process, the roles of listening and speaking should alternate between
\nstakeholders, who should not be viewed as opponents, but as partners in an exchange over a
\ntopic of major public interest, in order to safeguard health for individuals and as a common good.
\nTherefore, the common language where regulators call stakeholders and especially the general
\npublic and its sub-populations \u2018audiences\u2019 could be misleading if that would be understood as those
\nexpected to listen without having a voice of their own. The term \u2018audience\u2019 is used in this report to
\nrefer to those whom vaccine safety communication systems are supposed to serve, above all the
\npublic as a whole, its sub-populations, and its individual members, healthcare professionals and
\nhealth policy decision-makers.
\nAny party, subgroups or individuals may take particular roles in shaping knowledge, attitudes,
\npractices (KAP) of individuals and groups, but in particular opinion leaders in healthcare, community
\nand religious leaders, journalists, trusted governmental or nongovernmental organizations, and interest
\ngroups like anti-vaccine groups, women\u2019s groups or citizen watchdog groups. An opinion leader can
\nalso come from outside a concerned community or country.
\nIn line with the mandate of regulatory bodies to assess and licence medicines and continuously
\nassess and supervise medicines after licensure, regulatory vaccine safety communication with
\nstakeholders may benefit from having the following communication aims:
\n21\tUnited Nations Children\u2019s Fund (UNICEF). What are the Social Ecological Model (SEM), and Communication for Development (C4D)?
\nNew York: UNICEF. Accessible at: https:\/\/www.unicef.org\/cbsc\/files\/Module_1_SEM-C4D.docx. UNICEF adapted their model from
\nthe Centers for Disease Control and Prevention (CDC), The Social Ecological Model: A Framework for Prevention, http:\/\/www.cdc.
\ngov\/violenceprevention\/overview\/social-ecologicalmodel.html.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n8
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nf
\nf understanding KAP and related concerns and information needs (and ideally underlying mental
\nmodels)22 of the audiences with regard to vaccines;
\nf
\nf providing accurate and full information about the safety profiles and benefit-risk balances of
\nvaccine products for supporting informed choice of individuals and policy-makers in relation to
\nimmunization;
\nf
\nf demonstrating trustworthiness of the vaccine safety surveillance system (pharmacovigilance)
\nfor trust-building; and
\nf
\nf preventing and managing crisis situations due to safety concerns over vaccines.
\nA sub-objective is to provide the information in formats that may support healthcare professionals
\nand vaccinators when communicating with individuals, such as (potential) vaccines (people
\nreceiving vaccinations), carers and community leaders. Communication in the public domain
\nimpacts on interpersonal communication between individuals in healthcare settings, as it occurs
\n(e.g. when discussing informed consent for study participation, proposed vaccination of children,
\nor suspected harm due to a vaccine).
\n2.2.
\nCommunicating evidence and uncertainties for
\ninformed decision-making
\nThe issue of the general individual freedom of choice in life – versus the need for certain behaviours for
\ncommunity good – bears potential for conflict. From a perspective of communication and increasingly
\nshared medical decision-making23 and community participation, the concept of informed choice about
\nwhether to vaccinate or not is widely accepted. Informed choice and the related informed consent
\nare complex concepts and far more demanding than is often understood. There is complexity in the
\nscientific issues and how to communicate them in a way generally understandable as well as in the
\npsychological, political and religious factors of individuals and groups. Informed choice can arise
\nonly when the questions, doubts, preoccupations and emotional needs of individuals and groups are
\naccurately addressed, probably over a long period of time. Even when such concerns are accurately
\naddressed, there may still be vaccine refusal, a decision entirely within the rights of individuals in
\ncountries where the ethical principle of voluntariness is upheld. Choice will arise from a multiplicity
\nof influences with scientific evidence maybe playing a quite minor part, but for informed choice clear
\ncommunication of the evidence is essential.
\nIntrinsic to the scientific approach is to acknowledge that each piece of evidence is surrounded by
\nuncertainty to some degree, depending on the robustness of the evidence. In addition evidence can
\nalso raise new questions and detect areas of missing knowledge. While the most important step
\nis to generate evidence to reduce uncertainty in important areas, decisions will always have to be
\ntaken despite some uncertainty.
\nCommunication for risks is therefore only complete with its evidence-base and honesty over remaining
\nuncertainties, and should at the same time prevent undue amplification of risk perception in society.
\nCommunication interventions can clarify what is known and what is unknown, what confidence one can
\nhave in the robustness of existing knowledge and the current plausibility and relevance of potential
\nunknown issues. Guidance on how to address uncertainty is summarized in Guidance Summary 2.2.
\n22\t Amentalmodelcorrespondstobeliefs,inwhichknowledge,uncertaintiesandunknownsgetmerged.Newinformationisprocessedwithin
\na mental model, and this process is called perception [See Morgan MG, Fischhoff B, Bostrom A, and Atman CJ. Risk communication:
\na mental models approach. Cambridge: Cambridge University Press, 2002. and Slovic P. The feeling of risk: new perspectives on
\nrisk perception. London, Washington DC: Earthscan, 2010.]
\n23\tElwyn G, Edwards A, Thompson R. Shared decision making in health care. 3rd ed. Oxford: Oxford University Press, 2016.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n9
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nGuidance Summary 2.2: Addressing uncertainty in vaccine safety
\nFrom the report on a United States Institute of Medicines (IOM) workshop dedicated to
\ncommunicating uncertainty in relation to pharmaceutical products24, principles for communicating
\nuncertainty in relation to the safety of vaccines can be derived and adapted as follows:
\nf
\nf Gain clarity over the type of uncertainty such as:
\n\u2014
\n\u2014 statistical uncertainty or other methodological limitations of existing evidence,
\n\u2014
\n\u2014 uncertainty based on surrogate primary outcomes (e.g. antibody development, or,
\nfor HPV vaccines, development of genital lesions and warts as surrogate outcome
\nfor cervical cancer risk),
\n\u2014
\n\u2014 uncertainty due to novelty of the vaccine product and early stage of evidence gathering
\nunder real conditions of vaccine use, and
\n\u2014
\n\u2014 uncertainty based on limited evidence at early stage of detecting a signal of a rare
\npotential adverse effect of a vaccine, as the type of uncertainty defines the communication
\ncontent with regard to uncertainty;
\nf
\nf Acknowledge the dynamics of scientific evidence as well as:
\n\u2014
\n\u2014 the complexity of benefit-risk assessment
\n\u2014
\n\u2014 the decision-making processes for regulatory licensure and individual patients, including
\n\u2014
\n\u2014 the need for interpretation of available and missing data;
\nf
\nf Listen to views of the public and explore values of society, in order to establish:
\n\u2014
\n\u2014 principles,
\n\u2014
\n\u2014 thresholds of risk tolerance and
\n\u2014
\n\u2014 benefit-risk trade-offs for decision-making in situation of uncertainty;
\nf
\nf Foster transparency about:
\n\u2014
\n\u2014 robustness of evidence,
\n\u2014
\n\u2014 type of uncertainties,
\n\u2014
\n\u2014 sensitivity analysis of different possible scenarios of areas where data is missing and
\n\u2014
\n\u2014 decision-making, including about
\n\u2014
\n\u2014 how convergence is reached between experts or how divergent views have been
\naddressed;
\nf
\nf Demonstrate, towards the public, commitment and quality assuring processes to achieve
\nbest possible decisions for individual and public health as the outcome of the benefit-risk
\nassessment in situations of uncertainty and focus on thereby earning trust.
\n24\t US Institute of Medicine (IOM). Characterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical
\nproducts – workshop summary. Washington, DC: The National Academies Press, 2014.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n10
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\n2.3.
\nTransparency for honest communication and
\npublic trust-building
\nIn this respect, it is stressed that communication, no matter how skilful and carefully designed, cannot
\nand is not meant to disguise any lack of evidence or uncertainty or flaws in the processes of safety
\nsurveillance, risk management or regulatory decision-making. The link between communication and
\ntransparency is vital.
\nFurther, a prerequisite to the effectiveness of the communication is that the regulatory authority as
\nthe sender of information is trusted as an evidence-based, honest and credible organization known
\nfor its integrity, and that the trustworthiness of the vaccine safety surveillance (pharmacovigilance)
\nsystem is well demonstrated. Guidance on how to build trust in the area of vaccine safety is provided
\nin Guidance Summary 2.3, and is illustrated by Example 2.3.
\nGuidance Summary 2.3: Building trust in vaccine safety
\nA report of the European Centre for Disease Prevention and Control (ECDC)25 on building trust
\nin immunization programmes and the Vaccine Confidence Project at the London School of
\nHygiene & Tropical Medicine26 has been used as the basis for the following recommendations
\nfor regulatory authorities for building trust in the area of vaccine safety:
\nf
\nf Engage in transparency;
\nf
\nf Build professional-personal relationships with all stakeholders (see \u00a75.3) over time and
\nspecifically at local and \u2018grass root\u2019 level for a multistakeholder dialogue;
\nf
\nf Apply the stepwise communication process with monitoring of knowledge, attitudes,
\npractices (KAP) (see \u00a72.1) and related concerns and information needs;
\nf
\nf Foster the participation of all parties in the vaccine assessment and communication
\nprocesses to ensure that public concerns are listened to and are taken seriously;
\nf
\nf Target specifically vaccine-hesitant groups (see \u00a72.4) and those who are undecided and
\nneed information;
\nf
\nf Pay attention to building trust in the safety processes for the vaccines within the healthcare
\nsector, as providers need to feel confident that they are recommending safe and effective
\nvaccines and can confidently answer the growing questions from parents;
\nf
\nf Approach community, religious and political leaders and establish cooperation on vaccine
\nmatters (note that when excluded, such leaders can become barriers to public trust);
\nf
\nf Explain to the public how personal data accruing from these processes are protected;
\nf
\nf Understand barriers to trust in your environment and find solutions to overcome these
\nbarriers;
\nf
\nf Think beyond the vaccine and consider the historical as well as the current societal and
\npolitical factors that could influence public trust;
\nf
\nf Communicate with the public on a new vaccine or a new vaccine safety concern proactively
\nand continuously, in order to avoid:
\n25\tEuropean Centre for Disease Prevention and Control (ECDC). Communication on immunisation: building trust. Stockholm: ECDC,
\n2012. Accessible at: http:\/\/ecdc.europa.eu\/en\/publications\/Publications\/TER-Immunisation-and-trust.pdf.
\n26\tLondon School of Hygiene & Tropical Medicine. The Vaccine Confidence Project; Accessible at: www.vaccineconfidence.org.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n11
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\n\u2014
\n\u2014 information vacuums in the public domain and room for speculations and misleading
\nrumours, and
\n\u2014
\n\u2014 appearing passive and late in investigations and health protection;
\nf
\nf Be prepared for immediate communication in response to queries from the public;
\nf
\nf Be honest in providing information and do not hide uncertainties (see \u00a72.2);
\nf
\nf Add to the key messages bridging information that can connect the new information with
\nthe mental models and KAP (see \u00a72.1) prevalent in the public;
\nf
\nf Keep consistency between messages and explain changes and how new information links
\nwith what was known before;
\nf
\nf Monitor media debates and, in case of misinformation, provide input to debates with
\ncorrective information;
\nf
\nf When countering a negative rumour or misleading information, consider the \u2018fertile ground\u2019
\nfactors that make the rumour popular in the first place and address those in addition to
\nproviding corrective information;
\nf
\nf Consider participating in the certification of the WHO\u2019s Global Advisory Committee on
\nVaccine Safety (GACVS) website: Vaccine Safety Net portal for websites that provide
\ninformation on vaccine safety and adhere to good information practices (http:\/\/www.
\nvaccinesafetynet.org\/);27
\nf
\nf Always be non-judgmental and do not dismiss public concerns because they are based on
\nbelief instead of evidence. Where religious beliefs are involved, find ways to make vaccines
\nacceptable within the given religious belief;
\nf
\nf When engaging and communicating with the public, be respectful and express commitment
\nthrough the tone of messages.
\nSpecific guidance on partnering with religious leaders and groups has been made available by UNICEF.28
\nExample 2.3: Re-building trust in the MMR vaccine in the United Kingdom
\nStarting in 1996, a group based at the Royal Free Hospital, London, United Kingdom (UK)
\npublished a series of articles in scientific journals that purported to show variously that measles
\nvirus, measles vaccine and measles-mumps \u2013rubella (MMR) vaccine were respectively associated
\nwith inflammatory bowel disease and autism. Despite the lack of any credible evidence linking
\nthe measles virus and measles vaccine with bowel disease, nor the MMR vaccine with bowel
\ndisease and autism, the single measles vaccine was advised by health officials as an alternative.
\nDespite these fundamental illogicalities, each pronouncement was given considerable media
\ncredibility supported by parents and lawyers who were seeking compensation.
\n27\tWorld Health Organization (WHO). Vaccine safety net. Accessible at: http:\/\/www.who.int\/vaccine_safety\/initiative\/communication\/
\nnetwork\/vaccine_safety_websites\/en\/.
\n28\tUnited Nations Children\u2019s Fund (UNICEF). Building trust in immunization: partnering with religious leaders and groups. New York:
\nUNICEF; 2004. Available at: https:\/\/www.unicef.org\/publications\/index_20944.html.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n12
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nThe consequence was rapid erosion of trust in the safety of MMR by parents and healthcare
\nprofessionals. Before the onset of fears over MMR vaccine safety, vaccine coverage had
\nbeen more than 90% by the second birthday. Measles had been eliminated from the UK.
\nCoverage fell progressively to a national average of less than 80% with coverage of less than
\n70% in some localities, especially in London. Small outbreaks of measles were restricted by
\nthe previous high population immunity. Much research amongst parents showed that whilst
\nthey were concerned about the safety of MMR, they were not concerned about the potential
\nseriousness of measles.
\nMMR uptake at 16 months and
\nproportion of mothers believing in complete
\nor almost complete safety of MMR vaccine
\nMMR uptake
\n% mothers confident
\n60%
\n70%
\n80%
\n90%
\nA
\np
\nr
\n–
\n9
\n4
\nA
\np
\nr
\n–
\n9
\n5
\nA
\np
\nr
\n–
\n9
\n6
\nA
\np
\nr
\n–
\n9
\n7
\nA
\np
\nr
\n–
\n9
\n8
\nA
\np
\nr
\n–
\n9
\n9
\nA
\np
\nr
\n–
\n0
\n0
\nA
\np
\nr
\n–
\n0
\n1
\nA
\np
\nr
\n–
\n0
\n2
\nA
\np
\nr
\n–
\n0
\n3
\nCrohn\u2019s paper Autism paper
\nSustained negative
\nmedia reportage
\n+ Leo Blair
\nSource: graphic provided with permission by Davis Salisbury, Global Health Security, Chatham
\nHouse, London.29
\n29\t David Salisbury, Centre for Global Health Security, Chatham House, London UK, through email 12 Feb 2016 provided as a PowerPoint
\nslide in document, with reference to presentation by Jo Yarwood, UK Department of Health, Public Health England, 23 October 2012.
\nYarwood credits on slide 15: Thanks to Prof. Brent Taylor, Community Child Health at the Royal Free and University College Medical
\nSchool, London, https:\/\/www.slideshare.net\/meningitis\/jo-yarwood-informing-the-public-about-immunisation.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n13
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nSuch interpretation was entirely rational in the face of repeated media reports raising fears
\nover the MMR vaccine and autism and in the light of measles having been eliminated. Research
\nalso showed that the most trusted sources of health advice were local providers \u2013 general
\npractitioners, practice nurses and health visitors. The UK Department of Health\u2019s communication
\nstrategy was built therefore on ensuring that those providing advice had the best information
\nreadily available to give to parents and to ensure that parents could also easily access sources
\nof trustworthy material. For the former, a suite of materials was developed and tested that
\naddressed concerns from the least to the most literate, readily available in hard copy or online,
\nfor the latter. The website \u201cMMR – The Facts\u201d30 was accessed frequently. It was updated
\nwhenever new information became available and was much valued by parents and journalists.
\nProbably, the most telling event in the turnaround of opinion was the work of the investigative
\njournalist, Brian Deer. His reports, and website, revealed much of the hitherto unknown background
\nof the research probity leading to an investigation by the UK General Medical Council with the
\nconsequence of the removal of the licence to practice of the lead protagonist on the grounds
\nof serious professional misconduct, including \u2018acting dishonestly and irresponsibly.\u2019 From this
\npoint onwards, public opinion and indeed the reporting by journalists changed considerably.
\nMMR vaccine coverage has quietly and consistently risen to its present levels \u2013 back over 90%.31
\nFor communication, it is fundamental to understand the concept of transparency.
\nTransparency refers to an organization\u2019s openness about its activities, providing reliable and timely
\ninformation that is accessible and understandable on what it is doing, where and how its activities take
\nplace, and how the organization is performing, unless the information is deemed confidential.32 This
\nshould include conflict of interest declarations of those involved in assessment and decision\u2011making
\n30\tUK Government Web Archive. NHS Immunisation Information. The Science and history of immunisation and about the vaccines in the
\nroutineUKimmunisationschedule.MMRTheFacts.Archivedon5Jul2009http:\/\/webarchive.nationalarchives.gov.uk\/20090705184233\/
\nhttp:\/\/www.immunisation.nhs.uk\/Vaccines\/MMR
\n31\tExample provided by David Salisbury, Centre for Global Health Security, Chatham House, London, United Kingdom.
\n32\tWorld Health Organization (WHO). WHO accountability framework. Geneva: WHO, 2015.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nas well as documentation how these are managed to avoid partiality, bias and perceptions of undue
\ncommercial influence.33
\nWhile both communication and transparency processes make information available to the public,
\nthey are distinguished by their objectives: transparency serves accountability over decision-
\nmaking; communication aims at behaviours34 – here the informed and safe vaccination behaviours.
\nCommunication and transparency are however linked, because transparency of the communicating
\norganization demonstrates its trustworthiness – provided it meets the expected standards for vaccine
\nassessment – and this makes the communication more effective.35
\nIn the area of vaccine safety, transparency of regulatory authorities should make information, such as
\nassessment reports and meeting minutes, available to the public, as much as possible proactively and
\notherwise upon request. This will allow the public to better understand the data gathering process,
\nas well as the licensing, risk assessment and decision-making processes in which stakeholders are
\ninvolved. By being transparent, authorities can clarify a situation to the public, acknowledge their
\nconcerns and provide relevant information about issues where the public has limited knowledge.36
\nPolicies need to be in place to assure confidentiality of personal data and the quality of the documents
\nmade available to the public.
\n2.4.
\nPerceptions of risk as a trigger of vaccine
\nhesitancy
\nVaccine hesitancy is seen in low, middle and high-income countries around the globe. The term refers
\nto delaying acceptance of or refusing vaccines that are on offer. Vaccine hesitancy is complex and
\nsituation-specific, varying across time, place and vaccine products.37 Although the term vaccine
\nhesitancy has been widely adopted to describe behaviour critical of or hostile to vaccination, it is
\na catch-all category rather than a coherent concept.38 It presumes to cover a very wide range of
\nattitudes and behaviours, influenced by multiple and differential causes and sources, both within
\nindividuals and across populations. It seems to imply an unspecified point on a spectrum from
\nextreme opposition to full acceptance, a point which may not represent truly the entire position of
\nan individual or society as a whole. It does not, for example, easily include at the same time the
\nknowledgeable, vaccine-favouring individual or parent who has questions or doubts about a specific
\nvaccine, the parent critically opposed to all vaccines and the generally ill-informed or difficult-to-
\nreach parent whose children are not brought forward for immunization. For the time being, however,
\nthis report refers to the term vaccine hesitancy as a shortcut for this range of underlying knowledge,
\nattitudes, practices (KAP) and related concerns and information needs.
\nVaccine hesitancy arises in a complex matrix of events and influences, including the proliferation
\nof news and social media as well as website of organizations in the internet, reliable or dubious,
\n33\tEuropean Centre for Disease Prevention and Control (ECDC). Communication on immunisation: building trust. Stockholm: ECDC;
\n2012. Accessible at: http:\/\/ecdc.europa.eu\/en\/publications\/Publications\/TER-Immunisation-and-trust.pdf.
\n34\t Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf. 2010,
\n33: 1065-1079.
\n35\tSlovic P. Perceived risk, trust and democracy. In: Cvetkovich G, L\u00f6fstedt RE, eds. Social trust and the management of risk. London:
\nEarthscan, 1999: 42-52.
\n36\tEuropean Centre for Disease Prevention and Control (ECDC). Communication on immunisation: building trust. Stockholm: ECDC;
\n2012. Accessible at: http:\/\/ecdc.europa.eu\/en\/publications\/Publications\/TER-Immunisation-and-trust.pdf.
\n37\tLarson HJ, Jarret C, Eckersberger E, Smith DM, Paterson P. Understanding vaccine hesitancy around vaccines and vaccination from
\na global perspective: a systematic review of published literature, 2007-2012..
\n38\tPeretti-Watel P, Larson HJ, Ward JK, Schulz WS, Verger P. Vaccine hesitancy: clarifying a theoretical framework for an ambiguous
\nnotion. PLOS Currents Outbreaks. 2015 Feb 25 . Edition 1.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n15
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nof variable quality and often confusing or contradictory. There are many complex and wide-ranging
\nreasons for negative sentiments towards vaccines and vaccine hesitancy (see Figure 2.4), and amongst
\nthem concerns over safety are a major reason for vaccine hesitancy.39
\nFigure 2.4: The WHO Strategic Advisory Group of Experts (SAGE) on Immunization
\nModel of determinants of vaccine hesitancy40
\nVaccine hesitancy may however also come from a general climate of mistrust that is not specific
\nto vaccines, but linked to lack of trust in governments, industry, or science. Among populations in
\nresource-limited countries, some vaccine hesitancy could be related to suspicions of the motivation
\nof donors to or foreign programme management of immunization campaigns. What is often also
\noverlooked is that vaccine hesitancy may be understood, in some situations, as the other side of
\nsimultaneously present positive sentiments towards vaccines, i.e. expectations that they bring benefits
\n39\tLarson HJ, Jarret C, Eckersberger E, Smith DM, Paterson P. Understanding vaccine hesitancy around vaccines and vaccination from
\na global perspective: a systematic review of published literature, 2007-2012..
\n40\tLarson HJ, Jarret C, Eckersberger E, Smith DM, Paterson P, 2007-2012.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n16
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nand should not harm.41 Some argue that high expectations of vaccines may lead to heightened
\nawareness and frustration over risks.42
\nVaccine sentiments, acceptance and hesitancy are not static but may change as their determinants
\nchange over time or suddenly, or as a serious vaccine-preventable disease arises newly or changes
\nin its incidence or severity, due to or independently from immunization. There is a specific potential
\nfor vaccine hesitancy when the public perception of the risk of the disease is low. In particular when
\ndiseases have become rare as the result of immunization programmes (e.g. measles, polio) and
\nthe public has little first-hand experience of the targeted diseases, perceptions of vaccine risks
\nmay be heightened in comparison to the risks of the disease. This contributes to the challenges of
\nvaccine safety communication. On the other hand, when vaccines are perceived to be effective in
\npreventing diseases that people are afraid of, vaccine acceptability can increase. Insufficient vaccine
\navailability may then become an issue, prompting the need to communicate difficult decisions about
\nprioritization of immunization target populations.
\nVaccine hesitancy is not new,43 and there are as number of examples from different parts of the
\nworld where vaccine introduction was rejected en masse by the population intended to benefit from it
\n(e.g. the \u201cRevolt da vacina\u201d in Brazil in 190444 and HPV vaccine rejection by mothers in Romania45).
\nIn another example, religious or political leaders intervened in northern Nigeria46 and Pakistan47 to
\nhinder the polio vaccine immunization programmes. Individual (as opposed to en masse) vaccine
\nhesitancy, though collectively generating large numbers, appears currently to be a feature of high-
\nincome countries.
\nAs the contexts of vaccine hesitancy vary enormously from region to region and from country to
\ncountry, no comprehensive solution can be proposed. The underlying principle of any solution, however,
\nlies in sensitive and empathic engagement and communication with individuals and communities
\nbased on an authentic understanding of the sentiments and concerns of multiple segments of the
\npopulation, in particular those where doubt, resistance, mistrust or hostility is held. Comprehensive,
\ntransparent and comprehensible evidence-based safety information is a critical element of the process,
\nbut only a part. Working on trust-building is essential too (see \u00a72.3). However, vaccine hesitancy can
\nbe addressed, and Guidance Summary 2.4 provides advice about how regulatory authorities can
\ncontribute. While reaching out to vaccine-hesitant populations falls under the remit of the public health
\nagencies and immunization programmes, as described in Example 2.4.1, regulatory authorities can
\nsupport their efforts with providing information about vaccine safety and vaccine pharmacovigilance
\nsystems (see Chapter 3). In return they can use the in-depth audience insights of the immunization
\nprogrammes, in order to ensure that the information needs of all sub-audiences are fulfilled.
\n41\tLeach M, Fairhead J. Vaccine Anxieties: global science, child health and society. London: Taylor & Francis Earthscan; 2007.
\n42\tLeach M, Fairhead J. 2007.
\n43\tThe College of Physicians of Philadelphia. History of anti-vaccination movements. Philadelphia, PA: The College of Physicians of
\nPhiladelphia ; 2017. Accessible at: https:\/\/www.historyofvaccines.org\/content\/articles\/history-anti-vaccination-movements.
\n44\tHochman G. Priority, Invisibility and Eradication: The History of Smallpox and the Brazilian Public Health Agenda. Medical History.
\n2009, 53(2):229-252.
\n45\tCraciun C, Baban A. Who will take the blame?: understanding the reasons why Romanian mothers declined HPV vaccination for their
\ndaughters. Vaccine. 2012; 30: 6789-6793.
\n46\tGhinai I, Willott C, Dadari I, Larson HJ. Listening to the rumours: what the northern Nigeria polio vaccine boycott can tell us ten years
\non. Glob Public Health. 2013; 8: 1138\u20131150. Accessible at: https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4098042\/.
\n47\tWalsh D. Polio crisis deepens in Pakistan. New York Times. 26 Nov 2014. Accessible at: https:\/\/www.nytimes.com\/2014\/11\/27\/
\nworld\/asia\/gunmen-in-pakistan-kill-4-members-of-anti-polio-campaign.html?_r=0.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n17
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nGuidance Summary 2.4: Addressing vaccine hesitancy
\nThe WHO Strategic Advisory Group of Experts (SAGE) on Immunization has reviewed and
\nidentified strategies to address vaccine hesitancy. Based on these strategies,48 the following
\nrecommendations have been formulated for regulatory authorities:
\nf
\nf Aim to increase knowledge and awareness surrounding vaccine safety, efficacy and quality,
\nsafe use advice and pharmacovigilance;
\nf
\nf Tailor the intervention to the relevant populations and their specific concerns or information
\ngaps, including those which are discussed by vaccine-hesitant groups;
\nf
\nf Interact with local communities and healthcare professionals and engage with influential
\nleaders, including religious leaders;
\nf
\nf Introduce education initiatives, particularly those that embed new knowledge into tangible
\nhealth outcomes;
\nf
\nf Employ multi-component communication and follow-ups as needed.
\nIn general, interventions that are applicable to the individual only from a distance (e.g. posters,
\nwebsites, media releases, and radio announcements) have some, but usually smaller benefit
\nthan closer, personal interactions. However, the application of mass media to target parents
\nwith low levels of health service awareness still appears to have a valid place in effective
\ncommunication, and there is good potential for a true positive effect across a larger population.
\nExample 2.4.1: Overcoming hesitancy against the MMR vaccine in sub-populations
\nin Sweden
\nTwo groups in the Swedish population have previously been identified as hard-to-reach for
\nmeasles-mumps-rubella (MMR) immunization, based on documented low vaccination coverage:
\nthe anthroposophic community in J\u00e4rna and the Somali community in Rinkeby and Tensta.
\nThe vaccination coverage among 2-year-olds in 2012 in both these communities was low (4.9%
\nin J\u00e4rna, 69.7% in Tensta and 71.5% in Rinkeby) compared to the national average of 97.2%.
\nJ\u00e4rna is a suburb south of Stockholm with a population of about 7,000 people and about
\n140\u2013150 births per year. A portion of the population follows a lifestyle based upon the
\nphilosophies of Rudolf Steiner who advocated for a holistic view of health with particular
\nviews regarding food, health, and education. Many people practicing an anthroposophic way
\nof life are hesitant towards MMR vaccination, because they believe that a measles infection is
\ngood for the child\u2019s physical and mental health development. Several outbreaks of measles
\nand rubella have occurred in J\u00e4rna and in nearby areas in recent years. In 2012, 23 cases of
\nmeasles and 50 cases of rubella were reported as originating from J\u00e4rna.
\nRinkeby and Tensta are districts located in the northwest part of Stockholm with a high
\npercentage of residents with foreign backgrounds, with 30% of the population of Somali origin.
\nIn 2013, the population in the Rinkeby district was 16,047 people, including 1,638 children
\nunder five years old (8.9%), and in Tensta the population was 18,866 people, including 1,673
\nchildren under five years old (10.2%). In these regions, repeated studies have revealed that
\nSomali women in the area do not want to vaccinate their children against MMR, because they
\nbelieve that the vaccine can cause autism.
\n48\tJarret C, Wilson R, O\u2019Leary M, Eckersberger E, Larson HJ; SAGE Working Group on Vaccine Hesitancy. Strategies for addressing
\nvaccine hesitancy: a systematic review. Vaccine 2015; 33: 4180-4190. .
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n18
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nAs a response, the public health agency of Sweden used a tool developed by WHO Europe
\ncalled Tailoring Immunization Programmes (TIP). The aim of TIP is to identify and increase the
\nknowledge state about vaccines in groups with low vaccination coverage. The TIP methods
\nare based on behavioural theories and planning models for health programmes, including
\nsocial marketing and communication, with focus on behavioural change. TIP includes both an
\nanalysis method to understand the interests, characteristics and needs of different population
\ngroups and individuals in a society as well as tools to support the work of national immunization
\nprogrammes with the goal of designing targeted strategies that increase acceptance of
\nimmunization.
\nThe results of the TIP analysis in Sweden revealed that communication strategies needed to
\nbe strengthened at the local and individual level in these areas with low vaccination coverage
\nand that these interventions should be carried out for an extended period of time. Furthermore,
\ncommunication with healthcare professionals was considered essential to provide them with
\nrelevant and evidence-based information about vaccines as well as about the people\u2019s attitudes
\ntoward them. Parents from the anthroposophic and Somali communities requested neutral
\ninformation about the benefits and risks of vaccines and an objective dialogue with healthcare
\nprofessionals. The Swedish public health agency proposed several targeted communication
\nand education initiatives, including a peer-to-peer project, in-depth educational interventions
\nin vaccinology for healthcare professionals and targeted information about the importance of
\nbeing vaccinated with MMR before travelling abroad.
\nIn their conclusions, the public health agency noted that the project has provided a foundation
\nand guidance for the continued work in communicating about MMR immunization. 49, 50, 51
\nAs vaccine hesitancy can be triggered by safety concerns, it is helpful to understand how cognitive
\nfactors impact on perceptions of risk. This understanding can also be useful for communication
\nplanning and preparedness. The cognitive and psychological decision-making sciences have identified
\na number of characteristics of risks, so-called cognitive factors, which may increase the perception
\nof risk of individuals and groups. These include that a risk may be involuntary, imposed, novel, man-
\nmade, related to technology or result in a dreadful outcome, in particular after a long latency period.
\nOther factors relate to a risk being subject to uncertainty, scientific controversy or public debate.
\nThe most powerful factors are present when a risk possibly concerns women, children, sexuality,
\nreproduction and future generations, or is illustrated by identifiable victims and personal stories.52
\nResearch has also shown that cognitive factors can lead to what is called social risk amplification, i.e.
\na perception of heightened risk, often triggered by debate in groups or society as a whole.53 Where
\ncognitive factors are present, the need for well-prepared and conducted risk communication early on
\nprior to licensure\/launch and throughout the life-cycle of a vaccine can be predicted. Example 2.4.2
\ndemonstrates how applying these findings from risk psychology can help in prioritization efforts in
\n49\t Folkha\u0308lsomyndigheten. Barriers and motivating factors to MMR vaccination in communities with low coverage in Sweden: implementation
\nof the WHO\u2019s Tailoring Immunization Programmes (TIP) method. Solna: Folkha\u0308lsomyndigheten,2015. Accessible under: https:\/\/www.
\nfolkhalsomyndigheten.se\/pagefiles\/20261\/Barriers-motivating-factors-MMR-vaccination-communities-low-coverage-Sweden-15027.pdf.
\n50\tBystr\u00f6m E, Lindstrand A, Likhite N, Butler R, Emmelin M. Parental attitudes and decision-making regarding MMR vaccination in an
\nanthroposophic community in Sweden: a qualitative study. Vaccine. 2014, 32: 6752-6757.
\n51\t Example provided b yChandler R, Uppsala Monitoring Centre (UMC), Sweden, confirmed through personal communication 10 February
\n2016.
\n52\tBennett P. Understanding responses to risk: some basic findings. In: Bennett P, Calman K. Risk communication and public health.
\nOxford: Oxford University Press; 1999. (Quoting Fischhhoff B, Slovic P, Lichtenstein S, Read S, Coombes B. How safe is safe enough?:
\na psychometric study of attitudes towards technological risks and benefits. Policy Science. 1978, 9: 127-152.; Gardner GT, Gould
\nLC. Public perceptions of risks and benefits of technology. Risk Analysis. 1989, 9: 225-242.; Slovic P. Informing and educating about
\nrisks. Risk Analysis. 1986, 6: 403-415.)
\n53\tKasperson RE, Renn O, Slovic P, Brown HS, Emel J, Goble R, et al. The social amplification of risk: a conceptual framework. Risk
\nAnalysis. 1988, 8: 177-187.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n19
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nthe area of vaccines. While a number of cognitive factors are present in many vaccines, some are
\nspecific to certain vaccines.
\nExample 2.4.2: The need for understanding public concerns over HPV vaccines
\nprior to licensure and launch
\nVaccines against the human papillomavirus (HPV) were licensed as of 2006 and the public
\ndebate prior to their licensure and launch in various countries of the world demonstrates the
\nrelevance of understanding cognitive factors in vaccine safety communication, to enable
\naddressing concerns pro-actively through risk assessment and communication.
\nResearch has identified a number of cognitive factors that have the potential to increase risk
\nperception in a society. These factors include relatedness of a topic to children, women,
\nsexuality, reproduction and future generations.54 Given the transmission of HPV through sexual
\nbody contact and given the protection against cervical cancer as the major objective of HPV
\nimmunization in adolescents, the factors children\/women and sexuality, and subsequently
\nreproduction and future generations were obviously present in the case of HPV vaccines from
\nthe onset. The initial immunization strategy focusing exclusively on girls further reinforced
\nthe social amplification of risk perception.55 The media in some countries also portrayed the
\nvaccine as \u201cexperimental\u201d.56 Novelty, uncertainty and scientific debate are further cognitive
\nfactors increasing risk perception.57 On the whole, the presence of cognitive factors for HPV
\nvaccines was predictive of the need for a specific and careful communication strategy.
\nIn the scientific as well as general media concerns were raised indeed over benefit, i.e. vaccine
\neffectiveness long-term, effects on natural immunity, future HPV strain replacement,58, 59, 60, 61,
\n62, 63 as well as over safety.64 Safety concerns discussed in many different countries related
\n54\tBennett P. Understanding responses to risk: some basic findings. In: Bennett P, Calman K. Risk communication and public health.
\nOxford: Oxford University Press; 1999. (Quoting Fischhhoff B, Slovic P, Lichtenstein S, Read S, Coombes B. How safe is safe enough?:
\na psychometric study of attitudes towards technological risks and benefits. Policy Science. 1978,9: 127-152.; Gardner GT, Gould
\nLC. Public perceptions of risks and benefits of technology. Risk Analysis. 1989, 9: 225-242.; Slovic P. Informing and educating about
\nrisks. Risk Analysis. 1986; 6: 403-415.)
\n55\t Thompson M. Who\u2019s guarding what? \u2013 a post-structural feminist analysis of Gardasil discourses. Health Commun. 2010, 25: 119-130.
\n56\tRondy M, van Lier A, van de Kassteele J, Rust L, de Melker H. Determinants for HPV vaccine uptake in the Netherlands: A multilevel
\nstudy. Vaccine. 2010,28: 2070-2075.
\n57\tBennett P. Understanding responses to risk: some basic findings. In: Bennett P, Calman K. Risk communication and public health.
\nOxford: Oxford University Press; 1999. (Quoting Fischhhoff B, Slovic P, Lichtenstein S, Read S, Coombes B. How safe is safe enough?:
\na psychometric study of attitudes towards technological risks and benefits. Policy Science. 1978, 9: 127-152.; Gardner GT, Gould
\nLC. Public perceptions of risks and benefits of technology. Risk Analysis. 1989, 9: 225-242.; Slovic P. Informing and educating about
\nrisks. Risk Analysis. 1986; 6: 403-415.)
\n58\tRondy M, van Lier A, van de Kassteele J, Rust L, de Melker H. Determinants for HPV vaccine uptake in the Netherlands: A multilevel
\nstudy. Vaccine. 2010, 28: 2070-2075.
\n59\tGerhardus A, Razum O. A long story made too short: surrogate variables and the communication of HPV vaccine trial results. J
\nEpidemiol Community Health. 2010, 64: 377-378.
\n60\tNghi NQ, Lamontagne DS, Bingham A, Rafiq M, Mai le TP, Lien NT, Khanh NC, Hong DT, Huyen DT, Tho NT, Hien NT. Human
\npapillomavirus vaccine introduction in Vietnam: formative research findings. Sex Health. 2010, 7: 262-270.
\n61\t Rothman SM, Rothman DJ. Marketing HPV vaccine: implications for adolescent health and medical professionalism. J Am Med Assoc.
\n2009, 302: 781-786.
\n62\tSherris J, Friedman A, Wittet S, Davies P, Steben M, Saraiya M. Education, training, and communication for HPV vaccines. Vaccine.
\n2006, 24 Suppl 3: S3 210-218 (chapter 25).
\n63\tTafuri S, Martinelli D, Vece MM, Quarto M, Germinario C, Prato R. Communication skills in HPV prevention: an audit among Italian
\nhealthcare workers. Vaccine. 2010, 28: 5609-5613.
\n64\t Friedman AL, Shepeard H. Exploring the knowledge, attitudes, beliefs, and communication preferences of the general public regarding
\nHPV: findings from CDC focus group research and implications for practice. Health Educ Behav. 2007, 34: 471-485.
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n20
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nto the exposure of \u201cyoung girls\u201d,65 to the burden of \u201ctoo many vaccines\u201d,66 and to the potential
\nfor adverse reactions,67, 68, 69, 70 fatal outcomes71 and long-term safety.72 A specific concern
\nwas voiced about the impact of the vaccine on female fertility.73 In low resource healthcare
\nsettings concerns over vaccine product quality, use of expired products and unsafe injection
\nadded to the fears.74 Beyond quality and safety, social concerns arose that HPV immunization
\nwould increase early and multi-partner sexual activity.75, 76, 77
\nIn any case, communicating about HPV immunization requires addressing intimate matters
\nwith young people, including whether sexual activity has started or not, and this constitutes
\na communication challenge in and of itself.78 Some of the initial public concerns could in the
\nmeantime be addressed by evidence from long-term and real-life research in the period after
\nlicensure and launch of the HPV vaccines.79 Also an increase of unsafe sexual activity or
\nnegative pregnancy outcomes could be refuted.80, 81
\nOne might wonder if despite all the awareness one had or could have had with looking at the
\nHPV vaccine launch from a cognitive factors perspective, whether communication strategies
\nat launch were optimal in all countries and in particular whether they supported adequately
\nhealthcare professionals (HCPs). HCPs might have felt pretty alone with all the questions raised
\nin the public domain, having to talk to young people about intimate matters and overcoming
\nvaccine anxiety of individuals arising from both these constellations. HCPs need most certainly
\nto be provided with in-depth information from the vaccine development phase onwards, as they
\noften prefer to form their own conclusions. Nowadays researches get increasingly involved in
\nsurveys prior to HPV vaccination programs to inform the information campaigns.82
\n65\tTafuri S, Martinelli D, Vece MM, Quarto M, Germinario C, Prato R. Communication skills in HPV prevention: an audit among Italian
\nhealthcare workers. Vaccine. 2010, 28: 5609-5613.
\n66\tSherris J, Friedman A, Wittet S, Davies P, Steben M, Saraiya M. Education, training, and communication for HPV vaccines. Vaccine.
\n2006, 24 Suppl 3: S3 210-218 (chapter 25).
\n67\tBingham A, Drake JK, LaMontagne DS. Sociocultural issues in the introduction of human papillomavirus vaccine in low-resource
\nsettings. Arch Pediatr Adolesc Med. 2009, 163: 455-461.
\n68\tBrown EC, Little P, Leydon GM. Communication challenges of HPV vaccination. Fam Pract. 2010, 27: 224-229.
\n69\tChow SN, Soon R, Park JS, Pancharoen C, Qiao YL, Basu P, Ngan HY. Knowledge, attitudes, and communication around human
\npapillomavirus (HPV) vaccination amongst urban Asian mothers and physicians. Vaccine. 2010, 28: 3809-3817.
\n70\tRondy M, van Lier A, van de Kassteele J, Rust L, de Melker H. Determinants for HPV vaccine uptake in the Netherlands: A multilevel
\nstudy. Vaccine. 2010, 28: 2070-2075.
\n71\tNghi NQ, Lamontagne DS, Bingham A, Rafiq M, Mai le TP, Lien NT, Khanh NC, Hong DT, Huyen DT, Tho NT, Hien NT. Human
\npapillomavirus vaccine introduction in Vietnam: formative research findings. Sex Health. 2010, 7: 262-270.
\n72\tBrown EC, Little P, Leydon GM. Communication challenges of HPV vaccination. Fam Pract. 2010, 27: 224-229.
\n73\tNghi NQ, Lamontagne DS, Bingham A, Rafiq M, Mai le TP, Lien NT, Khanh NC, Hong DT, Huyen DT, Tho NT, Hien NT. Human
\npapillomavirus vaccine introduction in Vietnam: formative research findings. Sex Health. 2010, 7: 262-270.
\n74\tBingham A, Drake JK, LaMontagne DS. Sociocultural issues in the introduction of human papillomavirus vaccine in low-resource
\nsettings. Arch Pediatr Adolesc Med. 2009, 163: 455-461.
\n75\t Friedman AL, Shepeard H. Exploring the knowledge, attitudes, beliefs, and communication preferences of the general public regarding
\nHPV: findings from CDC focus group research and implications for practice. Health Educ Behav. 2007, 34: 471-485.
\n76\tSherris J, Friedman A, Wittet S, Davies P, Steben M, Saraiya M. Education, training, and communication for HPV vaccines. Vaccine.
\n2006, 24 Suppl 3: S3 210-218 (chapter 25).
\n77\tTafuri S, Martinelli D, Vece MM, Quarto M, Germinario C, Prato R. Communication skills in HPV prevention: an audit among Italian
\nhealthcare workers. Vaccine. 2010, 28: 5609-5613.
\n78\tBrown EC, Little P, Leydon GM. Communication challenges of HPV vaccination. Fam Pract. 2010, 27: 224-229.
\n79\t World Health Organization (WHO). Global Advisory Committee on Vaccine Safety Statement on safety of HPV vaccines. Gen\u00e8ve: WHO,
\n17 December 2015. Accessible under: http:\/\/www.who.int\/vaccine_safety\/committee\/topics\/hpv\/en\/.
\n80\tV\u00e1zquez-Otero C. Dispelling the myth: exploring associations between the HPV vaccine and inconsistent condom use among college
\nstudents. Prev Med. 2016, 93: 157-150.
\n81\tHansen BT. No evidence that HPV vaccination leads to sexual risk compensation. Hum Vaccin Immunother. 2016, 12: 1451-1453.
\n82\tExample provided by Priya Bahri, European Medicines Agency (EMA).
\nChapter
\n2.
\nConsiderations
\nfor
\nvaccine
\nsafety
\ncommunication
\n21
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nCHAPTER 3.
\nPRODUCT LIFE-CYCLE MANAGEMENT
\nAPPROACH TO VACCINE SAFETY AND
\nCOMMUNICATION
\n3.1.
\nCommunication as part of vaccine
\npharmacovigilance
\nVaccine pharmacovigilance has been defined as the science and activities relating to the detection,
\nassessment, understanding and communication of adverse events following immunization and other
\nvaccine- or immunization-related issues, and to the prevention of untoward effects of the vaccine
\nor immunization.83 Communication about potential risks, demonstrated safety and measures to
\nminimize risks, and programmes to support safe and effective use of vaccines, here referred to as
\n\u201cvaccine safety communication,\u201d are therefore a recognized part of pharmacovigilance. So far, for all
\nmedicinal products, the implementation of established principles and guidance on communication
\nprocesses has been slow and incomplete worldwide.84, 85
\nFundamental to achieving the aims of vaccine safety communication (see \u00a72.1) is addressing
\nnot only safety concerns identified by specialists, but also those concerns voiced by the general
\npublic, (potential) vaccinees and their parents as well as healthcare professional (HCP). A strategic
\napproach to vaccine safety communication with collaborative links between all stakeholders has
\nbeen proposed for medicinal products in general86 and for vaccines in particular87 (see Chapter 4).
\nThis can be integrated with the processes for monitoring and assessing the benefit-risk balances of
\nvaccines, so that concerns and information needs voiced by the public are included in benefit-risk
\nmonitoring and assessments.
\nData to be communicated are not only those about safety itself but also those contextualizing a risk
\nor an AEFI case(s), e.g. with data on disease epidemiology, vaccine use\/exposure rates, baseline
\nrates of events which can occur with and without vaccination and baseline pregnancy outcome
\ndata. A pharmacovigilance system therefore needs to collect such data not only for appropriate risk
\nassessment, but also for communication. These data should be collected routinely and proactively,
\nin order to allow for quick and valid assessments (see Example 2.3).
\nFor effective communication and trust-building, it is likewise fundamental to be transparent in relation to
\nthe public about the pharmacovigilance processes in place, the available data, remaining uncertainties
\n83\t Council for International Organizations of Medical Sciences (CIOMS). Definition and application of terms of vaccine pharmacovigilance
\n(report of CIOMS\/WHO Working Group on Vaccine Pharmacovigilance). Geneva: CIOMS, 2012. Accessible at: https:\/\/cioms.ch\/
\nshop\/product\/definitions-and-applications-of-terms-for-vaccine-pharmacovigilance\/
\n84\tBahri P, Harrison-Woolrych M. Focussing on risk communication about medicines [editorial]. Drug Saf. 2012, 35: 971-975.
\n85\tBahri P, Dodoo AN, Edwards BD, Edwards IR, Fermont I, Hagemann U, Hartigan-Go K, Hugman B, Mol PG (on behalf of the ISoP
\nCommSIG). The ISoP CommSIG for improving medicinal product risk communication: a new special interest group of the International
\nSociety of Pharmacovigilance. Drug Saf. 2015, 38: 621-627.
\n86\t Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf. 2010,
\n33: 1065-1079.
\n87\tLarson H. The globalization of risk and risk perception: why we need a new model of risk communication for vaccines. Drug Saf.
\n2012, 35: 1053-1059.
\nChapter
\n3.
\nProduct
\nlife-cycle
\nmanagement
\napproach
\nto
\nvaccine
\nsafety
\nand
\ncommunication
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nand the rationale for decisions taken. It must be demonstrated that the pharmacovigilance processes
\nand data are robust and conducted in an unbiased manner (see Example 4.3.2 concerning the HPV
\nvaccine media monitoring at EMA).
\nVaccine safety communication is a task that is continuously necessary during the entire life-cycle of
\na vaccine product, beginning at the time of vaccine development, especially crucial at the time of
\nlicensure\/launch and to be maintained long-term throughout the post-licensure phase. As the safety
\ndata base for a vaccine will increase over time, but also new safety concerns may be identified,
\nthe messages to be communicated will evolve throughout the life-cycle. Pharmacovigilance nowadays
\nis increasingly proactive in collecting safety data and risk minimization through applying a risk
\nmanagement approach, for which planning should start already before a vaccine gets licensed for
\nuse (see \u00a73.2).
\n3.2. Pre-licensure and launch phase
\nTwo distinct processes occur when a new vaccine first becomes publicly available. One is the licensure88
\nby relevant regulatory authorities to ensure that a product is of ensured quality, safety and efficacy
\nand to specify the conditions for its safe and effective launch and usage in this jurisdiction in public
\nand private healthcare. The second is the launch of the vaccine by immunization programs in wide
\nor focused target populations in order to achieve specified diseases control and health objectives.
\nSometimes, in countries of limited regulatory resources and\/or other regulatory priorities, vaccines
\nwill be launched in immunization programs relying on prior licensure in well-established jurisdictions,
\nwithout separate local licensure.89
\nPublic awareness about a vaccine product may already begin prior to licensure and launch in early
\nclinical development of a vaccine, particularly if it is being developed in response to an unmet
\nhealth need or a current public health emergency. Examples are the malaria vaccine and the Ebola
\nvaccines. The development of the latter has been catalysed by the West African Ebola epidemic of
\n2014\/2015, and overall results from both phase 1 and 2 studies were communicated by various
\nmedia outlets, although no single vaccine had yet been authorized (see Example 3.2.1).
\nExample 3.2.1: The need for understanding concerns in different communities
\nover the Ebola virus and vaccines prior to launching clinical trials
\nIn response to the Ebola virus outbreak in West Africa in 2014, several candidate vaccines
\nthat had demonstrated efficacy in animal models and could be produced at clinical grade,
\nwere evaluated through a series of clinical trials. From the third quarter of 2014, phase 1 trials
\nwere conducted concurrently in North America and Europe as well as in some African countries
\nthat were not affected by the outbreak. By the first quarter of 2015, three phase 3 trials were
\n88\tThe terms \u201capproval\u201d, \u201cauthorization\u201d and \u201clicensure\u201d in the context of vaccine (and drug) regulation in different jurisdictions mean the
\ndeclaration by a regulatory authority that a product following review was found to have a positive benefit-risk profile and is approved
\nfor marketing and use. For consistency we have adopted \u201clicensure\u201d to cover any of these regulatory procedures or declarations.
\n\u201cMarketing\u201d (or \u201cpost-marketing\u201d, etc.) is usually used to describe the phase of vaccine distribution following the manufacturer\u2019s
\ndecision to market the vaccine. The manufacturer may decide not to market a product even though licensure has been granted
\nby the regulatory authority. While \u201cmarketing\u201d differs in meaning, we have adopted, for consistency, the terms \u201cpre-licensure\u201d and
\n\u201cpost-licensure\u201d throughout this report to include everything that follows licensing of the product (i.e. \u201cpost-licensure\u201d includes post-
\nmarketing considerations that would apply in the specific context in which the term is used) (see Council for International Organizations
\nof Medical Sciences (CIOMS). Definition and application of terms of vaccine pharmacovigilance (report of CIOMS\/WHO Working Group
\non Vaccine Pharmacovigilance). Geneva: CIOMS, 2012. Accessible at: https:\/\/cioms.ch\/shop\/product\/definitions-and-applications-
\nof-terms-for-vaccine-pharmacovigilance\/.
\n89\tCouncil for International Organizations of Medical Sciences (CIOMS). CIOMS Guide to Active Vaccine Safety Surveillance (report of
\nthe CIOMS Working Group on Vaccine Safety). Geneva: CIOMS, 2017, Appendix I: Essential Vaccine Information, pp.57-59.
\nChapter
\n3.
\nProduct
\nlife-cycle
\nmanagement
\napproach
\nto
\nvaccine
\nsafety
\nand
\ncommunication
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\ninitiated in the three most affected countries (Liberia, Sierra Leone and Guinea). Despite the
\nunprecedented pace in a vaccine clinical development process, these trials complied with
\ngood clinical practices that are today expected in clinical research.
\nPlanning and implementing those vaccine efficacy trials involved several communication
\nchallenges related to what was known about the vaccines, the selection of vaccine recipients and
\ncontrols, and respecting an informed consent of participants with limited literacy. The general
\nacceptability of the intervention was also subject to concern initially, as outbreak control
\nmeasures had been complicated by traditional rituals, perception of disease transmission
\nand mistrust on the part of several communities.
\nIn each country, investigation teams, including communication professionals, worked closely
\nwith political and religious leaders to identify perception issues related to prevention of Ebola
\nvirus disease and use of an experimental vaccine, serving as advocates for the population.
\nLocal workers and communities were engaged to present the study purposes. Where the
\nprotocol included vaccination of frontline workers, national and local public figures were
\nvaccinated early in some trials to ease population concerns and to indicate that supporting
\nthe evaluation of vaccines against Ebola virus was a collective responsibility90.
\nAt the time of licensure, knowledge about the safety of a vaccine is still limited. Most vaccine trials
\nare designed with a primary objective for efficacy, and their typical size of a couple of thousands
\nsubjects limits the detection of adverse events to those that occur at a frequency > 1\/1000.91 As
\na result, most of the safety information included in the product label is limited to those events that
\noccur in 1\/10 – 1\/100 patients, and largely these events describe the expected local injection site
\nreactions and systemic events of fever and malaise.
\nIn contrast, post-licensure use of vaccines is widespread with exposure in up to millions of subjects.
\nTherefore, even adverse events occurring more rarely, between 1\/1,000 – 1\/10,000, and thus not
\nobserved in clinical trials, may affect thousands of individuals. Furthermore, most pre-licensure
\nclinical trials exclude certain populations, such as premature infants, pregnant women, or people
\nwith underlying medical conditions. However, after launch vaccines are usually given universally
\nand may be, depending on the vaccine type and disease to prevent, encouraged in precisely those
\npopulations excluded from clinical trials, e.g. pregnant women or older patients with multiple diseases.
\nTherefore it is crucial, prior to licensure, to adequately explore and document the gaps in the
\nsafety database and plan how to fill these as quickly as possible in the post-licensure phase. Also it
\nneeds to be planned how to minimize and prevent harm from identified or potential risks. A risk
\nmanagement approach supports documenting how data are collected and risk minimization measures
\nare implemented and to decide, in the light of the results, if and how vaccine safety needs to be
\nfurther improved. While requirements for risk management systems may be tailored to the specific
\nneeds and environment of a country, the concept is universal (see Guidance Summary 3.2.1). There
\na number of risk minimization measures available for medicines (see Guidance Summary 3.2.2),
\nand they mostly require communication for their implementation.
\n90\tExample provided by Dr. Andrea Vicari, Advisor Epidemic-Prone Diseases, Pan American Health Organization (formerly at WHO HQ),
\nper communication with Dr. Patrick Zuber, 28\/08\/2017.
\n91\tEuropean Medicines Agency (EMA). CHMP note for guidance on the clinical evaluation of vaccines. London: EMA, 2005.
\nChapter
\n3.
\nProduct
\nlife-cycle
\nmanagement
\napproach
\nto
\nvaccine
\nsafety
\nand
\ncommunication
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nGuidance Summary 3.2.1: Concept of risk management systems for medicinal
\nproducts
\nA major conceptual example for risk management systems comes from the European Union
\n(EU). An EU risk management system was defined for the pharmaceutical sector first in 2005
\nand later in legislation as a set of pharmacovigilance activities and interventions designed to
\nidentify, characterize, prevent or minimize risks relating to a medicinal product, including the
\nassessment of the effectiveness of those interventions92 (see Figure 3.2).
\nThe submission of risk management plans describing product-specific risk management systems
\nhave become a regulatory requirement for applicants\/ marketing authorization holders in the EU,
\ncommonly known as EU-RMP. These have to be submitted, using a defined template, with the
\nlicensure application for every new medicinal product (including new generics) or for existing
\nproducts with a major safety concern. An EU-RMP describes what is known and not known
\nabout the safety profile of the concerned medicinal product, indicates how so-called missing
\ninformation will be filled and the safety profile of the product further characterized through future
\ndata collection, and demands measures to be taken for prevention or minimizing identified or
\npotential risks (see Guidance Summary 3.2.2). Summaries of the risk management plans for
\nthe public are made available on the European Medicine Agency\u2019s website.93
\nFigure 3.2: Risk management cycle
\nImprove safe use of
\nproduct throught additional
\ndata collection and risk
\nminmisation measures as
\nnecessary
\nDescribe identifed and
\npotential risks and missing
\ninformation of the product
\nCollect data for further risk
\nidentification and
\ncharacterisation and
\noverall assessment
\nTake measures to
\nprevent and
\nminimise identified
\nand potential risks
\nand possibly
\nprecautionary
\nmeasures related to
\nmissing information
\nEvaluate effectiveness of
\nrisk minimisation measures
\nSource: European Medicines Agency, 2012.94
\n92\t Directive 2001\/83\/EC of the European Parliament and of the Council, Article 1(28b).
\n93\t European Medicines Agency and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices – Module V Revision
\n2: Risk management systems. Accessible at: http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/regulation\/document_listing\/
\ndocument_listing_000345.jsp&mid=WC0b01ac058058f32c.
\n94\tEuropean Medicines Agency (EMA) and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices – Module V:
\nRisk management systems. EMA\/838713\/2011. London: EMA, 2012. 20 February 2012, p.7. Accessible at: http:\/\/www.ema.
\neuropa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2012\/02\/WC500123208.pdf.
\nChapter
\n3.
\nProduct
\nlife-cycle
\nmanagement
\napproach
\nto
\nvaccine
\nsafety
\nand
\ncommunication
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nGuidance Summary 3.2.2: Types of risk minimization measures for medicinal
\nproducts
\nProduct information:
\nf
\nf Package leaflet
\nf
\nf Product information for healthcare professionals (e.g. in the EU this is the summary of
\nproduct characteristics (SmPC))95
\nf
\nf Labelling on the outer packaging
\nf
\nf Pack size and design
\nf
\nf Educational materials
\nf
\nf Direct healthcare professional communications (DHPC)96
\nf
\nf Legal status of the product, e.g. prescription-only
\nf
\nf Controlled access programs
\nThe application of risk minimization measures to vaccines can be more challenging. For example
\nthe leaflet for the patient is rarely handed over to the vaccinee or the carer as part of the package,
\nbecause, unlike for other medicinal products, vaccines are often not provided to individuals in the
\npharmacy but administered immediately in the clinic or another vaccination site. An example is provided
\nof a risk management plan for a vaccine assessed in the European Union (EU) in collaboration with
\nWHO in Example 3.2.2. Consideration has to be given as to how to communicate the safety advice
\nin the package leaflet amongst carers, to ensure that any possible risks are avoided and that carers
\nknow how to limit the impact of an adverse reaction should it occur. This may be an objective of a
\nVaccine Safety Communication Plan (see Chapter 4).
\nExample 3.2.2: Risk management planning for DTPw-HBV quadrivalent vaccine
\nA quadrivalent combined bacterial and viral vaccine protecting against diphtheria, tetanus,
\npertussis and hepatitis B, and was assessed by the European Medicines Agency (EMA) in
\ncollaboration with WHO, in order to facilitate its use in countries outside the European Union
\n(EU). Based on the clinical trials, the following was classified as \u2018important identified risks\u2019:
\nallergic reactions, high fever, convulsions, hypotonic-hyporesponsive episodes; and the following
\nas \u2018important potential risks\u2019: apnoea in prematurely born children, fainting, brain disorder.
\nIn addition, the lack of safety and immunogenicity in children born prematurely was classified
\nas \u2018missing information\u2019. Given these safety specifications, no risk minimization measures other
\nthan the product information were considered necessary.97 Information on the identified and
\npotential risks, including warnings and precautions for use to minimize their occurrence and
\n95\tEuropean Medicines Agency (EMA) and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices – Module XVI,
\nRev 2: Risk minimisation measures: selection of tools and effectiveness indicators. London: EMA, 2017. Accessible at: http:\/\/www.
\nema.europa.eu\/ema\/index.jsp?curl=pages\/regulation\/document_listing\/document_listing_000345.jsp&mid=WC0b01ac058058f32c.
\n96\tDHPC is considered an additional risk minimization measure beyond routine measures. For more information, see CIOMS IX Report
\non Risk Minimisation for Medicinal Products, Geneva, Switzerland, 2014.
\n97\tEuropean Medicines Agency (EMA). Summary of the risk management plan (RMP) for Tritanrix HB [Diphtheria, tetanus, pertussis
\n(whole cell) and hepatitis B (rDNA) vaccine (adsorbed)]. London: EMA, 2014. Accessible at: http:\/\/www.ema.europa.eu\/docs\/en_GB\/
\ndocument_library\/Medicine_for_use_outside_EU\/2014\/03\/WC500163201.pdf.
\nChapter
\n3.
\nProduct
\nlife-cycle
\nmanagement
\napproach
\nto
\nvaccine
\nsafety
\nand
\ncommunication
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nseverity of impact, has been included in the package leaflets for carers and the healthcare
\nprofessional information.98, 99
\nThe next example (Example 3.2.3) demonstrates a successful launch of a new vaccine in India in
\na climate of controversy in the public domain. While the example is taken from an immunization
\nprogram rather than communication by a regulatory authority, the approach taken to work with
\nstakeholders is equally applicable to pharmacovigilance.
\nExample 3.2.3: The introduction of pentavalent vaccines in Kerala, India,
\nsupported by close interactions with the healthcare community and the media
\nPentavalent vaccines, protecting against five potentially deadly diseases, namely diphtheria, tetanus,
\npertussis, hepatitis B and Haemophilus influenzae type b (Hib), have been introduced successfully
\nin India. Some federal states became even early adopters with the help of communication efforts,
\ndespite controversies prior to launch. Some individuals, active in alternative medicine but also
\nother healthcare professionals, questioned the utility and safety of the vaccines, and mainstream
\ndaily newspapers joined in, opposing the introduction of the vaccines in the State of Kerala.
\nIn response, a committee of local paediatricians and community doctors was constituted,
\nto examine in detail the issues raised and to prepare a full assessment of the benefit-risk
\nbalance of pentavalent vaccines, taking into account the burden of infectious diseases and all
\navailable published and unpublished data on the vaccines. The committee concluded that the
\nbenefit-risk balance was positive, and a comprehensive communication strategy was applied.
\nThis strategy started with a workshop, convened by the State and with support of UNICEF,
\non 17 November 2011, with the officers from State departments, the heads of the paediatric
\nand community medicine of all medical colleagues and further concerned officials, to present
\nthe report. Immunization guidelines, comprehensively addressing not only information on the
\nvaccine products themselves, but also on safe injection technique, cold chain requirements and
\nsurveillance of potential adverse events, were disseminated in English and the local language.
\nImmunization cards with the correct dosing were disseminated as well.
\nThis was accompanied by actual assessment of the equipment, a wide-reaching training
\nprogramme and a supervision plan for the daily monitoring of the immunization programme.
\nFurther advocacy workshops were organized and a number of mass communication materials
\nin print and electronically were disseminated: posters, booklets and displays in major daily
\nnewspapers. In areas of known vaccine hesitancy, closer interactions with these communities
\nwere sought at various levels, including with those active in media folk arts and healthcare.
\nAs regards interacting with the media, a specific press-conference was held to present the
\ncommittee report, and the fact that this was called by the Minister of Health demonstrated
\nhighest leadership and commitment to safe immunization. This was followed up by media
\nsensitization activities prior to launch of the immunization programme, and these helped to
\nreduce undue criticism over vaccine safety in the media. Even when later, one baby sadly died
\npost-vaccination (note: death proved to be unrelated), the media reported on the examinations
\ndone and the fact that all other children who had been vaccinated from the same vial were
\nhealthy, and continued engaging in immunization advocacy.
\n98\tEuropean Medicines Agency (EMA). Trintanrix HB: product information. London: EMA, 2014. Accessible at: http:\/\/www.ema.europa.
\neu\/docs\/en_GB\/document_library\/Medicine_for_use_outside_EU\/2014\/03\/WC500163198.pdf.
\n99\tExample provided by Priya Bahri, European Medicines Agency, London, United Kingdom.
\nChapter
\n3.
\nProduct
\nlife-cycle
\nmanagement
\napproach
\nto
\nvaccine
\nsafety
\nand
\ncommunication
\n27
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nHowever, a communication strategy is never completed. As pharmacovigilance is a continuous
\nactivity in the post-authorization phase of vaccines as of all other medicines, so is communication
\nwith the public.
\nThe events in the media in India after the successful launch of the immunization programme
\nin Kerala in 2012 illustrate this. Routine media monitoring revealed the following: of the 383
\nnews stories on the pentavalent vaccine in all India from January 2013 onward, 57% coverage
\nwas positive, while 21.5% coverage negative. In the course of 2013 however an increased
\ntendency of the media to hold the vaccine responsible for deaths and to portray the vaccine
\nsensationally was observed. Overall in 2013, 40% of the media coverage was negative.
\nA consistent lack of correct reporting on the vaccine and a need of re-sensitizing the media
\nabout the importance of immunization was identified. As a result, UNICEF along with its partners,
\nheld a series of media sensitization workshops and roundtable discussions in major cities
\nacross India, i.e. in New Delhi, Chandigarh, Lucknow, Chennai, Raipur, Patna, Bhopal, Jaipur,
\nKolkata and Guwahati. A number of senior editors from the print, electronic and broadcast
\nmedia operating in Hindi or English were engaged. Guidance for spokespersons about how
\nto interact with the media during an investigation of an adverse event following immunization
\nwas also provided at trainings for immunization officers. A number of field visits of senior
\njournalists were organized to various states and hard to reach area in Assam, Jharkhand, Uttar
\nPradesh, Bihar, Odisha and Madhya Pradesh, among others.
\nAn analysis of print media articles conducted after this engagement with the media on
\nroutine immunization issues revealed that, compared to 2013, positive coverage on the
\npentavalent vaccine increased in 2014 by 126% and the negative coverage on the vaccine
\nfell by 66%.\u00a0This was also partly due to the parallel media engagement being undertaken
\nfor \u201cMission Indradhanush,\u201d the Indian government\u2019s initiative launched in December 2014 to
\nensure that all children under the age of two and pregnant women are fully immunised with all
\navailable vaccines.100 There was an increase in balanced coverage and the tendency of the
\nmedia to hold pentavalent vaccine responsible for deaths also fell. While the vaccine was held
\nresponsible for AEFIs in 58% of media-reported cases in 2013, the media pointed at pentavalent
\nvaccines as responsible in only 31% in 2014. The media analysis findings corroborate the
\neffectiveness of sensitizing the media.101
\n3.3. Post-licensure phase
\nWhile at the time of licensure there is enough evidence to conclude a positive risk-benefit balance,
\nuncertainty regarding some aspects of the risks remain (see \u00a73.2). When a product is launched, there is
\nhowever often little communication to the public about the knowledge gaps. Communications typically
\naddress the identified and sometimes potential risks, which were observed in clinical trials and have been
\nincluded in package labels, but communication regarding more theoretical potential risks and missing
\ninformation in the safety database is usually lacking. With a view to transparency, it has been established
\nthat messages to the public should honestly acknowledge uncertainties and that it is better to do this
\nproactively, rather than waiting for a debate in the scientific media to spill over into the general media.
\nDuring the post-licensure phase, the knowledge gaps get filled as safety data are obtained from
\nboth passive surveillance systems (i.e. spontaneous reporting) and active systems (i.e. active safety
\n100
\nMission Indradhanush: Centre asks all private TV, radio channels to promote government\u2019s immunisation programme The Financial
\nExpress PTI | New Delhi | Published: July 30, 2017. http:\/\/www.financialexpress.com\/india-news\/mission-indradhanush-centre-asks-
\nall-private-tv-radio-channels-to-promote-governments-immunisation-programme\/786539\/.
\n101
\nExample provided by Sonia Sarkar, UNICEF India.
\nChapter
\n3.
\nProduct
\nlife-cycle
\nmanagement
\napproach
\nto
\nvaccine
\nsafety
\nand
\ncommunication
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nsurveillance and epidemiological post-authorization safety studies),102 including those required by
\na risk management plan if applicable (see \u00a73.2). Safety signals103 identified from spontaneous
\nreporting systems often require subsequent epidemiological studies to quantify or to further
\ncharacterize the risk. However, most AEFIs detected from spontaneous reporting are so rare (i.e.
\n1\/10,000 – 1\/100,000) that follow-up epidemiological studies lack feasibility and statistical power
\nor require significant cooperation for collecting data from multiple database sources. Nevertheless,
\noften these types of rare events garner the majority of public attention in the media. Transparency
\nand clear communication throughout the evaluation of post-licensure safety signals is essential for
\nthe maintenance of public trust in the vaccine safety processes and provide for informed choice.
\nWith increasing post-licensure experience, knowledge of the safety profile of the vaccine increases,
\nand uncertainty decreases. With an acceptable safety profile and a successful communication
\nstrategy, many vaccines receive general public acceptance in the long run. However, safety signals
\nmay continue to arise which can for example be attributable to quality issues in the manufacturing
\nprocess, the introduction of new vaccines used in combination with older vaccines, or the expansion
\nof a vaccine indication to new populations. Communication strategies must be adaptable to new
\nneeds; simply repeating a previous, general message (i.e. \u201cthis vaccine is safe\u201d) is not adequate to
\nensure continued public trust.
\nExamples for how communication has been handled successfully in relation to vaccine safety
\nconcerns arising in the post-licensure phase are provided below (see Examples 3.3.1 and 3.3.2).
\nExample 3.3.1: Addressing the risk of febrile seizures with a serogroup
\nB\u00a0meningococcal\u00a0vaccines in the United Kingdom
\nA vaccine against meningococcal serotype B was licensed by the European Medicines
\nAgency (EMA) in 2013. Within the clinical trial program an increased rate of high fevers and
\nfebrile seizures in those infants who received this vaccine in combination with routine infant
\nimmunizations was noted. These risks were included in the package leaflet with a frequency
\nof > 1\/100 and < 1\/1000. Additionally, risk minimization measures to prevent fever and
\nsubsequent seizures were described in the package leaflet as follows: \u201cYour doctor or nurse
\nmay ask you to give your child medicines that lower fever at the time and after [the vaccine]
\nhas been given. This will help to reduce some of the side effects of [the vaccine].\u201d
\nThe UK was the primary country within the European Union which incorporated the meningococcal
\nB vaccine into its routine childhood vaccination program, and in September 2015 infants
\nstarted receiving the vaccination at 2 and 4 months of age in combination with pentavalent,
\npneumococcal, and rotavirus vaccines. Active measures were taken by Public Health England
\nto inform both healthcare professionals and parents about the need for use of prophylactic
\nparacetamol at the time of vaccination. Healthcare professionals were provided both a protocol
\ndocument as well as access to an instructional video that simulated a conversation between
\nprovider and parents. Parents were provided an information sheet at the time of discharge
\nafter delivery of a new baby as well as a patient information leaflet offering advice on the use
\nof paracetamol.
\n102
\nCouncil for International Organizations of Medical Sciences (CIOMS). CIOMS Guide to Active Vaccine Safety Surveillance (report of
\nthe CIOMS Working Group on Vaccine Safety). Geneva: CIOMS, 2017.
\n103
\nA signal is defined as information that arises from one or multiple sources (including observations and experiments), which suggests
\na new potentially causal association or a new aspect of a known association between an intervention and an event or set of related
\nevents, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action (see Council for International
\nOrganizations of Medical Sciences (CIOMS). Practical aspects of signal detection in pharmacovigilance. Geneva: CIOMS, 2010.). In
\nthe context of safety, a signal refers to an adverse event.
\nChapter
\n3.
\nProduct
\nlife-cycle
\nmanagement
\napproach
\nto
\nvaccine
\nsafety
\nand
\ncommunication
\n29
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nBelow is the information leaflet which is distributed to parents at the time of vaccination with
\nthe meningococcal B vaccine.104, 105
\n104
\nPublic Health England. MenB vaccine and paracetamol. Accessible at: https:\/\/www.gov.uk\/government\/publications\/menb-vaccine-
\nand-paracetamol.
\n105
\nExample provided by Rebecca Chandler, Uppsala Monitoring Centre (UMC), Sweden, with confirmation by email 14 August 2017 to
\nKarin Holm.
\nChapter
\n3.
\nProduct
\nlife-cycle
\nmanagement
\napproach
\nto
\nvaccine
\nsafety
\nand
\ncommunication
\n30
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nExample 3.3.2: Addressing the safety concern of narcolepsy for the H1N1
\npandemic influenza vaccine used in Sweden
\nA number of cases of narcolepsy in children were observed during the early post-licensure
\nphase of an H1N1 pandemic influenza vaccine used in late 2009. These cases were detected by
\npassive surveillance systems in both Finland and Sweden, countries in which mass immunization
\npractices had resulted in high vaccine uptake. Data for further characterisation and risk estimates
\nChapter
\n3.
\nProduct
\nlife-cycle
\nmanagement
\napproach
\nto
\nvaccine
\nsafety
\nand
\ncommunication
\n31
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nwere made available by active surveillance in the form of register-based studies designed in
\nresponse to the initial signal, and the assessment outcome was communicated to the public.
\nA review of the lessons learned from the H1N1 pandemic influenza vaccine -narcolepsy
\nexperience was organized by the Swedish regulatory authority at a special symposium on
\nnarcolepsy research related to this vaccine in November 2014, which brought together multiple
\nparties, including communication experts from the authority as well as representatives from
\nthe narcolepsy patient advocacy group.\u00a0
\nQuestions were asked of these representatives regarding the expected content, timing, process
\nand channels for communication. In addition, they were asked about their impressions of the
\navailability of experts at the authority to answer questions as well as how to best improve
\ndistribution of information to all parties in the future.\u00a0Overall, the representatives felt that
\ncommunication was of good quality but they would have liked clearer messages on the causal
\nrelationship rather than language including terms such as relative and absolute risks.\u00a0There was
\nalso confusion regarding the roles of experts from different public bodies, like the regulatory
\nauthority and the public health authority.\u00a0It was suggested that the regulatory authority should
\nhave corrected obviously misleading statements from opinion leaders in the public domain and
\nthe media through communication on its website as soon as possible.106, 107
\n106
\nFeltelius N, Persson I, Ahlqvist-Rastad J, et al. A coordinated cross-disciplinary research initiative to address an increased incidence
\nof narcolepsy following the 2009\u20132010 Pandemrix vaccination programme in Sweden. J Intern Med. 2015, 278: 335-353.
\n107
\nExample provided by Rebecca Chandler, Uppsala Monitoring Centre (UMC), Sweden, personal communication by email 8 March 2016.
\nChapter
\n3.
\nProduct
\nlife-cycle
\nmanagement
\napproach
\nto
\nvaccine
\nsafety
\nand
\ncommunication
\n32
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nCHAPTER 4.
\nVACCINE SAFETY COMMUNICATION PLANS
\n(VACSCPS)
\n4.1.
\nApplication of a strategic communication
\napproach to vaccine safety
\nStrategic thinking has increasingly been applied worldwide to health communication since the
\n1980s. The process of strategic health communication can be divided in five steps, the P-Process
\nof strategic health communication (Figure 4.1).
\nFigure 4.1: The P-Process of strategic health communication108
\nPARTICIPATION
\n1
\nInquire
\n2
\nDesign
\nStrategy
\n3
\nCreate
\n& Test
\n4
\nMobilize
\n& Monitor
\n5
\nEvaluate
\n& Evolve
\nCAPAC
\nI
\nT
\nY
\nT
\nH
\nE
\nO
\nR
\nY
\n\u2122
\nP stands for planning. It is essentially characterized by agreeing clear communication objectives as well
\nas a communication plan designed to achieve these objectives, ideally in terms of desired behaviour.109 A
\n108
\nThe Health Communication Capacity Collaborative. The P-Process: five steps to strategic communication. Baltimore, MD: Johns
\nHopkins Bloomberg School of Public Health Center for Communication Programs, 2013. Accessible at: http:\/\/www.thehealthcompass.
\norg\/sbcc-tools\/p-process or http:\/\/ccp.jhu.edu\/documents\/P_Process_5_Steps.pdf.
\n109
\nThe Health Communication Capacity Collaborative. The P-Process: five steps to strategic communication. Baltimore: Johns Hopkins
\nBloomberg School of Public Health Center for Communication Programs, 2013. Accessible at: http:\/\/www.thehealthcompass.org\/
\nsbcc-tools\/p-process.
\nStep 1: Inquiry
\nf
\nf Analysis of the situation
\nf
\nf Management considerations
\nStep 2: Design strategy
\nf
\nf Agreement on communication
\nobjectives
\nf
\nf Communication plan
\nStep 3: Create & Test
\nf
\nf Communication materials
\nStep 4: Mobilize & Monitor
\nf
\nf Implementation of plan
\nf
\nf Dissemination of
\ncommunication materials
\nStep 5: Evaluate & Evolve
\nf
\nf Evaluation if and how
\nobjectives have been
\nachieved
\nf
\nf Evaluation of impact
\nf
\nf Updated communication plan
\nChapter
\n4.
\nVaccine
\nsafety
\ncommunication
\nplans
\n(VacSCPs)
\n33
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\ncall has been made to apply this approach to communication about safety of medicines in the regulatory
\nenvironment,110, 111, 112 as well as to public information for immunization programmes.113 This strategic
\ncommunication approach can also be used to create vaccine safety communication plans (VacSCP).
\nHowever, communication strategies are not generic \u2018one-size-fits-all\u2019, but require tailored messages
\nand appropriate tools and channels to reach specific segments of the population, including hard-to-
\nreach populations.114 Research on vaccine hesitancy has also shown that sentiments are vaccine-type
\nspecific,115 and political and social situations can change, as can the overall public health situation.
\nFor example, the situation where a continuation of successful vaccination is required for disease
\nprevention, such as in the case of measles, differs from the situation of a public health emergency
\nduring a pandemic peak of a disease, and so the communication strategies will differ.
\nDifferent types of safety concerns will also require different responses, based on the evidence,
\nwhich may call for precaution, risk minimization measures or disseminating reassuring information.
\nCommunication strategies for vaccines are more likely to succeed if they are integrated at local level
\nwith the provision of other community health needs.116 Therefore the VacSCPs are to be designed
\nspecific to a vaccine-type and a given local situation at a specific point in time.
\nIt might not be feasible for an organization to immediately develop and maintain VacSCPs for each
\nvaccine, and a practical way is to create a generic plan suitable for the organization as a basis for
\ngenerating vaccine-specific plans according to the given situation and priorities, e.g. according to current
\npublic health needs and the public debate. Key considerations for managers are listed in Checklist 4.1.
\nChecklist 4.1: Management considerations for VacSCPs
\n5
\n5 Understand the situation and identify public health priorities
\n5
\n5 Identify stakeholders including their roles and responsibilities
\n5
\n5 Allocate budget
\n5
\n5 Agree timeline for the implementation of the VacSCP
\n5
\n5 Monitor the implementation of the VacSCP 117
\n110
\nBahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf. 2010,
\n33: 1065-1079.
\n111
\nFischhoff B, Brewer NT, Downs JS. Communicating risks and benefits: an evidence-based user\u2019s guide. Silver Spring, MD: US Food
\nand Drug Administration, 2009.
\n112
\nMinister of Health Canada. Strategic risk communications framework for Health Canada and the Public Health Agency of Canada.
\nOttawa: Minister of Health Canada, 2007. Accessible at: https:\/\/www.canada.ca\/en\/health-canada\/corporate\/about-health-canada\/
\nactivities-responsibilities\/risk-communications.html.
\n113
\nWaisbord S, Larson H. Why Invest in communication for immunization: evidence and lessons learned. Baltimore, New York: Health
\nCommunication Partnership based at Johns Hopkins Bloomberg School of Public Health\/Center for Communication Programs
\nand the United Nations Children\u2019s Fund (UNICEF), 2005. Accessible at: http:\/\/www.who.int\/immunization\/hpv\/communicate\/
\nwhy_invest_in_communication_for_immunization_unicef_healthcommunicationspartnership_path_usaid.pdf.
\n114
\nWaisbord S, Larson H. Why invest in communication for immunization: evidence and lessons learned. Baltimore, New York: Health
\nCommunication Partnership based at Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs
\nand the United Nations Children\u2019s Fund (UNICEF), 2005. Accessible at: http:\/\/www.who.int\/immunization\/hpv\/communicate\/
\nwhy_invest_in_communication_for_immunization_unicef_healthcommunicationspartnership_path_usaid.pdf.
\n115
\nKarafillakis E, Larson H, on behalf of the ADVANCE consortium. A systematic literature review of perceived risks of vaccines in
\nEuropean populations. Vaccine. 2017; 35: 4840-4850..
\n116
\nWaisbord S, Larson H., 2005.
\n117
\nBased on: O\u2019Sullivan GA, Yonkler JA, Morgan W, Merritt AP. A field guide to designing a health communication strategy. Baltimore,
\nMD: Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs: March 2003. Accessible at: http:\/\/
\nccp.jhu.edu\/documents\/A%20Field%20Guide%20to%20Designing%20Health%20Comm%20Strategy.pdf.
\nChapter
\n4.
\nVaccine
\nsafety
\ncommunication
\nplans
\n(VacSCPs)
\n34
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nAt the core of each VacSCP are its specific objectives in line with the overall aims of vaccine safety
\ncommunication (see \u00a72.2). According to the theory of the strategic approach to health communication,
\nall concerned stakeholders should ideally work together and agree on the communication objectives,
\nplan and materials. However, for a regulatory authority there is often little time to publish new data
\nand the news cannot be shared preferentially with some groups prior to the general public. Yet to
\nsome extent multistakeholder collaboration is practiced; for a number of years in some jurisdictions
\nregulatory authorities and the manufacturer have been agreeing on communication plans for
\ninterventions like direct healthcare professional communications (DHPCs) which have facilitated
\nclarity and planning.118, 119 There should also be agreement between regulatory authorities and
\nthe national immunization programmes, but it has to be understood that while the communication
\nmessages about the benefit-risk profile and safety of a vaccine should indeed be consistent,
\nthe communication plans will differ between these organizations, in order to align their objectives
\nwith the distinct mandates of each organization (i.e. marketing authorization of vaccine products and
\ninformation about the benefit-risk balance versus issuance of vaccination schedules and promotion
\nof vaccination for public health protection).
\n4.2.
\nDeveloping VacSCPs on the basis of a model
\ntemplate
\nVacSCPs may be developed by the professionals of the vaccine safety communication system of
\nthe regulatory body (see \u00a75.1) through a multistakeholder interaction (see \u00a74.1 and \u00a75.2), using
\nthe model template provided in Template 4.2.120 This VacSCP model template is based on the
\ncommunication plan template for vaccine safety events issued by WHO121 and has been enhanced
\nin line with the P-Process (see \u00a74.1) and its application to pharmacovigilance.122
\nThe effectiveness of a VacSCP will very much depend on the depth and width of the initial understanding
\nof the situation and the audiences (see \u00a72.1), and on the cooperation with stakeholders from the
\nVacSCP development phase and the whole communication cycle (see \u00a74.1). Guidance for understanding
\nand monitoring the situation (which both use the same methods) is provided in \u00a74.3.
\n118
\nFollowing informal use for a number of years, the following template has been published as part of EU-GVP: European Medicines
\nAgency (EMA) and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP) \u2013 Annex II \u2013 Templates:
\nCommunication Plan for Direct Healthcare Professional Communication (CP DHPC). London: EMA, 8 December 2015, Rev 1 12 October
\n2017. Accessible at:http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/regulation\/document_listing\/document_listing_000345.
\njsp&mid=WC0b01ac058058f32c.
\n119
\nHealth Canada. Issued Health Professional Communication – Dear Health Care Professional Letter document 3, 2008. http:\/\/www.
\nhc-sc.gc.ca\/dhp-mps\/pubs\/medeff\/_guide\/2008-risk-risques_comm_guid-dir\/index-eng.php#Document3.
\n120\tThe CIOMS VacSCP template is available in a downloadable form on the CIOMS website: www.cioms.ch.
\n121
\nWorld Health Organization Regional Office for Europe. Vaccine safety events: managing the communications response. Copenhagen:
\nWHO, 2013.
\n122
\nBahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies.Drug Saf. 2010,
\n33: 1065-1079.
\nChapter
\n4.
\nVaccine
\nsafety
\ncommunication
\nplans
\n(VacSCPs)
\n35
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nTemplate 4.2: Template for strategic vaccine type- and situation-specific vaccine
\nsafety communication plans (VacSCPs)
\nCIOMS Vaccine Safety Communication Plan (VacSCP)
\nVaccine product(s):
\nI. Situation and monitoring
\nVaccine safety:
\nEpidemiology:
\nPublic:
\nMonitoring of public KAP, concerns, rumours and information needs:
\nII. Communication objectives<\/p>\n

III. Strategic design of the communication intervention
\nTarget audiences:
\nChange model:
\nKey messages:
\nChapter
\n4.
\nVaccine
\nsafety
\ncommunication
\nplans
\n(VacSCPs)
\n36
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nCommunication tools and dissemination mechanisms in a mixed media approach:<\/p>\n

Interactions with journalists and community advocates\/activists:
\nTimetable:
\nTransparency provisions:
\nIV. Monitoring and evaluation<\/p>\n

A step-by-step guide to developing communication strategies for vaccine benefit-risk communication
\nwith practical examples has recently been developed in Europe and can also be helpful to follow
\nwhen developing VacSCPs (see Guidance Summary 4.2).123
\nGuidance Summary 4.2: Developing communication strategies on vaccine benefits
\nand risks
\nCommunication strategies for vaccine benefit-risk information aims at maintaining and improve
\npublic confidence in vaccination by demonstrating that decisions about vaccination are based
\non robust data and integrity. It is therefore important to communicate about the partners
\ngenerating and using data and their framework of collaboration, including their code of conduct
\nand quality management processes.124
\nThe development of such communication strategies should follow a practical stepwise approach:
\nf
\nf Step 1: define goals and objectives of the communication strategy;
\nf
\nf Step 2: map and engage with the various stakeholders;
\n123
\nAccelerated Development of Vaccine beNefit-risk Collaboration in Europe (ADVANCE). Developing Communication Strategies on
\nVaccine Benefits and Risks. ADVANCE, 2017. Available at: http:\/\/www.advance-vaccines.eu\/?page=publications&id=DELIVERABLES.
\n124
\nAccelerated Development of Vaccine beNefit-risk Collaboration in Europe (ADVANCE). Developing Communication Strategies on
\nVaccine Benefits and Risks. ADVANCE, 2017. Available at: http:\/\/www.advance-vaccines.eu\/?page=publications&id=DELIVERABLES.
\nChapter
\n4.
\nVaccine
\nsafety
\ncommunication
\nplans
\n(VacSCPs)
\n37
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nf
\nf Step 3: develop the communication content and core components of the strategy (e.g.
\nselected audiences, preferred channels) (step 3);
\nf
\nf Step 4: plan implementation and monitoring. (step 4).
\n4.3. Monitoring, evaluating and maintaining VacSCPs
\nThe VacSCP is a \u2018living document\u2019 to be updated to meet changing situations: New risks or safety
\ninformation may emerge at any time during the life-cycle of a vaccine (see Chapter 3), the epidemiology
\nof the disease to vaccinate against may change over time as well as the public KAP, concerns and
\ninformation needs. Among other things, the public debate overall may increase, decrease or change
\nin focus or stakeholders involved.
\nTherefore regular monitoring and evaluation activities are necessary to maintain the VacSCP and
\nadapt it at any time before, during and after a communication intervention. When deciding on revising
\nor designing future communication interventions and their timings, stakeholders need to take into
\naccount the risk of either over-communication and related the amplification of risk perception (see
\n\u00a72.2) or alert fatigue and associated decrease in risk perception and adherence to safe use advice.125
\nReal-time monitoring and regular evaluation, and subsequent adjustments are also essential for
\npreventing and managing crisis situations.
\nIn addition VacSCPs need to be updated with the learnings from the evaluation of the communication
\nintervention as part of the cyclic communication process (see \u00a74.1). The evaluation is a \u2018lessons
\nlearnt\u2019 exercise, describing the effectiveness of the communication intervention in relation to the
\nset objectives, or unintended effects, whether positive or negative. More specifically, the purpose of
\nevaluation is to identify further communication needs for maintaining or improving success, and to
\nadjust the VacSCP and communication interventions, building on the experience and evidence
\ngenerated by the evaluation.
\nEvaluating communication interventions and thereby the vaccine communication system (see Chapter\u00a05)
\nforms part of quality management of the system and is necessary for fulfilling accountability through
\nevidence. This should contribute to justifying resources for vaccine safety communication systems.
\nEvaluating is not an easy task, but it is essential for the sustainability of the systems and their
\noutcomes. However, rather than looking at evaluation from a sequential process perspective only,
\na broader view incorporates a continuous real-time monitoring of the implementation and impact of
\ncommunication interventions in addition to evaluations after an intervention.
\nThe methods and results of monitoring and evaluating of implementation, its effectiveness and other
\nimpact should be transparent and explained in their meaning and limitations. The main challenge
\nlies in finding methods and meaningful indicators, which ideally can, beyond describing change,
\nalso study causal relationships with the communication interventions and the factors which may
\ninfluence impact. For this, data pre- and post-intervention as well as on influences other than the
\nintervention should be collected. In any case one should ensure that mechanisms are in place for
\nsimple monitoring and feedback from all audiences. These may include measuring the dissemination
\nof messages through various media, KAP surveys, media monitoring and calculating vaccination
\nrates. The acronym KAP provides a reminder to conduct surveys comprehensively, to capture
\nknowledge, attitude and practice.126
\n125
\nAgency for Healthcare Quality and Research (AHQR), U.S.\u00a0Department of\u00a0Health\u00a0and Human\u00a0Services. Patient safety primer: alert
\nfatigue. Rockville, MD: AHQR, June 2017. Accessible at: https:\/\/psnet.ahrq.gov\/primers\/primer\/28\/alert-fatigue.
\n126
\nUnited Nations Children\u2019s Fund Regional Office for South Asia (UNICEF-ROSA). Building trust and responding to adverse events
\nfollowing immunisation in South Asia: using strategic communication. Kathmandu: UNICEF-ROSA, 2005.
\nChapter
\n4.
\nVaccine
\nsafety
\ncommunication
\nplans
\n(VacSCPs)
\n38
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nIn relation to knowledge, it should be measured how far an audience\u2019s awareness and understanding
\nof factual information has changed. Through attitude surveys, one can study the sentiments people
\nhave formed about something or somebody, and how these change over time (e.g. from hostile to
\nneutral or accepting of a proposal like vaccination or safe use advice, or to becoming increasingly
\nadverse and non-trusting). Practice relates to the behaviour, such as actual vaccination.
\n4.3.1
\nMonitoring of debates and sentiments in communities and
\nthe public
\nMonitoring of the public debates in the news and\/or social media can happen daily using a defined
\nlist of newspapers in paper or online news media outlets, social media search tools, or through
\nmaking use of a media intelligence service127 or academic research departments. The feasibility and
\nusefulness of media monitoring is illustrated with examples from the polio immunization program in
\nIsrael (see Example 4.3.1) and from the European Medicines Agency (EMA) for a safety assessment
\non HPV vaccines (see Example 4.3.2). A good example for monitoring Twitter for vaccine debates in
\nmultiple languages can be found in the literature.128 One can also monitor media queries and questions
\nfrom the public to the organization. Regular exchange with community and opinion leaders can also
\nprovide important insights, and supplement quantitative data (i.e. obtained through measurement)
\nwith regard to possible causal relationships and factors influencing communication effectiveness.
\nWhere measurements are difficult, the observations from community and opinion leaders able to
\nprovide feedback in comprehensive, unbiased manner are even more valuable.
\n127
\nThis may be a commercial service, but non-commercial tools are also available for own use, such as MEDISYS, provided by the
\nEuropean Commission under: https:\/\/ec.europa.eu\/jrc\/en\/scientific-tool\/medical-information-system.
\n128
\nBecker BF, Larson HJ, Bonhoeffer J, van Mulligen EM, Sturkenboom MC. Evaluation of a multinational, multilingual vaccine debate
\non Twitter. Vaccine. 2016; 34: 6166-6171.
\nChapter
\n4.
\nVaccine
\nsafety
\ncommunication
\nplans
\n(VacSCPs)
\n39
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nExample 4.3.1: Social media monitoring during polio supplementary immunization
\nactivities (SIA) in Israel
\nIn response to the reintroduction of wild poliovirus, the Israeli Ministry of Health, in 2013,
\nconducted a large-scale media campaign with successful media monitoring. In that year, a wild
\npoliovirus was detected in routine environmental surveillance in a sewage system in the Southern
\npart of Israel. The population immunity was high, with vaccination coverage with inactivated
\npolio vaccine (IPV) above 95% and without detection of actual polio-cases. Still, it was decided
\nto implement supplementary immunization activities (SIA) with oral and injected polio vaccines.
\nInitially, this decision caused resistance in some groups. However, through concerted effort
\nand a comprehensive communication strategy the campaign became a success. A key element
\ncontributing to this success was a sophisticated system of media monitoring to understand
\npublic opinion and respond to concerns. As part of this effort, health authorities via social media
\nbecame aware of a planned anti-vaccination protest demonstration and were able to mobilize
\npolio victims to address the public at this demonstration. An indication of the success of the
\ncampaign is that at the beginning only 55% of parents said they would bring their children for
\nsupplementary immunization, but a few months later, after the communication interventions,
\n75% of the targeted children had been vaccinated, i.e. more than 900,000 out of 1.2 million.129
\nExample 4.3.2: Utility of online news media monitoring for prepared
\ncommunicating of the outcome of a safety assessment for HPV vaccines at the
\nEuropean Medicines Agency (EMA)
\nPublic debate regularly centers around the benefit-risk of vaccines often taking place in
\ntraditional and social media. To address this trend, the European Medicines Agency (EMA)
\nwanted to examine the utility of media monitoring and how it could be useful for regulatory
\nbodies. In 2015 EMA conducted a media monitoring study concerning human papillomavirus
\n(HPV) vaccines over the period of time during which a procedure was instigated to investigate
\nthe potential causality of two suspected adverse reactions reported to the authorities: complex
\nregional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS).
\nProspective real-time monitoring of worldwide online news was undertaken from September to
\nDecember 2015 with inductive content analysis. More than 4000 news items – originals and
\nre-posted ones – were collected, containing personal stories, scientific and policy\/process-
\nrelated topics. Explicit and implicit concerns voiced in the news media and some linked blogs
\nwere identified, including those raised due to lack of knowledge or anticipated once more
\ninformation would be published, generating \u2018derived questions\u2019.
\nRather than describing these concerns and information needs in factual style, those collected
\nuntil 24 October were \u2018translated\u2019 into scientific or regulatory language and formulated as
\n50 questions (which could be categorized into 12 themes). The questions related to a wide
\nrange of topics, such as CRPS and POTS case definitions, underreporting of suspected
\nadverse reactions, trustworthiness of data as well as the standards and code of conducts of
\nregulatory bodies.
\n129
\nKaliner E, Moran-Gilad J, Grotto I, et al. Silent reintroduction of wild-type poliovirus to Israel, 2013: risk communication challenges in
\nan argumentative atmosphere. Euro Surveill. 2014, 19: 20703.
\nChapter
\n4.
\nVaccine
\nsafety
\ncommunication
\nplans
\n(VacSCPs)
\n40
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nThe \u2018derived questions\u2019 were provided to assessors and medical writers\/media officers at
\nthe EMA and the EU member states for use in real life and preparing the communication of
\nthe outcome of the assessment on 5 November. It was demonstrated that providing media
\nmonitoring findings to assessors and medical writers\/media officers resulted in: (1) confirming
\nthat public concerns regarding CRPS and POTS would be covered by the assessment; (2)
\nmeeting specific information needs proactively in the public statement; (3) predicting all queries
\nfrom journalists received at the press conference on 5 November and in writing thereafter;
\nand (4) altering the tone of the public statement with respectful acknowledgement of the health
\nstatus of CRSP and POTS patients.
\nThe study demonstrated the utility of media monitoring for regulatory bodies to support
\ncommunication proactivity and preparedness. Derived questions seem to be a suitable
\nmethod since regulators normally formulate situations as research questions. Presenting
\nmedia monitoring results in the scientific-regulatory environment and formulating the media
\ncontent as questions were both novel approaches that yielded useful information. The study
\nsuggests that media monitoring could form part of regular surveillance for medicines of high
\npublic interest.130
\n130
\nBahri P, Fogd J, Morales D, Kurz X, ADVANCE consortium. Application of real-time global media monitoring and \u2018derived questions\u2019
\nfor enhancing communication by regulatory bodies: the case of human papillomavirus vaccines. BMC Medicine. 2017 May 2, 15:91.
\nChapter
\n4.
\nVaccine
\nsafety
\ncommunication
\nplans
\n(VacSCPs)
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\nCHAPTER 5.
\nVACCINE SAFETY COMMUNICATION
\nSYSTEMS
\n5.1.
\nFunctions of vaccine safety communication
\nsystems
\nGenerally, systems are understood as consisting of structures and processes to fulfil certain
\nobjectives; and in order to enable preparing and implementing planned communication, a vaccine
\nsafety communication system consists of certain key functions (see Checklist 5.1). Depending on
\nthe structure of the regulatory authority, all functions might form one dedicated department or
\nthere might be a split between planning, implementing and evaluating communication interventions.
\nTaking into account local resources, opportunities and priorities, an organization may choose which
\nfunctions to build up first and to which extent, so that a tailored system can be built up over time.
\nChecklist 5.1: Key functions of vaccine safety communication systems
\n5
\n5 Development of strategic vaccine-type and situation-specific vaccine safety communication
\nplans (VacSCPs)
\n5
\n5 Establishment and maintenance of multistakeholder networks
\n5
\n5 Collaboration at local, country, regional and international level
\n5
\n5 Monitoring of vaccine knowledge, attitudes, practices (KAP) and related concerns, rumours
\nand information needs
\n5
\n5 Interaction with the media through a dedicated spokesperson
\n5
\n5 Development of communication messages and materials
\n5
\n5 Implementation of communication interventions
\n5
\n5 Evaluation of communication interventions
\n5
\n5 Management of vaccine safety crisis
\n5.2. Multistakeholder network
\nVaccine safety communication consists of complex processes of listening and messaging between
\nthose with responsibilities for vaccine safety as well as institutional and public stakeholders at local,
\ncountry, regional and international level (see Table 5.2.1).
\nChapter
\n5.
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\nsafety
\ncommunication
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\nTable 5.2.1: Main stakeholders involved in the vaccine safety communication
\nprocess
\nf
\nf Regulatory authorities
\nf
\nf Public health authorities
\nf
\nf National immunization committees
\nf
\nf National advisory committees on adverse events following immunization
\nf
\nf Health technology assessment bodies
\nf
\nf Ministries of health
\nf
\nf Local and national politicians
\nf
\nf Vaccine manufacturers
\nf
\nf Representatives of vaccine target populations, vaccinees, parents, carers and the community
\n(villages, civil society), including e.g. women\u2019s groups, anti-vaccine groups, citizen watchdogs
\nf
\nf Religious and community\/public opinion leaders, including e.g. teachers
\nf
\nf Representatives from healthcare professionals in public and private healthcare, traditional and
\nalternative healer communities, healthcare professional associations, learned societies
\nf
\nf Media representatives and journalists
\nf
\nf Non-governmental organizations
\nf
\nf Donors and procurement agencies
\nf
\nf Technical development agencies
\nf
\nf Multilateral agencies, e.g. World Health Organization (WHO) and its Global Advisory Committee
\non Vaccine Safety (GACVS), UNICEF
\nAny stakeholder group or individual may take particular roles in shaping public and personal sentiments
\nand impact on knowledge, attitude and behaviour of individuals. Opinion leaders may be healthcare,
\ncommunity and religious leaders, teachers, journalists, or come from a trusted governmental or
\nnon-governmental organization or interest groups like anti-vaccine groups, women\u2019s groups or citizen
\nwatchdog groups. An opinion leader can come from inside or outside a concerned community or
\ncountry. Opinion leaders may specifically act as intermediaries between the authorities and the public.
\nCommunication in the public domain impacts on interpersonal communication between individuals in
\nhealthcare settings as it occurs (e.g. when discussing informed consent, proposed vaccination of
\nchildren or suspected harm due to a vaccine). Individuals often trust their physician, nurse, midwife,
\npharmacist and\/or other traditional\/alternative healthcare professionals or sources.
\nAn essential function of a vaccine safety communication system therefore is the stakeholder and
\ncommunity network, which needs to be established over time and be carefully maintained (see
\nChecklist 5.2) for a number of important objectives (see Table 5.2.2). Overall, collaboration with
\nthe network should allow for multiple perspectives on vaccines and approaches to solve issues,
\nmaking use of communication for increasing common understanding, disseminating the evidence
\nbase and achieving agreements. Understanding of the complexity of the network may be facilitated
\nby thinking about and mapping interactions according the social ecological model (SEM)(see \u00a72.1).
\nChecklist 5.2: Establishing and maintaining national stakeholder networks
\n5
\n5 Set objectives of interactions
\n5
\n5 Build capacity and infrastructure for public dialogue and deliberation
\n5
\n5 Map majority and minority stakeholders, their roles and how to approach them, including
\nin case of vaccine or communication crisis
\nChapter
\n5.
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\nsafety
\ncommunication
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\n5
\n5 Create a national media map
\n5
\n5 Define mechanisms and policies for interactions
\n5
\n5 Establish a code of conduct for governmental organizations and other policies to avoid
\nlobbying, conflict of interests and bias and keep transparency
\n5
\n5 Demand, as a governmental organization, transparency from all stakeholders of information
\nsources, finances and interests
\n5
\n5 Define a policy for what are appropriate collaborations from vaccine manufacturers
\n5
\n5 Create a public calendar of interactions, e.g. newsletters and events
\n5
\n5 Publish outcomes of interactions and express thanks for the contributions
\n5
\n5 Offer subscriptions and services to ask questions and provide feedback
\nTable 5.2.2: Purposes of multistakeholder interactions
\nf
\nf Listening to current understanding, concerns and information needs of the public regarding
\nvaccines in general and in relation to specific issues;
\nf
\nf Involvement of audiences in the development of VacSCPs and communication interventions,
\nincluding usability testing;
\nf
\nf Provision of collaboration, e.g. for defining and agreeing messages about vaccine risks\/
\nsafety, participation of community(ies) in consultations undertaken by regulatory authorities and
\ndeliberation processes;
\nf
\nf Interactions with the media; and
\nf
\nf Demonstrating trustworthiness and trust-building.
\nThe institutional stakeholders at local and country level include those in charge of vaccine licensure,
\nhealthcare payments and reimbursement, procurement, supply management, immunization policy-
\nmaking and immunization program management. Also, stakeholders along the vaccine supply chains
\nmay need to communicate at population level, as they have the responsibility for selecting high quality
\nsafe vaccines and distributing them safely. Vaccine manufacturers are an institutional stakeholder
\ntoo, and may be from inside or outside the country. Each of the institutions will have their assigned
\nresponsibility in the overall vaccine safety process within the country and consequently have a need
\nfor their own vaccine safety communication systems. Communication between these institutional
\nparties may or may not happen in the public domain.
\nMechanisms need to be in place for cooperation between these organizations, so that communication
\nmessages about the safety of specific vaccines are consistent, despite that communication objectives
\nwill differ between organizations in accordance with their legal mandate. For example, public health
\nagencies have to primarily communicate about the immunization programmes, while regulatory
\nauthorities communicate about the benefit-risk profiles of individual vaccine products. Despite
\nclose collaboration, regulatory authorities and other public bodies must keep their independence.
\nLikewise the legal responsibilities of all parties in vaccine safety have to be respected as well as
\nthe independence of the media.
\nPublic stakeholders include the vaccine target populations, their families, healthcare professionals,
\nthe communities, interest groups and the media. The media are comprised of both traditional and
\nevolving print, paper, mail, poster, television, radio, electronic and web-based news and social media,
\nsuch as Facebook and Twitter. Interactions with the media should provide journalists, proactively
\nand in responsively, with accurate information about the safety profile and safe use of vaccines,
\nChapter
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nwithout trying to influence them in a way that would, truly or be perceived as, trying to jeopardize
\nthe independence and freedom of the media.
\nGood interaction with stakeholders can prevent a crisis situation, as shown in the following Example 5.2.
\nExample 5.2: Managing an adverse event following immunization with HPV vaccine
\nin the United Kingdom
\nIn September 2008, the Department of Health (DH) of the United Kingdom (UK) launched their
\nnational programme to vaccinate girls aged 12-13 against human papillomavirus (HPV). At the
\nsame time, a two-year catch-up campaign began to vaccinate older girls under the age of 18
\nyears. The programme has largely been delivered through secondary schools. Three doses
\nof HPV vaccine are given over a six-month period. The first year of the programme achieved
\nhigh vaccination coverage with all three doses (81% of the girls aged 12-13 years).131 More
\nthan 1.4 million doses had been given since the vaccination programme started.
\nOn 28 September 2009, a 14-year old girl died shortly after receiving an HPV vaccination
\nat her school in Coventry, UK. When a serious adverse event following immunization (AEFI)
\noccurs, it is important that accurate information is communicated in the media and that the
\nfacts of the event do not become distorted. Through proper handling of the media response
\nto AEFIs, health officials can avoid loss of public confidence in vaccination. The following
\ntable summarizes the events of 2008 and how the respective authorities responded as the
\nevents unfolded:
\nDay 1 – September 28, 2009
\nStudent dies 75 minutes
\nafter HPV vaccination.
\nKnown medical facts:
\nf
\nf 10:45 a 14-year old girl receives an HPV vaccination along
\nwith other girls in her school.
\nf
\nf At about 11:30 she collapses at school.
\nf
\nf By noon she has died at the hospital.
\nf
\nf There was no evidence of an acute allergic reaction.
\nResponses
\nLocal health department
\n(NHS Coventry)
\n1.\t Informed the UK DH immunization director.
\n2.\t Informed the national drug regulator (MHRA) of an adverse
\nevent through the yellow card system.
\n3.\t Issued a brief press statement including facts of death,
\nsympathies to family and friends, and announcing that
\nan urgent and full investigation was being conducted.
\nStatement also warned that:
\n\u201cNo link can be made between the death and the vaccine until
\nall the facts are known and a post mortem takes place.\u201d
\n131\t United Kingdom Department of Health and Health Protection Agency. Annual HPV vaccine uptake in England
\n2008\/09.
\nChapter
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\ncommunication
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nNational health department
\n(UK DH)
\n1.\t Quarantined vaccine batch as a precautionary measure
\nand alerted local Directors of Public Health, Immunisation
\nCoordinators and General Practitioners.
\n2.\t Confirmed that MHRA had received yellow card and began
\ninvestigation.
\n3.\t Issued press statement with facts of death and information
\non the vaccination programme.
\n4.\t Decided not to suspend vaccination programme during the
\ninvestigation.
\n5.\t Decided not to assign a government spokesperson for
\ninterview requests.
\n6.\t Decided not to make any further statements until new
\ninformation was available.
\nSchool misinforms parents Sent a letter to parents that said:
\n\u201cAn unfortunate incident occurred and one of the girls suffered
\na rare, but extreme reaction to the vaccine.\u201d
\nHowever, at this point the cause of death was unknown and
\nit was impossible to say whether this tragedy was caused by
\na reaction to the vaccine. Even though the school corrected
\nthis information on their website later that evening, it caused
\nconfusion and concern among the parents and media.
\nHigh media interest Local and international evening broadcast news reports girl\u2019s
\ndeath shortly after receiving HPV vaccination.
\nHigh interest from media in the story.
\nDay 2 – September 29
\nResponses
\nPolitical opposition
\ncriticizes government
\nAn opposition politician noted that the government had chosen
\nthe vaccine product used and suggested that the competitor\u2019s
\nvaccine could have been a safer option. He called for safety
\ndata to be published.
\nManufacturer recalls
\nvaccine batch
\nManufacturer voluntarily recalled vaccine batch.
\nNational (UK DH) waits for
\nnew information
\nDecided not to respond to political opposition claims and
\nfollowed their policy against making additional statements until
\nnew information was available.
\nThere was concern it could be days before the autopsy results
\nwere known. Internal intelligence allowed communications
\noffers to brief journalists with whom they had a relationship to
\nbe cautious about any speculation that the vaccine caused the
\ndeath until more information was known.
\nPreliminary post-mortem
\nresults
\nIn the evening, preliminary autopsy results found that the girl\u2019s
\ndeath was due to a rare serious underlying medical condition
\nand that the vaccination did not play a role in her death.
\nChapter
\n5.
\nVaccine
\nsafety
\ncommunication
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nUK DH contacts media At about 9:30 PM UK DH communication officers urgently
\nbegan contacting TV news teams, followed by the Press
\nAssociation, and newspapers in time for the 10 PM UK
\ntelevision news programmes, and to reverse any negative
\nheadlines in the next day\u2019s papers.
\nHigh media interest Interest in story remains high.
\nEvening broadcast news (10 PM) reported preliminary post-
\nmortem results.
\nDay 3 – September 30
\nResponses
\nUK National Institute for
\nBiological Standards and
\nControl
\nPreliminary testing of vaccine batch found it to fully conform to
\nall safety standards.
\nNational (UK DH) Informed school services to continue immunizing with HPV
\nvaccine.
\nOffered government spokespeople for interviews with the
\nmedia, but media was no longer interested.
\nSecondary story
\nemerges\u2026.
\nLegal firm alerted the press that it was representing the
\nfamilies of 10 English girls who, they claim, had been
\nadversely affected by HPV vaccination. It is the basis for two
\nfeatures, one in the Daily Mail, the other in Sunday Times.
\nMedia Most morning newspapers did not reflect preliminary post-
\nmortem results.
\nPreliminary post-mortem results announced during the day.
\nStory begins to die out in the mainstream press.
\nDay 4 – October 1
\nResponses
\nPost-mortem results
\npublished
\nPreliminary post-mortem results are published.
\nNational (UK DH) reaches
\nout to media
\nOffered government spokespeople for interviews with the
\nmedia, but there is little interest from the media.
\nMedia coverage drops Reports on published post-mortem results.
\nStory continues to die out in the mainstream press.
\nThe death of the student shortly following HPV vaccination instigated widespread media attention,
\nsometimes with erroneous, misleading, confusing headlines, and provoked public concern
\nabout the vaccine. Some media stories created a false assumption that there was a true risk
\nwith the vaccine. Some stories created the impression that the vaccination programme was
\nin chaos, and by implication that the government had lost control of the situation.
\nChapter
\n5.
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\nsafety
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nThe most vivid example of inaccurate reporting was published in the weekly Sunday Express
\non 4 October (\u201cJab as deadly as the cancer\u201d), eight days after the student\u2019s death and long
\nafter the vaccine was cleared from playing a role in the death. Independent news media plays
\na pivotal role shaping public perception of vaccination programmes. In this case, the media
\nwas most interested in the story when there were unanswered questions about the safety of
\nthe vaccine. These kinds of questions can give rise to rumours and false information. It is
\ntherefore important for vaccine safety communicators to get in front of the story to frame the
\nquestions in the media and provide accurate answers rather than be reactive because chasing
\nand countering rumours and misinformation is difficult and often not entirely successful.
\nThe HPV vaccination programme in the UK was not at any point in time in jeopardy. In Coventry,
\nthe local National Health Service (NHS) did not suspend its vaccination programme, but rescheduled
\nclinics for Tuesday and Wednesday to give staff the chance to be fully briefed to answer public
\nenquiries. In some areas vaccination sessions were temporarily halted because their vaccine
\nsupply was from the batch that was quarantined.
\nThis case never reached crisis level due to the immediate and appropriate management of
\nthe situation by the UK DH.
\nThe following contributed in particular to this effective management:
\nf
\nf Immediate coordination of communications with school officials;
\nf
\nf Issuing of a preliminary statement within a few hours;
\nf
\nf Close collaboration between government communication and immunization departments;
\nf
\nf Being careful about making public comments when not yet fully informed and confirming
\navailable facts before making any public statements;
\nf
\nf Communication with receptive journalists with whom a relationship already exists;
\nf
\nf Keeping politics out of the story;
\nf
\nf Being sensitive (while the administration of a vaccine shortly before this girl died was a
\ncoincidence, all correspondence needed to be sensitive to the fact that this was a local
\ntragedy).
\nImmediate management requires being prepared, especially regarding the following:
\nf
\nf Knowing the baseline incidence of possible serious adverse events;
\nf
\nf Training vaccination personnel at all levels to respond adequately;
\nf
\nf Prepare a plan to react to a crisis when it occurs, including immediate reporting of AEFIs
\nto the national agency responsible for pharmacovigilance.
\nWith a view to understand the impact of the student\u2019s death on the public perception of HPV
\nvaccines and thereby also evaluate the impact of the communication during the investigations,
\nthe UK DH designed a survey that would allow them to compare current public perceptions
\nwith those existing before the programme began. They could do so because the UK DH had
\nconducted surveys, beginning three years before the introduction of HPV vaccination, as follows:
\nf
\nf 2005. Initial qualitative research conducted among parents about their attitudes and
\nawareness of HPV and HPV vaccine.
\nf
\nf 2007. Just over a year before the launch of the programme, surveys were carried out
\namong students, parents and health professionals:
\nChapter
\n5.
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nf
\nf one survey measured the opinions of HPV vaccination among parents of 8- 9 years-old girls;
\n\u2014
\n\u2014 this survey was repeated among 12-years-old girls and their parents;
\n\u2014
\n\u2014 this information was intended to determine the most acceptable age to target vaccination,
\nas it was important programmatically because it shifted the implementation from
\nprimary to secondary school environments;
\n\u2014
\n\u2014 Some of these surveys provided \u201cpre-campaign\u201d or \u201cbaseline\u201d data to be used to
\nmonitor changes in attitudes and awareness of HPV vaccine.
\nf
\nf 2008. Once the vaccination programme was underway \u2013 the routine programme began
\nas well as the catch-up campaign \u2013 surveys were regularly carried out to track progress
\nand detect changes in the programme.
\nf
\nf 2009-10. Surveys were regularly carried out to track progress and detect changes in
\nthe programme, while the routine programme continued and the catch-up campaign was
\nconcluded.
\nFurther in 2007 a survey measured public perception of the vaccine by asking mothers and
\ndaughters to read an information card on HPV and the vaccination programme. They were then
\nasked how favourable they felt towards the vaccination. In that survey at least four out of five
\nrespondents (80%) in each group said they were \u201cvery\u201d or \u201cfairly\u201d favourable of the HPV vaccine.
\nAfter the death of the student, the UK HD conducted a new survey, again asking mothers and
\ndaughters to read an information card on HPV and the vaccination programme and how favourable
\nthey felt towards the vaccine. There were no significant changes in the high levels of favourability
\ntoward the HPV vaccine after the student\u2019s death. At least four out of five respondents (80%) in
\neach group said they were \u201cvery\u201d or \u201cfairly\u201d favourable of the HPV vaccine.
\nThe awareness that a student had died shortly after receiving HPV vaccination was assessed by
\nan additional survey.\u00a0Mothers and daughters were asked what they had recently seen or heard
\nin the media about HPV. Between two and three in ten mentioned the event in their responses
\n(i.e. they demonstrated spontaneous awareness). If the student death was not mentioned at
\nthis stage, respondents were asked directly if they were aware of the incident \u2013 this question
\nmeasured prompted awareness. Including prompted responses, over 80% of mothers and
\n70% of daughters were aware of the case. The remaining mothers and daughters were \u201cnot
\naware\u201d of the incident.
\nThose who had reported being aware of the death of the student were asked to describe how
\nconcerned they had initially felt at the time the event occurred. At least seven in ten of respondents
\nwere initially concerned about the vaccine. When mothers and daughters were asked how
\nconcerned they currently felt, now that it was clear that the girl\u2019s death was not linked to the HPV
\nvaccination, most mothers and daughters were no longer concerned about the HPV vaccine.
\nToday, the UK regularly monitors public opinion on vaccination and trust in health authorities
\nthrough both quantitative and qualitative research. This means that they are able to detect
\nchanges in public trust or opinions on vaccination and respond to them, long before they
\ncould develop into a crisis. 132
\n132
\nWorld Health Organization (WHO). Managing an adverse event following immunization: an interactive case study. Geneva: WHO,
\n2011. Accessible at: http:\/\/vaccine-safety-training.org\/c-resources.html.
\nChapter
\n5.
\nVaccine
\nsafety
\ncommunication
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\n5.3.
\nRegional and international awareness and
\ncollaboration
\nImmunization is a matter of global public health and news and rumours may travel quickly. For these
\nreasons, a vaccine safety communication system needs to maintain awareness of the vaccine safety-
\nrelated discussions around the globe that may have an impact in one\u2019s own country. On particular
\nissues, an adverse event reported in one country may have implications for other places using the
\nsame product or batch of a particular vaccine. Optimal international communication on vaccine
\nsafety issues can be enhanced when those national authorities in charge of the national immunization
\nprogram or assessment and licensure of vaccines, that are the main government entities responsible
\nfor vaccine safety, are familiar with international parties and experts who can provide them with
\ninformation, independent advice or information to rely upon for key messages. In Figure 5.3 the
\nrelationships between the main parties for global collaboration are presented. This schematic
\nhighlights the need for the stakeholder network (see \u00a75.2.) not only to cover the local or country
\nlevel, but also to enable regional and international collaboration.
\nFigure 5.3: Relationships of parties in global vaccine safety
\nNational AEFI surveillance,
\ninvestigation and response*
\nImmunization
\nprogramme
\nAEFI review
\ncommittee
\nPharmaco –
\nvigilance
\nexperts
\nRegulatory
\nauthority
\nGlobal and regional analysis and response
\nProduct monitoring
\nGlobal signal
\ndetection and
\nevaluation
\nGlobal capacity
\nbuilding and
\nharmonized tools
\nMultilateral
\norganizations
\nVaccine
\nmanufacturers
\nGlobal Advisory Committee
\non Vaccine Safety (GACVS)
\nOther global or regional
\nadvisory bodies
\nTechnical agencies
\nDonors
\nInternational
\nnetworks
\nProgramme for
\nInternational Drug
\nMonitoring
\nVaccine Safety Net
\nLicensing authorities
\nin countries of
\nmanufacture
\nProcurement
\nagencies
\n* Several entities that participate in the national primary health care system usually contribute to vaccine pharmacovigilance.
\nSource: World Health Organization. Adapted for CIOMS Guide to Active Vaccine Safety Surveillance, 2017.133
\n133
\nWorld Health Organization. Adapted for CIOMS Guide to Active Vaccine Safety Surveillance (2017) from graphic WHO entitled,
\n\u201cComponents of a 21st Century global vaccine safety monitoring, investigation, and response system.\u201d Module 5: Vaccine safety
\ninstitutions and mechanisms Vaccine safety basics learning manual, www.vaccine-safety-training.org.
\nChapter
\n5.
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\nsafety
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\nAt international level, a number of stakeholders are specifically important for LMICs: The Global
\nAdvisory Committee on Vaccine Safety (GACVS) provides independent, authoritative, scientific advice
\nto WHO on vaccine safety issues of global or regional concerns with the potential to affect in the
\nshort or long term national immunization programmes. Its assessments of vaccine safety issues are
\npublicly available and statements are occasionally produced when urgent concerns are identified.134
\nWHO Strategic Advisory Group of Experts (SAGE) develops recommendations for vaccine utilization
\nbased on a risk-benefit analysis informed by GACVS assessments. WHO, UNICEF and their country
\noffices and other partner technical agencies and donors are engaged in the Global Vaccine Safety
\nInitiative (GVSI). Donors are important parties as they interact with immunization policy decision-
\nmakers, can prioritize resources, and provide access to non-state and private sector parties.
\nParticularly for supporting communication a country level, WHO has created the Vaccine Safety Net
\n(VSN) 135 as a network of more than forty reputable governmental, professional associations and
\nacademic websites (with a combined reach estimated at millions of visits each year) that provide
\nvaccine safety information in various languages. Each website has been evaluated by WHO and after
\nhaving met criteria for good information practices was added to the VSN list of reliable websites.
\nThe VSN aims to address the variable reliability of information available from the worldwide web. This is
\nparticularly relevant in the area of vaccine safety, where a high number of websites provide incomplete
\nor misleading information, including unfounded rumours or fraudulent research. This can lead to
\nundue fears und uncertainties among the general public and undermine immunization programmes.
\nThe Uppsala Monitoring Centre136 maintains for the WHO Programme for International Drug Monitoring,
\na global data base of individual case safety reports, called VigiBase, which can be accessed by
\nmember countries of the programme in order to verify if similar issues have been identified elsewhere
\nwith a particular vaccine product.
\n134
\nWorld Health Organization (WHO). Global Advisory Committee on Vaccine Safety (GACVS) [website]. Accessible at: http:\/\/www.who.
\nint\/vaccine_safety\/initiative\/communication\/network\/_gacvs\/en\/.
\n135
\nWorld Health Organization (WHO). Vaccine safety net. Accessible at: http:\/\/www.who.int\/vaccine_safety\/initiative\/communication\/
\nnetwork\/vaccine_safety_websites\/en\/.
\n136
\nUppsala Monitoring Centre https:\/\/www.who-umc.org\/
\nChapter
\n5.
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\nsafety
\ncommunication
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\nCHAPTER 6.
\nCAPACITY BUILDING FOR VACCINE SAFETY
\nCOMMUNICATION SYSTEMS
\n6.1. Skills and capacity requirements
\nPeople working on vaccine safety communication require a set of critical skills and capacities
\n(see Checklist 6.1). The communication system needs to support the application of these skills
\nwith appropriate structures and processes within the organization. More than one person may be
\nrequired to cover all what is required, and a team will be needed in large organizations. In addition
\nto technical communication skills, the overall mind set and empathy as well as emotional and
\nrelationship intelligence are specifically crucial for anybody working vaccine safety communication,
\nrequiring qualities of imagination, openness and appropriate behaviours. Empathy is the ability to
\nunderstand and share the feelings of another;137 this must be based on knowledge of what individuals
\nor groups are thinking and feeling. No communication or information, however creative, colourful or
\nmodern, will reach and influence audiences unless this essential understanding and connection is
\nmade. The connection is supported through research, engagement and dialogue with the audiences.
\nChecklist 6.1: Skills and capacity requirements for vaccine safety communication
\n5
\n5 Alert, listening, agile and responsive mind set
\n5
\n5 Sensitive, contextualizing, far-seeing and proactive approach
\n5
\n5 Understanding of the communication sciences and operations for an overall professional
\napproach
\n5
\n5 Ability to develop and apply quality management to communication processes
\n5
\n5 Decision-making and implementation abilities
\n5
\n5 Ability to establish and maintain strong, honest and trusted networks at community, expert
\nand policy levels
\n5
\n5 Knowledge and understanding of the medical and scientific issues as well as the social,
\npolitical, economic, religious and cultural issues, and of how these issues affect risk
\nperceptions and vaccination decisions in different groups
\n5
\n5 Skills in reviewing and interpreting media debates
\n5
\n5 Empathy and the ability to tailor messages meeting the audiences\u2019 differential needs in
\nterms of information content, presentation and tone,
\n5
\n5 Ability to act in ways that show the audiences that they are understood and taken seriously
\n5
\n5 Ability to communicate in a clear, honest and transparent manner at eye level with the
\npeople and communities addressed
\n137\tOxford Dictionary. Accessible at https:\/\/en.oxforddictionaries.com\/definition\/empathy, Accessed on 10 November 2016.
\nChapter
\n6.
\nCapacity
\nbuilding
\nfor
\nvaccine
\nsafety
\ncommunication
\nsystems
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\n5
\n5 Knowledge of information technology, keeping up with developments of new and social
\nmedia and \u2018big data\u2019 in terms of technology and their use by the different audiences
\n5
\n5 Ability to prevent and manage crisis situations
\n5
\n5 Ability to evaluate and judge the effectiveness of communication interventions with a view
\nto continuous improvement
\nSource: Bruce Hugman, Consultant, Uppsala Monitoring Centre.138
\n6.2. Contents and objectives of training
\nThe structure of training events for vaccine safety communication systems can be based on the
\nmodular curriculum for teaching pharmacovigilance, issued jointly by WHO and the International
\nSociety of Pharmacovigilance (ISoP), which contains a module on communication. This module
\nrecommends teaching content in four areas that can be filled with vaccine-specific training content.
\n(see Table 6.2).139 Training courses should also be adapted to different and emerging vaccine safety
\nsituations, and be tailored to the needs of the participants and their different roles.
\nTable 6.2: Curriculum for vaccine safety communication
\nArea (WHO-ISOP) Topics (adapted from WHO-ISOP)
\n1. Context and guidance Public health goals, immunization policies, life-cycle safety
\nmanagement of vaccines, vaccine sentiments, cognitive
\nconcepts, guidance documents relevant to vaccine safety
\ncommunication, vaccine safety communication systems,
\ncommunication plans, crisis prevention and management, legal
\nconsiderations, skills requirements
\n2.
\nCommunication with patients and
\nhealthcare professionals: tools,
\nchannels and processes
\nIndividual and mass communication, participation of the public,
\ntools and channels for listening\/understanding audiences,
\nmessaging and obtaining feedback data for evaluation
\n3.
\nCommunication with patients and
\nhealthcare professionals: contents and
\npresentation
\nTailoring for target populations, including parents, selection and
\npresentation of data, information elements and structure of the
\ntext, typical (tested) subject-matters and recommendations
\n4.
\nInteraction among stakeholders
\nincluding the media
\nCommunication for involvement of the stakeholders in
\npharmacovigilance processes and communication planning,
\ninteraction with scientific and general media, press
\nconferencing interactions between parties for evaluating
\ncommunication
\n138
\nHugman B. Expecting the worst. Uppsala: Uppsala Monitoring Centre; 2010.
\n139\tBeckmann J, Hagemann U, Bahri P, Bate A, Boyd IW, Dal Pan GJ, Edwards BD, Edwards IR, Hartigan-Go K, Lindquist M, McEwen
\nJ, Moride Y, Olsson S, Pal SN, Soulaymani-Bencheikh R, Tuccori M, Vaca CP, Wong IC. Teaching pharmacovigilance: the WHO-ISoP
\ncore elements of a comprehensive modular curriculum. Drug Saf. 2014, 37:743\u2013759.
\nChapter
\n6.
\nCapacity
\nbuilding
\nfor
\nvaccine
\nsafety
\ncommunication
\nsystems
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nTraining should enable the participants to:
\nf
\nf understand the specificities of communicating on vaccine benefit-risk profiles, vaccine licensure
\nand launch, routine immunization, mass immunization campaigns and public health emergencies;
\nf
\nf define communication objectives and desired outcomes;
\nf
\nf engage with and analyse audiences;
\nf
\nf develop strategic vaccine safety communication plans;
\nf
\nf interact efficiently with colleagues specialized in information technology;
\nf
\nf communicate in practice, including in crisis situations;
\nf
\nf confidently deal with the media.
\nTrainings should share knowledge and develop skills through plenary presentations, facilitated
\ndiscussions, case-based group work, practical tasks and simulation exercises of real life situations.
\nInnovative learning methods should be used, as they may be developed in the future. Accessing and
\nusing reliable vaccine safety information efficiently needs to be practiced too. The Vaccine Safety
\nNet of WHO is one information major source for public health authorities, health professionals and
\nthe public.140 Interpersonal communication skills need to be addressed as a key skill in all areas
\nof vaccine safety communication. During training, national communication policies and processes
\nmay be tested and improved.
\nExample 6.2.1: Training programme on vaccine safety communication by the WHO
\nRegional Office for Europe (WHO-EURO)
\nAn exclusive vaccine safety communication course has been developed by the WHO Regional
\nOffice for Europe to improve the capacity, quality and effectiveness of communication responses
\nto vaccine safety-related events with a focus on improving decision-making, response time
\nand quality in responding to these events, including situations where real or perceived adverse
\nevents are affecting trust and confidence. The training programme draws on evidence from
\nsocial psychology and communication science as well as case examples and lessons learned
\nin countries.141
\nExample 6.2.2: Training resources of the Network for Education and Support in
\nImmunisation (NESI)
\nThe Network for Education and Support in Immunisation (NESI) was officially launched on 1
\nSeptember 2002. NESI was built on the experience of the International Network for Eastern
\nand Southern Africa on Hepatitis B Vaccination, which was established in 1999 and included
\nfive universities in Eastern and Southern Africa (Kenya, Tanzania, Zambia, Zimbabwe and
\nSouth Africa), Ministries of Health in Africa and the University of Antwerp. The purpose of this
\nnetwork was to translate research on hepatitis B through capacity building and advocacy into
\nuniversal access to hepatitis B vaccination in the partner countries.
\n140
\nWHO Vaccine Safety Net. Accessible at: http:\/\/www.who.int\/vaccine_safety\/initiative\/communication\/network\/vaccine_
\nsafety_websites\/en\/.
\n141
\nThe theoretical background and the stepwise guidance are available in the WHO-EURO \u2018vaccination and trust\u2019 online library: euro.
\nwho.int\/vaccinetrust.
\nChapter
\n6.
\nCapacity
\nbuilding
\nfor
\nvaccine
\nsafety
\ncommunication
\nsystems
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nWith the development of new vaccines and increased commitment by development partners
\nand private sector initiatives to strengthen vaccine supply and immunization services, there
\nare more opportunities to prevent additional diseases in larger numbers of infants, children,
\nadolescents and adults. This led to the establishment of NESI, which is a collaborative network
\nfocusing on capacity building for the strengthening of existing immunization systems and
\nintroduction of new vaccines, with a broad technical scope and wide geographical focus.142
\n6.3. Comprehensive approach to capacity building
\nIn general, capacity building has been defined as the creation of an enabling environment with
\nappropriate policy and legal frameworks, institutional development, including community participation
\n(of women in particular), human resources development and strengthening of managerial systems.143
\nThe fundamental goal of capacity building is to enhance the ability to evaluate and address the
\ncrucial questions related to policy choices and modes of implementation among development
\noptions, based on an understanding of environment potentials and limits and of needs perceived by
\nthe people of the country concerned. It encompasses the country\u2019s human, scientific, technological,
\norganizational, institutional and resource capabilities.144
\nAny capacity building programme will therefore be specific to regions and countries, but should
\nalso provide for global learning between regions. For vaccine safety communication, it should be
\nintegrated with other capacity building conducted by countries for immunization strengthening as
\nwell as for pharmacovigilance, and public health and regulatory system strengthening.
\n142\tNetwork for Education and Support in Immunisation (NESI). Accessible at: http:\/\/www.nesi.be\/about-us\/about-us.
\n143\tUnited Nations Development Programme (UNDP). UNDP Briefing Paper. New York: UNDP, 1991.
\n144
\nUnited Nations Conference on Environment and Development (UNCED). Capacity building. In: UNCED. Agenda 21, Rio de Janeiro:
\nUNCED, 1992: Chapter 37.
\nChapter
\n6.
\nCapacity
\nbuilding
\nfor
\nvaccine
\nsafety
\ncommunication
\nsystems
\n55
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nANNEX 1:
\nREADING LIST
\nBelow is a list of official guidance documents, major reports and scientific journal publications for reading
\nand gaining further knowledge on specific aspects relevant to vaccine safety communication systems.
\nThis short list is provided in addition to the broader literature referenced in the footnotes of this report.
\nVaccine risk communication
\nUS Institute of Medicine, Vaccine Safety Forum. Risk communication and vaccination: summary of a
\nworkshop. Washington, DC: National Academy Press, 1997. Accessible at: https:\/\/www.nap.edu\/
\ncatalog\/5861\/risk-communication-and-vaccination-workshop-summary.
\nWorld Health Organization Regional Office for Europe (WHO-EURO). Vaccination and Trust. How concerns
\narise and the role of communication in mitigating crises. Copenhagen: WHO-EURO; 2017. Accessible
\nat: http:\/\/www.euro.who.int\/en\/health-topics\/disease-prevention\/vaccines-and-immunization\/
\npublications\/2017\/vaccination-and-trust-2017.
\nWorld Health Organization Regional Office for Europe (WHO-EURO). Vaccination and trust library.
\nCopenhagen: WHO-EURO, 2017. Accessible at: http:\/\/www.euro.who.int\/en\/health-topics\/disease-
\nprevention\/vaccines-and-immunization\/publications\/vaccination-and-trust.
\nWHO Collaborating Centre (WHO-CC) for Advocacy & Training in Pharmacovigilance. Vaccine
\npharmacovigilance toolkit. Accra: WHO-CC for Advocacy & Training in Pharmacovigilance, 2013.
\nAccessible at: http:\/\/vaccinepvtoolkit.org.
\nEuropean Medicines Agency (EMA) and Heads of Medicines Agencies. Guideline on good pharmacovigilance
\npractices \u2013 product- or population-specific considerations I: vaccines for prophylaxis against infectious
\ndiseases. London: EMA, 2013. Accessible at: http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/
\nregulation\/document_listing\/document_listing_000345.jsp&mid=WC0b01ac058058f32c.
\nAccelerated Development of Vaccine beNefit-risk Collaboration in Europe (ADVANCE). Developing
\nCommunication Strategies on Vaccine Benefits and Risks. ADVANCE, 2017. Accessible at: http:\/\/
\nwww.advance-vaccines.eu\/?page=publications&id=DELIVERABLES.
\nLarson H. The globalization of risk and risk perception: why we need a new model of risk communication
\nfor vaccines. Drug Saf. 2012, 35: 1053-1059.
\nVaccine hesitancy
\nWorld Health Organization Regional Office for Europe (WHO-EURO). Guide to Tailoring Immunization
\nProgrammes. Copenhagen: WHO-EURO; 2013. Accessible at: http:\/\/www.euro.who.int\/en\/health-
\ntopics\/disease-prevention\/vaccines-and-immunization\/activities\/tailoring-immunization-programmes-
\nto-reach-underserved-groups-the-tip-approach.
\nAnnex
\n1:
\nReading
\nlist
\n56
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nJarret C, Wilson R, O\u2019Leary M, Eckersberger E, Larson HJ; SAGE Working Group on Vaccine Hesitancy.
\nStrategies for addressing vaccine hesitancy: a systematic review. Vaccine 2015; 33: 4180-4190.
\nSchuster M, Duclos P, eds. WHO Recommendations Regarding Vaccine Hesitancy. Vaccine [special
\nedition]. 2015, 33 (34): 4155-4218. Accessible at: http:\/\/www.sciencedirect.com\/science\/
\njournal\/0264410X\/33\/34.
\nPeretti-Watel P, Larson HJ, Ward JK, Schulz WS, and Verger P. Vaccine hesitancy: clarifying a
\ntheoretical framework for an ambiguous notion. PLOS Currents Outbreaks, 2015 Feb 25. Edition 1.
\nLarson HJ, Jarret C, Eckersberger E, Smith DM, Paterson P. Understanding vaccine hesitancy around
\nvaccines and vaccination from a global perspective: a systematic review of published literature, 2007-2012.
\nVaccination trust-building
\nWorld Health Organization Regional Office for Europe (WHO-EURO). Vaccination and trust: How
\nconcerns arise and the role of communication in mitigating crises. Copenhagen, Denmark: WHO-
\nEURO, 2017. Accessible at: http:\/\/www.euro.who.int\/__data\/assets\/pdf_file\/0004\/329647\/
\nVaccines-and-trust.PDF?ua=1
\nWorld Health Organization Regional Office for Europe (WHO-EURO). Vaccination and trust library.
\nCopenhagen, Denmark: WHO-EURO, 2017. Accessible at: http:\/\/www.euro.who.int\/en\/health-topics\/
\ndisease-prevention\/vaccines-and-immunization\/publications\/vaccination-and-trust.
\nUnited Nations Children\u2019s Fund (UNICEF) Regional Office for South Asia. Building trust and responding
\nto adverse events following immunisation in South Asia. Kathmandu: UNICEF South Asia, 2005.
\nAccessible at: http:\/\/www.unicef.org\/rosa\/Immunisation_report_17May_05(final_editing_text).pdf.
\nEuropean Centre for Disease Prevention and Control (ECDC). Communication on immunisation:
\nbuilding trust. Stockholm: ECDC, 2012. Accessible at: http:\/\/ecdc.europa.eu\/en\/publications\/
\nPublications\/TER-Immunisation-and-trust.pdf.
\nUnited Nations Children\u2019s Fund (UNICEF). Building trust in immunization: partnering with religious leaders and
\ngroups. New York: UNICEF; 2004. Available at: https:\/\/www.unicef.org\/publications\/index_20944.html.
\nRisk perception and communication
\nBennett P, Calman K, Curtis S, Smith D. Risk Communication and Public Health. 2nd ed. Oxford:
\nOxfird University presss; 2010.
\nKasperson RE, Renn O, Slovic P, Brown HS, Emel J, Goble R, et al. The social amplification of risk:
\na conceptual framework. Risk Analysis. 1988, 8: 177-187.
\nMorgan MG, Fischhoff B, Bostrom A, Atman CJ. Risk communication: a mental models approach.
\nCambridge: Cambridge University Press, 2002.
\nSlovic P. The feeling of risk: new perspectives on risk perception. London, Washington DC: Earthscan, 2010.
\nAnnex
\n1:
\nReading
\nlist
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nHealth communication and health literacy
\nRimal RN, Lapinski MK. Why health communication is important in public health. Bulletin of WHO.
\n2009, 87: 247-247. Accessible at: http:\/\/www.who.int\/bulletin\/volumes\/87\/4\/08-056713\/en\/.
\nUS Centres for Disease Control and Prevention (CDC). Health communication and social marketing.
\nAtlanta: CDC, 2014. Accessible at: https:\/\/www.thecommunityguide.org\/sites\/default\/files\/assets\/
\nWhat-Works-Health-Communication-factsheet-and-insert.pdf.
\nUS Centres for Disease Control and Prevention (CDC). Health literacy [webpage]. Atlanta: CDC,
\n2016. Accessible at: https:\/\/www.cdc.gov\/healthliteracy\/basics.html.
\nWaisbord S, Larson H. Why invest in communication for immunization: evidence and lessons learned.
\nBaltimore, New York: Health Communication Partnership based at Johns Hopkins Bloomberg School
\nof Public Health, Center for Communication Programs and the United Nations Children\u2019s Fund
\n(UNICEF), 2005. Accessible at: http:\/\/www.who.int\/immunization\/hpv\/communicate\/why_invest_
\nin_communication_for_immunization_unicef_healthcommunicationspartnership_path_usaid.pdf.
\nStrategic health communication
\nThe Health Communication Capacity Collaborative. The P-process: five steps to strategic communication.
\nBaltimore: Johns Hopkins Bloomberg School of Public Health Center for Communication Programs, 2003.
\nAccessible at: http:\/\/www.who.int\/immunization\/hpv\/communicate\/the_new_p_process_jhuccp_2003.pdf.
\nO\u2019Sullivan GA, Yonkler JA, Morgan W, Merritt AP. A field guide to designing a health communication
\nstrategy. Baltimore, MD: Johns Hopkins Bloomberg School of Public Health, Center for Communication
\nPrograms: March 2003. Accessible at: http:\/\/ccp.jhu.edu\/documents\/A%20Field%20Guide%20
\nto%20Designing%20Health%20Comm%20Strategy.pdf.
\nMinister of Health Canada. Strategic risk communications framework for Health Canada and the
\nPublic Health Agency of Canada. Ottawa: Minister of Health Canada, 2007. Accessible at: https:\/\/
\nwww.canada.ca\/en\/health-canada\/corporate\/about-health-canada\/activities-responsibilities\/risk-
\ncommunications.html.
\nFischhoff B, Brewer NT, Downs JS. Communicating risks and benefits: an evidence-based user\u2019s
\nguide. Silver Spring: US Food and Drug Administration, 2009. Accessible at: http:\/\/www.fda.gov\/
\ndownloads\/AboutFDA\/ReportsManualsForms\/Reports\/UCM268069.pdf.
\nBahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-
\ndriven strategies. Drug Saf. 2010, 33: 1065-1079.
\nDevelopment of communication materials
\nUS Centres for Disease Control and Prevention (CDC). CDC clear communication index. Atlanta:
\nCDC, 2014. Accessible at: http:\/\/www.cdc.gov\/ccindex\/.
\nNelson DE. Communicating public health information effectively: a guide for practitioners. Washington,
\nDC: American Public Health Association, 2002.
\nHugman B. Healthcare communication. London: Pharmaceutical Press, 2013.
\nAnnex
\n1:
\nReading
\nlist
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nHealth information technology
\nU.S. Department of Health and Human Services (HHS). Health communication and health information
\ntechnology [webpage]. Washington, DC: HHS, 2017. Accessible at: https:\/\/www.healthypeople.
\ngov\/2020\/topics-objectives\/topic\/health-communication-and-health-information-technology.
\nInteracting with the news media and social media
\nWorld Health Organization Regional Office for Europe (WHO-EURO). Vaccine safety events: managing
\nthe communications response. Copenhagen: WHO-EURO, 2013. Accessible at: http:\/\/www.euro.
\nwho.int\/en\/health-topics\/communicable-diseases\/influenza\/publications\/2013\/vaccine-safety-events-
\nmanaging-the-communications-response.
\nUS Centres for Disease Control and Prevention (CDC). Health communicator\u2019s social media toolkit.
\nAtlanta: CDC, 2011. Accessible at: http:\/\/www.cdc.gov\/healthcommunication\/toolstemplates\/
\nsocialmediatoolkit_bm.pdf.
\nUS Centres for Disease Control and Prevention (CDC). CDC\u2019s guide to writing for social media.
\nAtlanta: CDC, 2012. Accessible at: http:\/\/www.cdc.gov\/socialmedia\/tools\/guidelines\/pdf\/
\nGuidetoWritingforSocialMedia.pdf.
\nInteractions between regulatory authorities and
\npatient\/consumer and healthcare professional
\norganizations
\nEuropean Medicines Agency (EMA). Revised framework for interaction between the European Medicines
\nAgency and patients and consumers and their organisations. London: EMA, 2014. Accessible at:
\nhttp:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Other\/2009\/12\/WC500018013.pdf.
\nEuropean Medicines Agency (EMA). Revised framework for interaction between the European Medicines
\nAgency and healthcare professionals and their organisations. London: EMA, 2016. Accessible at:
\nhttp:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Other\/2016\/12\/WC500218303.pdf.
\nCrisis management and communication
\nHugman B. Expecting the worst. Uppsala: Uppsala Monitoring Centre, 2010. Extract accessible
\nat: http:\/\/vaccinepvtoolkit.org\/pv-toolkit\/communication-and-crisis-management-in-vaccine-
\npharmacovigilance\/#tab-id-1.
\nWorld Health Organization Regional Office for Europe (WHO-EURO). Vaccine safety events: managing
\nthe communications response. Copenhagen: WHO-EURO, 2013. Accessible at: http:\/\/www.euro.
\nwho.int\/en\/health-topics\/communicable-diseases\/influenza\/publications\/2013\/vaccine-safety-events-
\nmanaging-the-communications-response.
\nAnnex
\n1:
\nReading
\nlist
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nCapacity-building
\nPublic Health Agency of Canada. Core competencies for public health in Canada. Ottawa: Public
\nHealth Agency of Canada, 2008. Accessible at: http:\/\/www.phac-aspc.gc.ca\/php-psp\/ccph-cesp\/
\npdfs\/cc-manual-eng090407.pdf.
\nAnnex
\n1:
\nReading
\nlist
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nANNEX 2:
\nCONTRIBUTION TO THE CIOMS GUIDE TO
\nACTIVE VACCINE SAFETY SURVEILLANCE
\nCommunication for active surveillance studies
\n145
\nA major part of conducting a study is communicating with all involved parties and the general public,
\nincluding the media. Communicating is likewise crucial for those authorizing and overseeing the
\nstudy conduct. It is crucial to communicate with policy-makers, including legislators and politicians,
\nto ensure continued support from national authorities for well-designed studies. The communication
\nprocess should commence early, when designing the study and obtaining ethical and community
\napproval prior to its start. Clarity and common agreement on the study objectives is key in this respect.
\nCommunication requires setting up a network and mechanisms for multi-party interactions and in
\nparticular exchange with the concerned communities, as well as maintaining these interactions
\nthroughout the study process. Listening is an essential part of communication, a key component which
\npromotes understanding. Listening should address questions or concerns raised by the concerned
\ncommunities and stakeholders, both proactively in the protocol and during the conduct of the study.
\nCommunication materials, such as informed consent forms, should be adapted to the target audience
\nin their information content, presentation and tone. Experience has shown that objectives, risks and
\nethical standards of studies can be questioned from inside and outside the concerned communities,
\neven when a study is already ongoing. Without continuous preparedness and responsiveness of the
\ncommunication system at any point in time, this may lead to a crisis of trust and premature ending
\nof a study to the disadvantage of individual and community health. This may happen when an AEFI
\noccurs or a new risk is identified, but also due to other concerns of the public.
\nThe practical aspects of conducting studies described below mention at which stages communication
\nbecomes particularly important. A specific section gives recommendations for communicating study
\nfindings. The fundamental guiding principle for communication is honesty about expected benefits,
\nrisks and uncertainties. Persons in charge of communication should be well trained and approach
\nthese activities in an alert, empathetic and professional manner.
\nCommunication of study findings
\nThe recommendations for communication for active surveillance studies above should be applied
\nfor communicating the study findings. The objectives of this part of the communication process
\nare to provide information about the safety and benefit-risk balance, in order to support decision-
\nmaking for immunization policies and individual informed choice in relation to immunization, and to
\nsupport the safe and effective use of vaccines. Best communication practices, developed by the
\nhealth communication sciences, for lingual, numerical and visual expression of the findings should
\nbe followed. The public also needs to receive explanations on the study rationale and be enabled to
\n145
\nCouncil for International Organizations of Medical Sciences (CIOMS). CIOMS Guide to Active Vaccine Safety Surveillance (report of
\nthe CIOMS Working Group on Vaccine Safety). Geneva: CIOMS, 2017, Chapter 4, section 4.1 Communication for the conduct of
\nAVSS, p.45 and section 4.6 Communication of study findings, p.54.
\nAnnex
\n2:
\nContribution
\nto
\nthe
\nCIOMS
\nGuide
\nto
\nActive
\nVaccine
\nSafety
\nSurveillance
\n61
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nunderstand the robustness and the credibility of the data and their analysis, including the trustworthiness
\nof those having conducted and overseen the study. This requires an in-depth understanding of the
\nknowledge and sentiments prevalent in the public and pre-testing of information materials for assuring
\nthat they\u00a0meet the communication objectives. A media conference should be considered to present
\nthe results and answer questions. The wider dissemination of the study results should reach those
\nwho need to know. Contact points for questions from the public should be in place.
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\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nANNEX 3:
\nMEMBERSHIP, EXTERNAL REVIEWERS,
\nAND MEETINGS
\nThe CIOMS Working Group on Vaccine Safety (WG) was formed in 2013 following the completion
\nof CIOMS\/WHO Working Group on Vaccine Pharmacovigilance to continue addressing unmet needs
\nin the area of vaccine pharmacovigilance and specifically address Objective #8 of WHO\u2019s Global
\nVaccine Safety Initiative regarding public-private information exchange. The original composition of
\nthe group consisted of experts from regulatory, public health, academia, and industry.
\nThe WG met in a series of eight meetings from May 2013 through March 2016. Some representatives
\nchanged during the years according to organizational and professional developments.
\nThe seven members of the Editorial Team on the CIOMS Guide to Active vaccine safety surveillance
\nwere: Steven R. Bailey (Editor-in-Chief), Novilia Bachtiar, Irina Caplanusi, Frank DeStefano, Corinne
\nJouquelet-Royer, Paulo Santos, and Patrick Zuber. CIOMS staff and advisors who supported this
\nWG include: Lembit R\u00e4go, Gunilla Sj\u00f6lin-Forsberg, Ulf Bergman, Karin Holm (Technical Collaboration
\nCoordinator and CIOMS In-house Editor), Amanda Owden, and Sue le Roux.
\nThe WG developed into three main topic groups (TG) with associated deliverables and leaders as
\nfollows:
\nTopic Group Deliverable Leadership
\nTG1 on Essential Vaccine
\nInformation (Appendix I of the
\nGuide to AVSS) –
\nAppendix I of CIOMS Guide to
\nAVSS
\nUlrich Heininger (final stage)
\nDavid Martin (early stage)
\nTG2 on Active Vaccine Safety
\nSurveillance
\nCIOMS Guide to AVSS
\n(Steven Bailey, WG Editor-in-
\nChief)
\nSteven Bailey, Mimi Darko,
\nCorinne Jouquelet-Royer (final
\nstage)
\nFran\u00e7oise Sillan (early stage)
\nTG3 on Vaccine Safety
\nCommunication
\nCIOMS Guide to Vaccine Safety
\nCommunication
\n(Priya Bahri, Editor)
\nPriya Bahri (final stage)
\nKen Hartigan-Go (first stage)
\nFelix Arellano (initial stage)
\nDuring the course of its work, topic group 3 evolved in its focus. Its genesis started from the first
\nWG meeting in London when vaccine crisis management arose as an area needing greater public-
\nprivate interaction, with Felix Arellano serving as topic group leader initially. When he later changed
\naffiliations, Ken Hartigan-Go assumed leadership and broadened the scope of the topic group.
\nSubsequently, Hartigan-Go passed leadership to Priya Bahri who stepped in to lead the topic group
\nin late 2015 and forged a new direction based on member and broader stakeholder input.
\nThe table below shows a cumulative list of WG members who have been important contributors to
\nTG3 on communication over the last four years, organized alphabetically by last name, and their
\nassociated organizations. These contributors have served as members or alternates in the Working
\nGroup for differing periods of time; some have contributed for the full duration (2013 to 2017), while
\nAnnex
\n3:
\nMembership,
\nExternal
\nReviewers,
\nand
\nMeetings
\n63
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nothers have attended at least one meeting and\/or contributed to TG3\u2019s development. In some cases
\norganizations changed names over the course of this project or contributors changed affiliations;
\nthis is not always reflected in the listing. The list generally includes the affiliation of the contributor
\nduring the time he or she participated in the topic group. Unless indicated otherwise the comments
\nfrom external reviewers were considered as expert, personal opinions and not necessarily representing
\nthose of their employers or affiliations.
\nCIOMS Working Group on Vaccine Safety — Topic Group 3 on Vaccine Safety
\nCommunication \u2013 Active members and affiliations
\nWG Member Name Organization (Stakeholder group)
\n1. Abdoellah,
\nSiti Asfijah
\nIndonesia National Agency of Drug and Food Control (Regulatory
\nauthority)
\n2. Arellano, Felix Merck (Pharma industry)
\n3. Bachtiar, Novilia Bio Farma Indonesia (Pharma industry)
\n4. Bahri, Priya European Medicines Agency (Regulatory authority)
\n5. Bergman, Ulf Council for International Organizations of Medical Sciences (CIOMS,
\nSenior Adviser)
\n6. Chandler, Rebecca Uppsala Monitoring Centre (Independent foundation and WHO
\nCollaborating Centre)
\n7. Chua, Peter Glen Philippines FDA (Regulatory authority)
\n8. Darko, Mimi Delese Ghana Food and Drug Authority (Regulatory authority)
\n9. Dodoo, Alexander University of Ghana (Academia) and WHO Collaborating Centre for
\nAdvocacy and Training in Pharmacovigilance
\n10. Hartigan-Go, Ken Philippines Dept of Health (Public health authority), Asian Institute of
\nManagement
\n11. Lindquist, Marie Uppsala Monitoring Centre (Independent foundation and WHO
\nCollaborating Centre)
\n12. Santos, Paulo Bio-Manguinhos \/ Fiocruz (Government pharma)
\n13. Zuber, Patrick World Health Organization (U.N. specialized agency for health)
\nCIOMS Working Group on Vaccine Safety meetings*
\nDate Location Host
\n1. May 2013 London, UK European Medicines Agency
\n2. September 2013 Geneva, Switzerland World Health Organization
\n3. February 2014 Atlanta, Georgia, USA Centers for Disease Control
\nand Prevention
\nAnnex
\n3:
\nMembership,
\nExternal
\nReviewers,and
\nMeetings
\n64
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nDate Location Host
\n4. May 2014 Uppsala, Sweden Uppsala Monitoring Centre
\n5. September 2014 Rabat, Morocco Centre d\u2019Antipoison et
\nPharmacovigilance de
\nMaroc
\n6. May 2015 Lyon, France Sanofi Pasteur
\n7. September 2015 Collegeville,
\nnear Philadelphia,
\nPennsylvania, USA
\nPfizer
\n8. March 2016 Accra, Ghana Ghana Food and Drug
\nAuthority
\n*
\nCosts for travel to face-to-face meetings and accommodation were covered by each Working Group
\nmember\u2019s parent organization or by CIOMS as per rules, and were not covered by the meeting
\nhosts. Numerous virtual meetings by teleconference were arranged and covered both by CIOMS
\nas well as by member organizations.
\nThe editors solicited feedback from outside experts and WHO staff for the later drafts. During the
\npublic consultation via the CIOMS website from 28 August to 11 October 2017, comments were
\nreceived from experienced institutions and public health\/vaccine communication experts. Their
\ncomments were welcoming and supportive to the report, and clarifications on the recommendations
\nand updates to some of the references, as well as additions to the reading list have been implemented
\nin the final report in response to the comments. CIOMS thanks those who commented for their time
\nand support.
\nCIOMS Working Group on Vaccine Safety — Vaccine Safety Communication \u2013
\nExternal contributors, reviewers, and public consultation
\nName Organization
\n1. Bruce Hugman Uppsala Monitoring Centre, Sweden
\n2. Katrine Bach
\nHabersaat
\nWHO Regional Office for Europe, Copenhagen, Denmark
\n3. Patrick Zuber WHO Vaccine Safety
\n4. Madhav Ram
\nBalakrishnan
\nWHO Vaccine Safety
\n5. Heidi Larson London School of Hygiene & Tropical Medicine, UK (during public
\nconsultation commented in private capacity)
\n6. Jeanet Kemmeren National Institute for Public Health and the Environment (Netherlands)
\n(during public consultation commented for the organization)
\nAnnex
\n3:
\nMembership,
\nExternal
\nReviewers,and
\nMeetings
\n65
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nName Organization
\n7. Julia Tainijoki-Seyer World Medical Association (during public consultation commented
\nfor the organization)
\n8. Robert Pless Health Canada (during public consultation commented in private
\ncapacity)
\n9. Steve Anderson U.S. Food and Drug Administration, Office of Biostatistics and
\nEpidemiology, CBER (during public consultation commented for the
\norganization)
\nAnnex
\n3:
\nMembership,
\nExternal
\nReviewers,and
\nMeetings
\n66
\nCIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
\nCopyright \u00a9 2018 by the Council for International Organizations of
\nMedical Sciences (CIOMS)
\nCIOMS Guide to vaccine safety communication. Report by topic group
\n3 of the CIOMS Working Group on Vaccine Safety. Geneva, Switzerland:
\nCouncil for International Organizations of Medical Sciences (CIOMS),
\n2018.
\nAll rights reserved. CIOMS publications may be obtained directly from
\nCIOMS using its website e-shop module at https:\/\/cioms.ch\/shop\/.
\nFurther information can be obtained from CIOMS P.O. Box 2100, CH-
\n1211 Geneva 2, Switzerland, tel.: +41 22 791 6497, www.cioms.ch,
\ne-mail: info@cioms.ch.
\nCIOMS publications are also available through the World Health
\nOrganization, WHO Press, 20 Avenue Appia, CH-1211 Geneva 27,
\nSwitzerland.
\nThe CIOMS Guide to Vaccine Safety Communication provides an overview
\nof strategic communication issues faced by medicines regulators, those
\nresponsible for vaccination policies and programmes and other stakeholders
\nincluding: (1) the launch of newly-developed vaccines for the first time to
\nmarket, (2) the introduction of current or underutilized vaccines into new
\ncountries, regions, or populations, and (3) the handling of any new safety
\nissue arising during the life-cycle of a vaccine.
\nSourcing from existing guidance documents and compiling recommendations
\nrelevant from a regulatory perspective, the Guide provides a common ground in
\na way that has not been achieved otherwise at global level. The Guide stresses
\nthe fundamental importance of regulatory bodies having a system in place
\nwith skilled persons who can efficiently run vaccine safety communication in
\ncollaboration with stakeholders. It presents information and examples with
\ncolour-coding for quick access to three levels of guidance and offers a CIOMS
\ntemplate to use to create Vaccine Safety Communication Plan.
\n9 789290 360919
\nISBN: 978-92-9036091-9<\/p>\n"},"caption":{"rendered":"

CIOMS Guide to Vaccine Safety Communication Report by Topic Group 3 of the CIOMS Working Group on Vaccine Safety Council for International Organizations of Medical Sciences (CIOMS) Geneva, Switzerland 2018 Geneva 2014 CIOMS Guide to Vaccine Safety Communication Report by Topic Group 3 of the CIOMS Working Group on Vaccine Safety Council for International Organizations […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{"sizes":{"thumbnail":{"file":"WEB-CIOMS-Guide-to-Vaccines-Safety-Communication-Guide-2018-2-pdf-100x150.jpg","width":100,"height":150,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/WEB-CIOMS-Guide-to-Vaccines-Safety-Communication-Guide-2018-2-pdf-100x150.jpg"},"medium":{"file":"WEB-CIOMS-Guide-to-Vaccines-Safety-Communication-Guide-2018-2-pdf-200x300.jpg","width":200,"height":300,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/WEB-CIOMS-Guide-to-Vaccines-Safety-Communication-Guide-2018-2-pdf-200x300.jpg"},"large":{"file":"WEB-CIOMS-Guide-to-Vaccines-Safety-Communication-Guide-2018-2-pdf-683x1024.jpg","width":683,"height":1024,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/WEB-CIOMS-Guide-to-Vaccines-Safety-Communication-Guide-2018-2-pdf-683x1024.jpg"},"full":{"file":"WEB-CIOMS-Guide-to-Vaccines-Safety-Communication-Guide-2018-2-pdf.jpg","width":806,"height":1209,"mime_type":"application\/pdf","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/WEB-CIOMS-Guide-to-Vaccines-Safety-Communication-Guide-2018-2-pdf.jpg"}}},"post":870,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/WEB-CIOMS-Guide-to-Vaccines-Safety-Communication-Guide-2018-2.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/10188"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/17"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=10188"}]}}