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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 of
Medical Sciences (CIOMS)
Geneva, Switzerland 2018
Copyright © 2018 by the Council for International Organizations of Medical Sciences (CIOMS)
ISBN: 978-92-9036091-9
All rights reserved. CIOMS publications may be obtained directly from CIOMS using its website
e-shop module at https://cioms.ch/shop/. Further information can be obtained from CIOMS P.O.
Box 2100, CH-1211 Geneva 2, Switzerland, tel.: +41 22 791 6497, www.cioms.ch,
e-mail: info@cioms.ch.
CIOMS publications are also available through the World Health Organization, WHO Press,
20 Avenue Appia, CH-1211 Geneva 27, Switzerland.
Citations:
CIOMS Guide to vaccine safety communication. Report by topic group 3 of the CIOMS Working
Group on Vaccine Safety. Geneva, Switzerland: Council for International Organizations of Medical
Sciences (CIOMS), 2018.
Note on style:
This publication uses the World Health Organization’s WHO style guide, 2nd Edition, 2013 (WHO/
KMS/WHP/13.1) wherever possible for spelling, punctuation, terminology and formatting which
combines British and American English conventions.
Disclaimer:
The authors alone are responsible for the views expressed in this publication and those views
do not necessarily represent the decisions, policies or views of their respective institutions or
companies.
Design and Layout: Paprika (Annecy, France)
ACKNOWLEDGEMENTS
The Council for International Organizations of Medical Sciences (CIOMS) gratefully acknowledges
the contributions of the members of the CIOMS Working Group on Vaccine Safety (WG) who served
in the topic group 3 that produced this Guide to Vaccine Safety Communication. Generous support
from medicines regulatory authorities, industry, academia and other organizations and institutions
provided experts and resources that facilitated the work culminating in this publication.
Each WG member and consulted reviewer participated according to their abilities and time demands
as actively as they were able in the meetings and discussions, teleconference calls, email exchanges,
drafting and redrafting of texts and their review, which enabled the WG and topic groups to bring
the project to a successful conclusion. During the multiyear process, new members from some
organizations were invited, in capacity of their expertise, to cover changes in assignments.
During the course of its work, topic group 3 evolved in its focus. Its genesis occurred at the first
WG meeting in London when vaccine crisis management arose as an area needing greater public-
private interaction, with Felix Arellano serving as topic group leader initially. Within the first year,
his professional affiliation changed and he had to pass the baton. Ken Hartigan-Go accepted CIOMS’s
request to assume leadership for the topic group, broadening its scope. Following his subsequent
organizational move, he passed on the lead role to Priya Bahri, who was invited by CIOMS to take
charge of the topic group. Under Dr. Bahri’s leadership, the topic group forged a new direction
including additional member input and expanded stakeholder consultation.
Primary credit for the development, research, writing, and publication of this document goes to Priya
Bahri as Editor of the Guide to Vaccine Safety Communication. CIOMS would also like acknowledge
the European Medicines Agency for generously making Dr. Bahri’s time available. Dr. Bahri’s vision
focused the topic group and through her expertise and diligent collaboration process, she brought
the current Guide to fruition. Additionally, the advice and support from Patrick Zuber who heads
WHO Vaccine Safety and his staff was invaluable. Karin Holm acted as the CIOMS In-House Editor
throughout the process.
CIOMS appreciates the additional members of the WG who contributed at various times on the
development and output of this topic group: Siti Asfijah Abdoellah, Novilia Bachtiar, Ulf Bergman,
Rebecca Chandler, Peter Glen Chua, Mimi Delese Darko, Alexander Dodoo, Ken Hartigan-Go, Marie
Lindquist, and Paulo Santos. Outside expertise is gratefully acknowledged from Bruce Hugman,
Katrine Bach Habersaat, and Madhav Ram Balakrishnan.
During the public consultation via the CIOMS website from 28 August to 11 October 2017, comments
were received from experienced institutions, namely the National Institute for Public Health and the
Environment of the Netherlands, the Center of Biologics Evaluation and Research (CBER) at the US
Food and Drug Administration and the World Medical Association (WMA) (see Annex 3). In addition,
Heidi Larson from the London School of Hygiene and Tropical Medicine and Robert Pless from Health
Canada, commented as individual experts. Their comments were welcoming and supportive to the
report, and clarifications on the recommendations and updates to some of the references, as well
as additions to the reading list have been implemented in to the final report in response to the
comments. Unless indicated otherwise the comments from external reviewers were considered as
expert, personal opinions and not necessarily representing those of their employers or affiliations.
CIOMS thanks those who have commented for their time and support.
Geneva, Switzerland, December 2017
Lembit Rägo, MD, PhD
Secretary-General, CIOMS
iii
CIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
CONTENTS
ACKNOWLEDGEMENTS�� III
FOREWORD�� VIII
ACRONYMS AND ABBREVIATIONS��IX
READER’S GUIDE��X
CHAPTER 1. INTRODUCTION��1
CHAPTER 2. CONSIDERATIONS FOR VACCINE SAFETY COMMUNICATION��7
2.1.
Audiences and aims of vaccine safety communication………………………………………………………………. 7
Figure 2.1: The social-ecological model (SEM)…………………………………………………………………………8
2.2.
Communicating evidence and uncertainties for informed decision-making……………………………………… 9
Guidance Summary 2.2: Addressing uncertainty in vaccine safety………………………………………………10
2.3.
Transparency for honest communication and public trust-building………………………………………………. 11
Guidance Summary 2.3: Building trust in vaccine safety………………………………………………………….. 11
Example 2.3: Re-building trust in the MMR vaccine in the United Kingdom…………………………………….12
2.4.
Perceptions of risk as a trigger of vaccine hesitancy……………………………………………………………….15
Figure 2.4: The WHO Strategic Advisory Group of Experts (SAGE) on Immunization Model of
determinants of vaccine hesitancy ……………………………………………………………………………………..16
Guidance Summary 2.4: Addressing vaccine hesitancy……………………………………………………………18
Example 2.4.1: Overcoming hesitancy against the MMR vaccine in sub-populations in Sweden………….18
Example 2.4.2: The need for understanding public concerns over HPV vaccines prior to
licensure and launch………………………………………………………………………………………………………..20
CHAPTER 3. PRODUCT LIFE-CYCLE MANAGEMENT APPROACH TO VACCINE
SAFETY AND COMMUNICATION��22
3.1.
Communication as part of vaccine pharmacovigilance……………………………………………………………..22
3.2. Pre-licensure and launch phase…………………………………………………………………………………………..23
Example 3.2.1: The need for understanding concerns in different communities over the Ebola
virus and vaccines prior to launching clinical trials…………………………………………………………………..23
Guidance Summary 3.2.1: Concept of risk management systems for medicinal products………………..25
Figure 3.2: Risk management cycle…………………………………………………………………………………….25
Guidance Summary 3.2.2: Types of risk minimization measures for medicinal products…………………..26
Example 3.2.2: Risk management planning for DTPw-HBV quadrivalent vaccine……………………………..26
Example 3.2.3: The introduction of pentavalent vaccines in Kerala, India, supported by close
interactions with the healthcare community and the media ………………………………………………………. 27
3.3. Post-licensure phase………………………………………………………………………………………………………..28
Example 3.3.1: Addressing the risk of febrile seizures with a serogroup
B meningococcal vaccines in the United Kingdom…………………………………………………………………..29
Example 3.3.2: Addressing the safety concern of narcolepsy for the H1N1 pandemic influenza
vaccine used in Sweden…………………………………………………………………………………………………… 31
CHAPTER 4. VACCINE SAFETY COMMUNICATION PLANS (VACSCPS)��33
4.1.
Application of a strategic communication approach to vaccine safety………………………………………….33
Figure 4.1: The P-Process of strategic health communication……………………………………………………33
Checklist 4.1: Management considerations for VacSCPs………………………………………………………….34
4.2.
Developing VacSCPs on the basis of a model template……………………………………………………………35
Template 4.2: Template for strategic vaccine type- and situation-specific vaccine safety
communication plans (VacSCPs)…………………………………………………………………………………………36
Guidance Summary 4.2: Developing communication strategies on vaccine benefits and risks………….. 37
4.3. Monitoring, evaluating and maintaining VacSCPs…………………………………………………………………….38
4.3.1
Monitoring of debates and sentiments in communities and the public…………………………………..39
Example 4.3.1: Social media monitoring during polio supplementary immunization activities (SIA)
in Israel………………………………………………………………………………………………………………………..40
Example 4.3.2: Utility of online news media monitoring for prepared communicating of the
outcome of a safety assessment for HPV vaccines at the European Medicines Agency (EMA)……………40
CHAPTER 5. VACCINE SAFETY COMMUNICATION SYSTEMS��42
5.1.
Functions of vaccine safety communication systems……………………………………………………………….42
Checklist 5.1: Key functions of vaccine safety communication systems……………………………………….42
5.2. Multistakeholder network………………………………………………………………………………………………….42
Table 5.2.1: Main stakeholders involved in the vaccine safety communication process ……………………43
Checklist 5.2: Establishing and maintaining national stakeholder networks……………………………………43
Table 5.2.2: Purposes of multistakeholder interactions ……………………………………………………………44
Example 5.2: Managing an adverse event following immunization with HPV vaccine in the United
Kingdom ………………………………………………………………………………………………………………………45
5.3.
Regional and international awareness and collaboration……………………………………………………………50
Figure 5.3: Relationships of parties in global vaccine safety………………………………………………………50
CHAPTER 6. CAPACITY BUILDING FOR VACCINE SAFETY COMMUNICATION SYSTEMS52
6.1. Skills and capacity requirements………………………………………………………………………………………..52
Checklist 6.1: Skills and capacity requirements for vaccine safety communication………………………….52
6.2. Contents and objectives of training……………………………………………………………………………………..53
Table 6.2: Curriculum for vaccine safety communication…………………………………………………………..53
Example 6.2.1: Training programme on vaccine safety communication by the WHO Regional
Office for Europe (WHO-EURO)……………………………………………………………………………………………54
Example 6.2.2: Training resources of the Network for Education and Support in Immunisation (NESI)…54
6.3. Comprehensive approach to capacity building……………………………………………………………………….55
ANNEX 1: READING LIST��56
ANNEX 2: CONTRIBUTION TO THE CIOMS GUIDE TO ACTIVE VACCINE SAFETY
SURVEILLANCE�� 61
ANNEX 3: MEMBERSHIP, EXTERNAL REVIEWERS, AND MEETINGS��63
CIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
v
Level 1: CIOMS Summaries
Table 5.2.1: Main stakeholders involved in the vaccine safety communication process ………….43
Table 5.2.2: Purposes of multistakeholder interactions ……………………………………………………….44
Table 6.2: Curriculum for vaccine safety communication………………………………………………………53
Checklist 4.1: Management considerations for VacSCPs��34
Checklist 5.1: Key functions of vaccine safety communication systems��42
Checklist 5.2: Establishing and maintaining national stakeholder networks��43
Checklist 6.1: Skills and capacity requirements for vaccine safety communication��52
Template 4.2:
Template for strategic vaccine type- and situation-specific vaccine safety
communication plans (VacSCPs)��36
Level 2: Guidance Summaries
Guidance Summary 2.2: Addressing uncertainty in vaccine safety��10
Guidance Summary 2.3: Building trust in vaccine safety��11
Guidance Summary 2.4: Addressing vaccine hesitancy��18
Guidance Summary 3.2.1: Concept of risk management systems for medicinal products��25
Guidance Summary 3.2.2: Types of risk minimization measures for medicinal products��26
Guidance Summary 4.2: Developing communication strategies on vaccine benefits and risks
37
SUMMARIES & EXAMPLES
Legend:
f
f CIOMS summaries with key references in Tables grey, Checklists red, and a Template in yellow
(LEVEL 1)
f
f Guidance Summaries of existing practical guidance documents with precise (linked) references
blue and multicoloured Figures (LEVEL 2)
f
f Examples from real-world with references to source green (LEVEL 3)
vi
CIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
Level 3: Examples
Example 2.3: Re-building trust in the MMR vaccine in the United Kingdom��12
Example 2.4.1: Overcoming hesitancy against the MMR vaccine in sub-populations in Sweden18
Example 2.4.2:
The need for understanding public concerns over HPV vaccines prior to
licensure and launch��20
Example 3.2.1:
The need for understanding concerns in different communities over the
Ebola virus and vaccines prior to launching clinical trials��23
Example 3.2.2: Risk management planning for DTPw-HBV quadrivalent vaccine��26
Example 3.2.3:
The introduction of pentavalent vaccines in Kerala, India, supported by
close interactions with the healthcare community and the media ��27
Example 3.3.1:
Addressing the risk of febrile seizures with a serogroup
B meningococcal vaccines in the United Kingdom��29
Example 3.3.2:
Addressing the safety concern of narcolepsy for the H1N1 pandemic
influenza vaccine used in Sweden��31
Example 4.3.1:
Social media monitoring during polio supplementary immunization
activities (SIA) in Israel��40
Example 4.3.2:
Utility of online news media monitoring for prepared communicating of
the outcome of a safety assessment for HPV vaccines at the European
Medicines Agency (EMA)��40
Example 5.2:
Managing an adverse event following immunization with HPV vaccine in
the United Kingdom ��45
Example 6.2.1:
Training programme on vaccine safety communication by the WHO
Regional Office for Europe (WHO-EURO)��54
Example 6.2.2:
Training resources of the Network for Education and Support in
Immunisation (NESI)��54
Figures
Figure 2.1: The social-ecological model (SEM)……………………………………………………………………… 8
Figure 2.4:
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization Model
of determinants of vaccine hesitancy ……………………………………………………………….16
Figure 3.2: Risk management cycle……………………………………………………………………………………25
Figure 4.1: The P-Process of strategic health communication………………………………………………33
Figure 5.3: Relationships of parties in global vaccine safety…………………………………………………50
vii
CIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
FOREWORD
Since its inception in 1949 by the World Health Organization and UNESCO, the Council for International
Organizations of Medical Sciences (CIOMS) has contributed in various roles by taking up scientific
topics benefiting from collaboration across the sectors of public health agencies, medicines regulatory
or competent authorities, the pharmaceutical industry, and academia. Over the years CIOMS has
evolved into an independent, non-governmental international organization that provides a neutral
and objective forum conducive to public-private interaction on issues concerning medical sciences,
most recently focused around pharmacovigilance and bioethics.
In 2013 a new working group was formed, the CIOMS Working Group on Vaccine Safety (WG) to
address unmet needs in the area of vaccine pharmacovigilance and specifically address Objective
#8 of WHO’s Global Vaccine Safety Initiative regarding public-private information exchange. The WG’s
report issued at the beginning of 2017, CIOMS Guide to Active Vaccine Safety Surveillance (Guide
AVSS)1, offers a practical step-by-step approach and a graphic algorithm to aid immunization
professionals and decision-makers in determining the best course of action when confronting such
challenges. The Guide AVSS provides a structured process, a checklist for evaluating the extent of
data resources, and several case studies for review.
This current CIOMS Guide to Vaccine Safety Communication (Guide or report) stemmed from
topic group 3 of the WG which brought together, in a unique forum, pharmacovigilance specialists
and other experts from regulatory and public health authorities, the World Health Organization,
and academia as well as manufacturers in emerging and industrialized countries. The Guide presents
recommendations for vaccine safety communication with a specific focus on regulatory bodies.
A number of communication guidance documents already exist for immunization programmes
covering how to manage communication when an adverse event occurs. Few have thus far been
issued addressing the specific needs of regulatory bodies or competent authorities — whether
they be established authorities in high-income countries or developing authorities in resource-limited
countries. Little has been published for these groups in relation to communication about risks,
uncertainties, safety and safe use of the vaccine products they license.
This CIOMS report aims to fill this gap. Although the Guide sources from existing guidance documents,
it compiles recommendations relevant from a regulatory perspective and creates a common ground
in a way that has not been achieved otherwise at global level. The Guide stresses the fundamental
importance of regulatory bodies having a system in place with skilled persons who can efficiently
run vaccine safety communication in collaboration with stakeholders.
1 Council for International Organizations of Medical Sciences (CIOMS). CIOMS Guide to Active Vaccine Safety Surveillance (report of
the CIOMS Working Group on Vaccine Safety). Geneva: CIOMS, 2017.
viii
CIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
ACRONYMS AND ABBREVIATIONS
AEFI
AVSS
CIOMS
ECDC
EMA
GACVS
GVSI
H1N1
HCP
HPV
KAP
MMR
NGO
NIP
NRA
PV
RLC
SAGE
SEM
SIA
TIP
UMC
UNICEF
USFDA
VacSCP
VSC
VSN
WHO
Adverse event following immunization
Active vaccine safety surveillance
Council for International Organizations of Medical Sciences
European Centre for Disease Prevention and Control
European Medicines Agency
Global Advisory Committee on Vaccine Safety
Global Vaccine Safety Initiative
A pandemic flu strain
Healthcare professionals
Human papillomavirus
Knowledge, attitudes, practices
Measles mumps rubella
Non-governmental organization
National immunization program
National regulatory authority
Pharmacovigilance
Resource-limited country
Strategic Advisory Group of Experts
Social-Ecological Model
Supplementary immunization activity
Tailoring Immunization Programmes
Uppsala Monitoring Centre
United Nations Children’s Fund
United States Food and Drug Administration
Vaccine safety communication plan
Vaccine safety communication
Vaccine Safety Net
World Health Organization
ix
CIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
READER’S GUIDE
The CIOMS Guide to Vaccine Safety Communication (Guide or report) provides an overview of
strategic communication issues faced by regulators, those responsible for vaccination policies and
programmes and other stakeholders involved in introducing: (1) newly-developed vaccines for the first
time to market or (2) current or underutilized vaccines into new countries, regions, or populations.
The Guide discusses the complexity of vaccine safety communication (see Chapter 2) and builds upon
already existing expert recommendations to fill a specific niche that is meant to be particularly useful
to regulatory authorities in resource-limited countries (RLCs). The Guide draws upon recommendations
from numerous institutional materials for compilation of guidance, for example, on aims (see §2.1),
key functions (see §5.1), networks (see §5.2 and §5.3) and capacity-building (see Chapter 6). Where
existing recommendations have been summarized, this has been done in a very condensed manner.
The references provided allow for returning to the source documents for more in-depth reading on
the concepts and their background if required.
Recognizing the successful implementation of strategic communication for some objectives in other
areas of health, the recommendations in the Guide are based on this strategic process. However
this report is not a process guide, as such processes can be adapted for the specific needs of
individual regulatory bodies from general sources on health communication.
More practically and immediately tangible, the Guide presents the CIOMS template of a vaccine safety
communication plan (VacSCP) to provide for proactive, prepared and responsive communication.
The template allows for specific planning, monitoring and adapting of communications for each
vaccine type in the given local situation (see CIOMS VacSCP Template §4.2). This is important as
public sentiments differ locally by vaccine type, disease epidemiology and public debate.
As this report supports regulatory bodies, it discusses how assessment for licensure, pharmacovigilance
and communication should be interactive processes within these bodies (see Chapter 3). It also
considers the context regulators have to keep awareness of – in particular tensions between evidence
and uncertainty, public trust and mistrust, and vaccine acceptance and vaccine hesitancy (see
§2.2 and §2.4), all subject to sudden or slow change over time. It may be most appropriate for a
regulatory body to build up their vaccine safety communication system and VacSCPs gradually over
time in accordance with local needs.
The recommendations in this report are not only based on existing guidance, but also on established
practices, experiences of immunization programmes and regulatory bodies as well as evidence
from relevant research. All references are provided in footnotes. Where recommendations and
considerations are not referenced, these constitute the views of the CIOMS topic group.
The Guide can be read in many ways. Of course, it can be read from beginning to end to follow its
primary logic – that is, from aims and context, over pharmacovigilance and communication planning,
to building up the necessary communication system. Readers may however use any section as
entry point, depending on one’s background and most immediate interest. Cross-references to the
other sections (with hyperlinks in the digital version) are provided throughout the report allowing for
flexible reading. Nonetheless Chapter 1’s introduction and overview will be a suitable section with
which to start upfront for all readers to understand the underlying approach of the Guide. The report
also presents a number of examples of successful communication interventions around the globe
to illustrate the recommendations (highlighted in green). These examples can also be read first to
enter the report through gaining an initial practical understanding of the recommendations.
An additional reading list can be found in Annex I, organized by topics, guides readers for further
learning and training.
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CIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
CHAPTER 1.
INTRODUCTION
Vaccines transformed global health and continue to yield health gains in this century. Through
improving health, immunization promises further benefits for individuals and societies at large,
increasing earning power and saving healthcare costs. The range of vaccines and diseases they
can prevent is expanding. Consequently, the need for strong safety surveillance of vaccine products
and clear communication to inform the public is growing as well.
The World Health Organization launched the Global Vaccine Action Plan (GVAP) in 2012 for the period
through 2020.2 The GVAP is a roadmap setting targets for each vaccine-preventable disease and
addressing how to bestow the full benefits of immunization to all people. Important GVAP goals are
to add polio to the list of globally eradiated diseases (to join smallpox) and to accelerate progress
towards the elimination of measles, rubella and neonatal tetanus. Priorities include the additional
control of diseases that can be addressed through improving coverage rates of existing routine
immunizations (e.g. diphtheria, Haemophilus influenzae type B (Hib), hepatitis B virus, pertussis,
rubella, tetanus, and tuberculosis), and the development and use of new vaccines. The Strategic
Advisory Group of Experts (SAGE) on Immunization to WHO recently produced an Assessment
Report of GVAP and advised that post-2020, “the challenge will be to ensure that these gains are
protected and further extended – to ensure more vaccines reach more people more rapidly.”3 This
could involve countries and stakeholders directing more resources towards:4
1. recently developed and/or underutilized vaccines (e.g. humanpapilloma virus (HPV), pneumococcal,
and rotavirus);
2. vaccines intended for regionally prevalent diseases (e.g. cholera, Japanese encephalitis,
meningitis A, seasonal influenza, and yellow fever); as well as
3. new vaccines in development or on the horizon (e.g. against dengue, Ebola, or Zika viruses,
human immunodeficiency virus (HIV), malaria, sexually-transmitted diseases, or an improved
vaccine against tuberculosis).
The Council for International Organizations of Medical Sciences (CIOMS) can make an important
contribution to meeting this challenge as one of its major aims is: “contributing to harmonised views
of international systems and terminologies used for the safety surveillance of medicinal products and
vaccines between stakeholders.” The independent status of CIOMS has permitted the organization
over the decades of its existence to facilitate the collaborations and expertise of senior scientists from
national medicines regulatory authorities, academia, public health agencies, representative bodies of
medical specialties and research-based biopharmaceutical companies. CIOMS has convened numerous
working groups on pharmacovigilance topics, including one that produced the CIOMS report on Definition
and Application of Terms for Vaccine Pharmacovigilance and an annex on Vaccines in the CIOMS IX
report on Practical Approaches to Risk Minimisation for Medicinal Products.5
2 WHO Global vaccine action plan 2011-2020
http://www.who.int/immunization/global_vaccine_action_plan/GVAP_Guiding_Principles_Measures_of_Success_and_Goals.pdf?ua=1.
3 2017 Assessment Report of the Global Vaccine Action Plan Strategic Advisory Group of Experts on Immunization. Geneva: World
Health Organization; 2017. Licence: CC BYNC-SA 3.0 IGO, p.28
4 SAGE meeting reports available at www.who.int/immunization/sage/meetings/2017/october/en/, accessed October 2017.
5 CIOMS website, https://cioms.ch/about/
Chapter
1.
Introduction
1
CIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
The Working Group’s mandate, aim and addresses
To continue this work, the CIOMS Working Group on Vaccine Safety (WG) was formed to support the
World Health Organization (WHO) in the implementation of the strategic objective 8 of its Blueprint
of the Global Vaccine Safety Initiative (GVSI)6, which is: “to put in place systems for appropriate
interaction between national governments, multilateral agencies7 and manufacturers at national,
regional and international levels” particularly concerning underutilized and new vaccines expected
to be of global, regional or local significance in the near- to long-term.
The WG divided itself into three key areas affecting vaccine safety when a newly-developed vaccine
or new-to-the-country vaccine is introduced into a population. Topic group1 focused on examining
the safety baseline data needed by country regulatory authorities and immunization programmes
and contributed the Appendix I: Essential Vaccine Information (EVI) to the CIOMS Guide to Active
Vaccine Safety Surveillance (Guide AVSS). Topic group 2 took charge of contributing the main body
of the Guide AVSS. Topic group 3 concentrated on the communications aspect of vaccine safety.
Through the course of multistakeholder discussion and collaboration, over several meetings topic group
3 determined its critical value would be to create this CIOMS Guide to Vaccine Safety Communication
(referred to as Guide or report) which complements other helpful documents from WHO and other
organizations by filling a gap for regulatory needs applicable globally. The Guide additionally supports
the implementation of strategic objective 3 of the GVSI Blueprint, which is “to develop vaccine
safety communication plans at country level, to promote awareness of vaccine risks and benefits,
understand the perception of the risk and prepare for managing any adverse events and concerns
about vaccine safety promptly.” Therefore this report is addressed particularly to the authorities in
charge of vaccine pharmacovigilance at country level – usually the national regulatory authorities.
While this report addresses regulatory bodies and supports WHO’s GVSI, the recommendations
are also applicable to vaccine safety communication in general. In particular, national immunization
programmes or other groups which may exist in some countries, have a major responsibility for
programme implementation and delivery, assuming an important role relative to vaccine safety and
communication. While they may have specific guidance documents available, the approach taken in this
report might prove informative for them. In addition, vaccine manufacturers might learn from this report
a new perspective about safety communication systems to improve their corporate pharmacovigilance
systems and product-related communication interventions, facilitating interactions with their medical
information and public relation functions internally, and with governmental bodies externally.
Background of existing guidance documents and
approach taken by the Working Group
A number of vaccine communication guides already exist (and were reviewed by the topic group),
but these are often field-oriented and primarily provide for those in charge of immunization
programmes, covering in particular how to be prepared and manage communication when an
adverse event occurs. Some also include guidance for healthcare professionals. So far, only a few
regulatory bodies have issued guidance addressing the specific needs of regulators in relation to
6 World Health Organization (WHO). Global Vaccine Safety Blueprint (WHO/IVB 12.07). Geneva: WHO, 2012. Accessible at: http://
extranet.who.int/iris/restricted/bitstream/10665/70919/1/WHO_IVB_12.07_eng.pdf?ua=1.
7 Agencies formed by several countries to serve them, such as UN system and other regional and sub-regional organizations.
Chapter
1.
Introduction
2
CIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
communicating about risks, uncertainties, safety and safe use of the vaccine products they license
(e.g. European Medicines Agency8).
Effective communication of assessment outcomes is, however, an important part of the mandate of
regulatory bodies and expected by the public and all stakeholders, at the time a vaccine product is
newly launched in a country as well as if a concern emerges later in the product life-cycle. Although this
report sources from existing guidance documents, in particular those for immunization programmes,
it compiles recommendations relevant from a regulatory perspective and creates a common ground
in a way that has not been achieved otherwise at global level.
The existing guidance documents have been selected as references for their respective focus on
certain elements of communication and the expertise they contain, reflecting current evidence and
authority. They have mainly been issued by major organizations, like WHO and national and regional
public health agencies, such as the Centers for Disease Control and Prevention (CDC) in the United
States and the European Centre for Disease Prevention and Control (ECDC) in the European Union.
These organizational references have been complemented by publications in scientific journals on
specific aspects of communication. The recommendations in this report are also based on established
practices, experiences of immunization programmes and regulatory bodies, as well as evidence
from relevant research and duly cited in footnotes.
Where recommendations and considerations are not referenced, these constitute the views of the
CIOMS topic group.
Overall, topic group 3 dedicated itself to issue a ‘guide’, which means to provide recommendations based
on established principles, research evidence and example-based learning. As with recommendations for
any complex intervention in highly variable and continuously changing situations, the recommendations
cannot be specific. Therefore this Guide is intended to provide primarily to regulators, but also to
other relevant parties in charge of vaccination programmes on the country level, a foundation for
understanding complex communication issues related to vaccines safety. In addition, it aims to
provide general recommendations on how to create vaccine safety communication plans and deliver
in real life situations high quality communication input messages for those actually in charge of the
communications.
The strategic approach to communication
As some major health objectives – for example, the prevention of infection with human immunodeficiency
virus (HIV) – have been achieved with support of strategic communication, the recommendations in
the current Guide are based on this strategic process. However this report is not a process guide
detailing who has to do what, when, why and how, as such processes can (and should) be adapted
for the specifics of individual regulatory bodies from general sources on health communication.
8 European Medicines Agency (EMA) and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices – product-
or population-specific considerations I: vaccines for prophylaxis against infectious diseases. London: EMA, 12 December 2013.
Accessible at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.
jsp&mid=WC0b01ac058058f32c.
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The concept of communication plans
More practically and immediately tangible, this report presents the CIOMS template of a vaccine
safety communication plan (VacSCP) that allows for specific planning, monitoring and adapting of
communication that is proactive, prepared and responsive.
Topic group 3 of the CIOMS Working Group on Vaccine Safety proposes to define vaccine safety
communication plans at country level as “individual vaccine safety communication plans that are
specific to vaccine types and the local situation” (VacSCPs, see Chapter 4).
These VacSCPs need to be kept up-to-date in accordance with changing evidence and information on the
quality and safety of vaccine products and their effectiveness. VacSCPs should be periodically adapted to
the context of evolving public health needs and the evolving debates at policy level and in the public domain.
As regulators monitor the benefit-risk balance of the vaccines they license, they should ideally also monitor
the public debate and possible rumours about vaccines in the communities and the media. For regulatory
communication to be most effective, their communication plans and messages can address concerns
raised by the public and fill information needs. It is understood that the individual VacSCPs may have
generic elements in common or even be part of a single planning framework at country level, or that
there will be local prioritization concerning which vaccines need a communication plan.
In any case, the VacSCPs are meant to focus on the safety of vaccine products as assessed by
the applicable regulatory authority and do not opine on immunization policy, which falls under
the responsibility of the public health authorities. The information provided by regulatory bodies
needs, however, to be useful to others for making decisions on immunization programmes and
immunizations of individuals. This requires listening to stakeholders as part of the communication
process, in order to understand which concerns and information needs have to be addressed by
regulators responsible for vaccine safety.
Overall, vaccine safety communication consists of complex processes of listening and messaging
between the regulatory bodies and all stakeholders, including the manufacturers responsible for
vaccine safety, the multiple institutional parties involved in immunization, the media, and most
importantly, the communities and the people who should benefit from vaccines.
The concept of a systems approach to vaccine
safety communication
As health and information needs are evolving, VacSCPs cannot be static plans. Therefore the topic
group has taken the view that in order to manage vaccine safety communication professionally and to
a high quality standard, a system is needed at the level of regulatory bodies for developing, updating,
implementing and evaluating these plans. Such vaccine safety communication systems should
operate continuously and always be designed for proactivity, preparedness and responsiveness. It is
recommended to put a system in place with dedicated people and resources with defined objectives,
functions and expertise (see §5.1). Capacity-building in this respect is very important (see Chapter 6).
This report provides added value by presenting a “systems approach” with an integration of
communication as part of pharmacovigilance and risk management for vaccine products (see Chapter
3). In this respect, it is stressed that communication, no matter how skilful and carefully designed,
cannot and is not meant to disguise any lack of evidence, uncertainty or flaws in the processes of
safety surveillance, risk management or regulatory decision-making. The link between communication
and transparency is vital (see §2.3).
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In order to understand each given situation and to design effective communication interventions, it is
necessary to build relationships with representatives of all stakeholders. This requires, as part of the
communication system, establishment and maintenance of local and global stakeholder networks,
underpinned by policies that prevent undue influences (see §5.2 and §5.3).
Contextual considerations
Of course, those engaged in vaccine safety communication cannot ignore the contexts in which they
work. While vaccines have been one of the most successful health interventions and vast population
groups agree with immunization,9 at the same time there is a debate in the public domain around
vaccine benefits, risks and uncertainties, and some groups and individuals are hesitant or reject
vaccines, or develop mistrust in scientists and officials (see §2.4) and collaborating with stakeholders
is therefore vital (see §2.3).
The systems and planning approach referenced in this Guide is considered the best way to manage
communication in the event of a public health emergency, such as a pandemic, and to prevent or
manage situations of crisis, which can be triggered, for example, by a public reaction to a safety
concern.
Global scope of the report
Established authorities in both high-income countries and resource-limited countries (RLCs) share
interests and concerns around good communication on vaccine safety, and seek approaches for
improvement. The recommendations of this report are therefore valid for any country, but specific
consideration has been given to resource limitations in many countries. The components for a
vaccine safety communication system are presented with a view to building them up gradually,
taking into account local resources, opportunities and priorities. In this way, a tailored system can
be built over time.
Global sharing of examples and experience
Examples illustrating aspects of successful communication interventions and underpinning the
recommendations are taken from different countries around the globe to demonstrate feasibility
and value. Some examples specifically show how they can be implemented in RLCs.
The topic group deliberately did not include examples of unsuccessful communication, because
rarely one has all the information to judge a specific situation, and it was also not within the scope
of the topic group to engage with those responsible for communication in such cases for in-depth
reviews and lessons learnt. Preference was therefore given to positive examples of successful
communication to stay within a constructive spirit.
9 “Immunization” as used in this report means the usage of a vaccine for the purpose of immunizing individuals. It is generally
acknowledged that (1) “immunization” is a broader term than “vaccination”, including active and passive immunization, and (2)
immunization when used strictly implies an immune response. In keeping with other key published literature in the field of immunization,
the terms “immunization” and “vaccination” are generally used interchangeably in the current report. (see Council for International
Organizations of Medical Sciences (CIOMS). Definition and application of terms of vaccine pharmacovigilance (report of CIOMS/WHO
Working Group on Vaccine Pharmacovigilance). Geneva: CIOMS,2012). Accessible at: https://cioms.ch/shop/product/definitions-
and-applications-of-terms-for-vaccine-pharmacovigilance/.
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Relationship of this report with other CIOMS reports
on vaccines
This report is related to the other report of the CIOMS Working Group on Vaccine Safety, namely the CIOMS
Guide to Active Vaccine Safety Surveillance (Guide AVSS).10 Topic group 3 made a contribution to that
Guide AVSS (see Annex 2 for description), given that active safety surveillance and communication are
processes running in parallel and should be integrated via pharmacovigilance systems (see Chapter 3).
This report is also related to the CIOMS Definition and Application of Terms for Vaccine Pharmacovigilance,
from where it draws the concept of vaccine pharmacovigilance and agreed terminology.11
It does not include the reporting or identifying of individual adverse events following immunization
(AEFIs)12, which can be considered as a type of communication, but for which specific guidance exists.13
Applicability of this report to medicines beyond vaccines
While developing the report, reviewed documents included those not specific to vaccines, but more
broadly to communication about medicinal products by regulatory bodies.14, 15, 16, 17
Therefore, CIOMS would like to make regulatory bodies aware that the recommendations in this
report could be leveraged for use in their communication systems and processes for medicines
other than vaccines. The same principles, systems approach, communication plan template and
related processes proposed for vaccines could be applied and tailored to other medicinal product
classes, as each class will have its specific challenges in communicating for understanding, informed
choice, safe and trusted use as well as adherence. There are currently few guidance documents
available for other medicinal product classes of similar content combining concepts and examples,
although general guides exist.18
10 Council for International Organizations of Medical Sciences (CIOMS). CIOMS Guide to Active Vaccine Safety Surveillance (report of
the CIOMS Working Group on Vaccine Safety). Geneva: CIOMS, 2017.
11 Council for International Organizations of Medical Sciences (CIOMS). Definition and application of terms of vaccine pharmacovigilance
(report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance). Geneva: CIOMS, 2012). Accessible at https://cioms.ch/
shop/product/definitions-and-applications-of-terms-for-vaccine-pharmacovigilance/.
12 An adverse event following immunization (AEFI) has been defined as any untoward medical occurrence which follows immunization
and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable
or unintended sign, abnormal laboratory finding, symptom or disease. AEFIs can be distinguished by cause as vaccine product-
related reactions, vaccine quality-related reaction, immunization error-related reaction, immunization anxiety-related reaction or be
coincidental events. (see Council for International Organizations of Medical Sciences (CIOMS). Definition and application of terms of
vaccine pharmacovigilance (report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance). Geneva: CIOMS,2012.
13 World Health Organization (WHO): Global Manual on Surveillance of Adverse Events Following Immunization. WHO Western Pacific
Regional Office, 2012.
14 Minister of Health Canada. Strategic risk communications framework for Health Canada and the Public Health Agency of Canada.
Ottawa: Minister of Health Canada, 2007. Accessible at: https://www.canada.ca/en/health-canada/corporate/about-health-canada/
activities-responsibilities/risk-communications.html.
15 Fischhoff B, Brewer NT, Downs JS. Communicating risks and benefits: an evidence-based user’s guide. Silver Spring, MD: US Food
and Drug Administration, 2009.
16 Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf. 2010,
33: 1065-1079.
17 European Medicines Agency (EMA) and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP) – Annex
II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC) Rev 1. London: EMA, 12 October
2017. Accessible at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.
jsp&mid=WC0b01ac058058f32c.
18 Communicating Risks and Benefits: An Evidence-Based User’s Guide. Published by the Food and Drug Administration (FDA), US
Department of Health and Human Services, August 2011. Available on FDA’s Web site at http://www.fda.gov/ScienceResearch/
SpecialTopics/RiskCommunication/ default.htm
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CHAPTER 2.
CONSIDERATIONS FOR VACCINE SAFETY
COMMUNICATION
Those engaged in vaccine safety communication need to have a clear understanding of their mandates,
audiences and aims (see §2.1) and cannot ignore changing contexts in which they operate, in order
to adapt for efficient achievements of the aims.
The current situation is that vaccines have been one of the most successful health interventions and
vast population groups agree with immunization,19 while at the same time there is a debate in the
public domain around the benefits and risks of vaccines, in particular when a safety concern arises,
and some groups and individuals are hesitant or reject vaccines (see §2.4).
The challenge for communication is to operate efficiently in a field of tension between public expectations
and concerns, scientific evidence and uncertainty (see §2.2). Vaccine safety communicators must
also pay careful attention to the relationship between communication, transparency and public trust
(see §2.3).
2.1.
Audiences and aims of vaccine safety
communication
The communication discussed in this report happens between regulatory authorities responsible
for the safety of vaccines as medicinal products and multiple stakeholders, including public health
authorities, immunization advisory committees, ministries of health, manufacturers with their own
responsibility for the safety of their vaccines, healthcare professionals in their intermediary role,
and the wider public. The public consists of multiple groups, including in particular those vaccinated
or for whom immunization is intended, parents, families and carers, religious, community and public
opinion leaders, healthcare professionals, whether modern or traditional, as well as journalists and
others active in the news or social media (see §5.3).
Those responsible for infectious disease control often use the social ecological model (SEM) as a
theory-based framework for understanding the multifaceted and interactive effects of personal and
environmental factors that determine the behaviours of individuals and groups.20 Without going into
detailed recommendations on how this framework could be applied to vaccine safety communication
by regulatory authorities, Figure 2.1 below shows how the SEM visualizes the complex relationships
between the stakeholders and provides a conceptual framework for regulators to create their own
local SEM and map their interactions.
19 “Immunization” as used in this report means the usage of a vaccine for the purpose of immunizing individuals. It is generally
acknowledged that (1) “immunization” is a broader term than “vaccination”, including active and passive immunization, and (2)
immunization when used strictly implies an immune response. In keeping with other key published literature in the field of immunization,
the terms “immunization” and “vaccination” are – in general – used interchangeably in the current report. (see Council for International
Organizations of Medical Sciences (CIOMS). Definition and application of terms of vaccine pharmacovigilance (report of CIOMS/WHO
Working Group on Vaccine Pharmacovigilance). Geneva: CIOMS, 2012). Accessible at: https://cioms.ch/shop/product/definitions-
and-applications-of-terms-for-vaccine-pharmacovigilance/.
20 United Nations Children’s Fund (UNICEF). What are the Social Ecological Model (SEM), and Communication for Development (C4D)?
New York: UNICEF. Accessible at: https://www.unicef.org/cbsc/files/Module_1_SEM-C4D.docx.
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Figure 2.1: The social-ecological model (SEM)21
Policy/Enabling Environment
(national, state, local laws)
Organizational
(organizations and social institutions)
Community
(relationships between organizations)
Interpersonal
(families, friends,
social networks)
Individual
(knowledge,
attitudes,
behaviors)
In the communication process, the roles of listening and speaking should alternate between
stakeholders, who should not be viewed as opponents, but as partners in an exchange over a
topic of major public interest, in order to safeguard health for individuals and as a common good.
Therefore, the common language where regulators call stakeholders and especially the general
public and its sub-populations ‘audiences’ could be misleading if that would be understood as those
expected to listen without having a voice of their own. The term ‘audience’ is used in this report to
refer to those whom vaccine safety communication systems are supposed to serve, above all the
public as a whole, its sub-populations, and its individual members, healthcare professionals and
health policy decision-makers.
Any party, subgroups or individuals may take particular roles in shaping knowledge, attitudes,
practices (KAP) of individuals and groups, but in particular opinion leaders in healthcare, community
and religious leaders, journalists, trusted governmental or nongovernmental organizations, and interest
groups like anti-vaccine groups, women’s groups or citizen watchdog groups. An opinion leader can
also come from outside a concerned community or country.
In line with the mandate of regulatory bodies to assess and licence medicines and continuously
assess and supervise medicines after licensure, regulatory vaccine safety communication with
stakeholders may benefit from having the following communication aims:
21 United Nations Children’s Fund (UNICEF). What are the Social Ecological Model (SEM), and Communication for Development (C4D)?
New York: UNICEF. Accessible at: https://www.unicef.org/cbsc/files/Module_1_SEM-C4D.docx. UNICEF adapted their model from
the Centers for Disease Control and Prevention (CDC), The Social Ecological Model: A Framework for Prevention, http://www.cdc.
gov/violenceprevention/overview/social-ecologicalmodel.html.
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f
f understanding KAP and related concerns and information needs (and ideally underlying mental
models)22 of the audiences with regard to vaccines;
f
f providing accurate and full information about the safety profiles and benefit-risk balances of
vaccine products for supporting informed choice of individuals and policy-makers in relation to
immunization;
f
f demonstrating trustworthiness of the vaccine safety surveillance system (pharmacovigilance)
for trust-building; and
f
f preventing and managing crisis situations due to safety concerns over vaccines.
A sub-objective is to provide the information in formats that may support healthcare professionals
and vaccinators when communicating with individuals, such as (potential) vaccines (people
receiving vaccinations), carers and community leaders. Communication in the public domain
impacts on interpersonal communication between individuals in healthcare settings, as it occurs
(e.g. when discussing informed consent for study participation, proposed vaccination of children,
or suspected harm due to a vaccine).
2.2.
Communicating evidence and uncertainties for
informed decision-making
The issue of the general individual freedom of choice in life – versus the need for certain behaviours for
community good – bears potential for conflict. From a perspective of communication and increasingly
shared medical decision-making23 and community participation, the concept of informed choice about
whether to vaccinate or not is widely accepted. Informed choice and the related informed consent
are complex concepts and far more demanding than is often understood. There is complexity in the
scientific issues and how to communicate them in a way generally understandable as well as in the
psychological, political and religious factors of individuals and groups. Informed choice can arise
only when the questions, doubts, preoccupations and emotional needs of individuals and groups are
accurately addressed, probably over a long period of time. Even when such concerns are accurately
addressed, there may still be vaccine refusal, a decision entirely within the rights of individuals in
countries where the ethical principle of voluntariness is upheld. Choice will arise from a multiplicity
of influences with scientific evidence maybe playing a quite minor part, but for informed choice clear
communication of the evidence is essential.
Intrinsic to the scientific approach is to acknowledge that each piece of evidence is surrounded by
uncertainty to some degree, depending on the robustness of the evidence. In addition evidence can
also raise new questions and detect areas of missing knowledge. While the most important step
is to generate evidence to reduce uncertainty in important areas, decisions will always have to be
taken despite some uncertainty.
Communication for risks is therefore only complete with its evidence-base and honesty over remaining
uncertainties, and should at the same time prevent undue amplification of risk perception in society.
Communication interventions can clarify what is known and what is unknown, what confidence one can
have in the robustness of existing knowledge and the current plausibility and relevance of potential
unknown issues. Guidance on how to address uncertainty is summarized in Guidance Summary 2.2.
22 Amentalmodelcorrespondstobeliefs,inwhichknowledge,uncertaintiesandunknownsgetmerged.Newinformationisprocessedwithin
a mental model, and this process is called perception [See Morgan MG, Fischhoff B, Bostrom A, and Atman CJ. Risk communication:
a mental models approach. Cambridge: Cambridge University Press, 2002. and Slovic P. The feeling of risk: new perspectives on
risk perception. London, Washington DC: Earthscan, 2010.]
23 Elwyn G, Edwards A, Thompson R. Shared decision making in health care. 3rd ed. Oxford: Oxford University Press, 2016.
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Guidance Summary 2.2: Addressing uncertainty in vaccine safety
From the report on a United States Institute of Medicines (IOM) workshop dedicated to
communicating uncertainty in relation to pharmaceutical products24, principles for communicating
uncertainty in relation to the safety of vaccines can be derived and adapted as follows:
f
f Gain clarity over the type of uncertainty such as:
—
— statistical uncertainty or other methodological limitations of existing evidence,
—
— uncertainty based on surrogate primary outcomes (e.g. antibody development, or,
for HPV vaccines, development of genital lesions and warts as surrogate outcome
for cervical cancer risk),
—
— uncertainty due to novelty of the vaccine product and early stage of evidence gathering
under real conditions of vaccine use, and
—
— uncertainty based on limited evidence at early stage of detecting a signal of a rare
potential adverse effect of a vaccine, as the type of uncertainty defines the communication
content with regard to uncertainty;
f
f Acknowledge the dynamics of scientific evidence as well as:
—
— the complexity of benefit-risk assessment
—
— the decision-making processes for regulatory licensure and individual patients, including
—
— the need for interpretation of available and missing data;
f
f Listen to views of the public and explore values of society, in order to establish:
—
— principles,
—
— thresholds of risk tolerance and
—
— benefit-risk trade-offs for decision-making in situation of uncertainty;
f
f Foster transparency about:
—
— robustness of evidence,
—
— type of uncertainties,
—
— sensitivity analysis of different possible scenarios of areas where data is missing and
—
— decision-making, including about
—
— how convergence is reached between experts or how divergent views have been
addressed;
f
f Demonstrate, towards the public, commitment and quality assuring processes to achieve
best possible decisions for individual and public health as the outcome of the benefit-risk
assessment in situations of uncertainty and focus on thereby earning trust.
24 US Institute of Medicine (IOM). Characterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical
products – workshop summary. Washington, DC: The National Academies Press, 2014.
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2.3.
Transparency for honest communication and
public trust-building
In this respect, it is stressed that communication, no matter how skilful and carefully designed, cannot
and is not meant to disguise any lack of evidence or uncertainty or flaws in the processes of safety
surveillance, risk management or regulatory decision-making. The link between communication and
transparency is vital.
Further, a prerequisite to the effectiveness of the communication is that the regulatory authority as
the sender of information is trusted as an evidence-based, honest and credible organization known
for its integrity, and that the trustworthiness of the vaccine safety surveillance (pharmacovigilance)
system is well demonstrated. Guidance on how to build trust in the area of vaccine safety is provided
in Guidance Summary 2.3, and is illustrated by Example 2.3.
Guidance Summary 2.3: Building trust in vaccine safety
A report of the European Centre for Disease Prevention and Control (ECDC)25 on building trust
in immunization programmes and the Vaccine Confidence Project at the London School of
Hygiene & Tropical Medicine26 has been used as the basis for the following recommendations
for regulatory authorities for building trust in the area of vaccine safety:
f
f Engage in transparency;
f
f Build professional-personal relationships with all stakeholders (see §5.3) over time and
specifically at local and ‘grass root’ level for a multistakeholder dialogue;
f
f Apply the stepwise communication process with monitoring of knowledge, attitudes,
practices (KAP) (see §2.1) and related concerns and information needs;
f
f Foster the participation of all parties in the vaccine assessment and communication
processes to ensure that public concerns are listened to and are taken seriously;
f
f Target specifically vaccine-hesitant groups (see §2.4) and those who are undecided and
need information;
f
f Pay attention to building trust in the safety processes for the vaccines within the healthcare
sector, as providers need to feel confident that they are recommending safe and effective
vaccines and can confidently answer the growing questions from parents;
f
f Approach community, religious and political leaders and establish cooperation on vaccine
matters (note that when excluded, such leaders can become barriers to public trust);
f
f Explain to the public how personal data accruing from these processes are protected;
f
f Understand barriers to trust in your environment and find solutions to overcome these
barriers;
f
f Think beyond the vaccine and consider the historical as well as the current societal and
political factors that could influence public trust;
f
f Communicate with the public on a new vaccine or a new vaccine safety concern proactively
and continuously, in order to avoid:
25 European Centre for Disease Prevention and Control (ECDC). Communication on immunisation: building trust. Stockholm: ECDC,
2012. Accessible at: http://ecdc.europa.eu/en/publications/Publications/TER-Immunisation-and-trust.pdf.
26 London School of Hygiene & Tropical Medicine. The Vaccine Confidence Project; Accessible at: www.vaccineconfidence.org.
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—
— information vacuums in the public domain and room for speculations and misleading
rumours, and
—
— appearing passive and late in investigations and health protection;
f
f Be prepared for immediate communication in response to queries from the public;
f
f Be honest in providing information and do not hide uncertainties (see §2.2);
f
f Add to the key messages bridging information that can connect the new information with
the mental models and KAP (see §2.1) prevalent in the public;
f
f Keep consistency between messages and explain changes and how new information links
with what was known before;
f
f Monitor media debates and, in case of misinformation, provide input to debates with
corrective information;
f
f When countering a negative rumour or misleading information, consider the ‘fertile ground’
factors that make the rumour popular in the first place and address those in addition to
providing corrective information;
f
f Consider participating in the certification of the WHO’s Global Advisory Committee on
Vaccine Safety (GACVS) website: Vaccine Safety Net portal for websites that provide
information on vaccine safety and adhere to good information practices (http://www.
vaccinesafetynet.org/);27
f
f Always be non-judgmental and do not dismiss public concerns because they are based on
belief instead of evidence. Where religious beliefs are involved, find ways to make vaccines
acceptable within the given religious belief;
f
f When engaging and communicating with the public, be respectful and express commitment
through the tone of messages.
Specific guidance on partnering with religious leaders and groups has been made available by UNICEF.28
Example 2.3: Re-building trust in the MMR vaccine in the United Kingdom
Starting in 1996, a group based at the Royal Free Hospital, London, United Kingdom (UK)
published a series of articles in scientific journals that purported to show variously that measles
virus, measles vaccine and measles-mumps –rubella (MMR) vaccine were respectively associated
with inflammatory bowel disease and autism. Despite the lack of any credible evidence linking
the measles virus and measles vaccine with bowel disease, nor the MMR vaccine with bowel
disease and autism, the single measles vaccine was advised by health officials as an alternative.
Despite these fundamental illogicalities, each pronouncement was given considerable media
credibility supported by parents and lawyers who were seeking compensation.
27 World Health Organization (WHO). Vaccine safety net. Accessible at: http://www.who.int/vaccine_safety/initiative/communication/
network/vaccine_safety_websites/en/.
28 United Nations Children’s Fund (UNICEF). Building trust in immunization: partnering with religious leaders and groups. New York:
UNICEF; 2004. Available at: https://www.unicef.org/publications/index_20944.html.
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The consequence was rapid erosion of trust in the safety of MMR by parents and healthcare
professionals. Before the onset of fears over MMR vaccine safety, vaccine coverage had
been more than 90% by the second birthday. Measles had been eliminated from the UK.
Coverage fell progressively to a national average of less than 80% with coverage of less than
70% in some localities, especially in London. Small outbreaks of measles were restricted by
the previous high population immunity. Much research amongst parents showed that whilst
they were concerned about the safety of MMR, they were not concerned about the potential
seriousness of measles.
MMR uptake at 16 months and
proportion of mothers believing in complete
or almost complete safety of MMR vaccine
MMR uptake
% mothers confident
60%
70%
80%
90%
A
p
r
–
9
4
A
p
r
–
9
5
A
p
r
–
9
6
A
p
r
–
9
7
A
p
r
–
9
8
A
p
r
–
9
9
A
p
r
–
0
0
A
p
r
–
0
1
A
p
r
–
0
2
A
p
r
–
0
3
Crohn’s paper Autism paper
Sustained negative
media reportage
+ Leo Blair
Source: graphic provided with permission by Davis Salisbury, Global Health Security, Chatham
House, London.29
29 David Salisbury, Centre for Global Health Security, Chatham House, London UK, through email 12 Feb 2016 provided as a PowerPoint
slide in document, with reference to presentation by Jo Yarwood, UK Department of Health, Public Health England, 23 October 2012.
Yarwood credits on slide 15: Thanks to Prof. Brent Taylor, Community Child Health at the Royal Free and University College Medical
School, London, https://www.slideshare.net/meningitis/jo-yarwood-informing-the-public-about-immunisation.
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Such interpretation was entirely rational in the face of repeated media reports raising fears
over the MMR vaccine and autism and in the light of measles having been eliminated. Research
also showed that the most trusted sources of health advice were local providers – general
practitioners, practice nurses and health visitors. The UK Department of Health’s communication
strategy was built therefore on ensuring that those providing advice had the best information
readily available to give to parents and to ensure that parents could also easily access sources
of trustworthy material. For the former, a suite of materials was developed and tested that
addressed concerns from the least to the most literate, readily available in hard copy or online,
for the latter. The website “MMR – The Facts”30 was accessed frequently. It was updated
whenever new information became available and was much valued by parents and journalists.
Probably, the most telling event in the turnaround of opinion was the work of the investigative
journalist, Brian Deer. His reports, and website, revealed much of the hitherto unknown background
of the research probity leading to an investigation by the UK General Medical Council with the
consequence of the removal of the licence to practice of the lead protagonist on the grounds
of serious professional misconduct, including ‘acting dishonestly and irresponsibly.’ From this
point onwards, public opinion and indeed the reporting by journalists changed considerably.
MMR vaccine coverage has quietly and consistently risen to its present levels – back over 90%.31
For communication, it is fundamental to understand the concept of transparency.
Transparency refers to an organization’s openness about its activities, providing reliable and timely
information that is accessible and understandable on what it is doing, where and how its activities take
place, and how the organization is performing, unless the information is deemed confidential.32 This
should include conflict of interest declarations of those involved in assessment and decision‑making
30 UK Government Web Archive. NHS Immunisation Information. The Science and history of immunisation and about the vaccines in the
routineUKimmunisationschedule.MMRTheFacts.Archivedon5Jul2009http://webarchive.nationalarchives.gov.uk/20090705184233/
http://www.immunisation.nhs.uk/Vaccines/MMR
31 Example provided by David Salisbury, Centre for Global Health Security, Chatham House, London, United Kingdom.
32 World Health Organization (WHO). WHO accountability framework. Geneva: WHO, 2015.
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as well as documentation how these are managed to avoid partiality, bias and perceptions of undue
commercial influence.33
While both communication and transparency processes make information available to the public,
they are distinguished by their objectives: transparency serves accountability over decision-
making; communication aims at behaviours34 – here the informed and safe vaccination behaviours.
Communication and transparency are however linked, because transparency of the communicating
organization demonstrates its trustworthiness – provided it meets the expected standards for vaccine
assessment – and this makes the communication more effective.35
In the area of vaccine safety, transparency of regulatory authorities should make information, such as
assessment reports and meeting minutes, available to the public, as much as possible proactively and
otherwise upon request. This will allow the public to better understand the data gathering process,
as well as the licensing, risk assessment and decision-making processes in which stakeholders are
involved. By being transparent, authorities can clarify a situation to the public, acknowledge their
concerns and provide relevant information about issues where the public has limited knowledge.36
Policies need to be in place to assure confidentiality of personal data and the quality of the documents
made available to the public.
2.4.
Perceptions of risk as a trigger of vaccine
hesitancy
Vaccine hesitancy is seen in low, middle and high-income countries around the globe. The term refers
to delaying acceptance of or refusing vaccines that are on offer. Vaccine hesitancy is complex and
situation-specific, varying across time, place and vaccine products.37 Although the term vaccine
hesitancy has been widely adopted to describe behaviour critical of or hostile to vaccination, it is
a catch-all category rather than a coherent concept.38 It presumes to cover a very wide range of
attitudes and behaviours, influenced by multiple and differential causes and sources, both within
individuals and across populations. It seems to imply an unspecified point on a spectrum from
extreme opposition to full acceptance, a point which may not represent truly the entire position of
an individual or society as a whole. It does not, for example, easily include at the same time the
knowledgeable, vaccine-favouring individual or parent who has questions or doubts about a specific
vaccine, the parent critically opposed to all vaccines and the generally ill-informed or difficult-to-
reach parent whose children are not brought forward for immunization. For the time being, however,
this report refers to the term vaccine hesitancy as a shortcut for this range of underlying knowledge,
attitudes, practices (KAP) and related concerns and information needs.
Vaccine hesitancy arises in a complex matrix of events and influences, including the proliferation
of news and social media as well as website of organizations in the internet, reliable or dubious,
33 European Centre for Disease Prevention and Control (ECDC). Communication on immunisation: building trust. Stockholm: ECDC;
2012. Accessible at: http://ecdc.europa.eu/en/publications/Publications/TER-Immunisation-and-trust.pdf.
34 Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf. 2010,
33: 1065-1079.
35 Slovic P. Perceived risk, trust and democracy. In: Cvetkovich G, Löfstedt RE, eds. Social trust and the management of risk. London:
Earthscan, 1999: 42-52.
36 European Centre for Disease Prevention and Control (ECDC). Communication on immunisation: building trust. Stockholm: ECDC;
2012. Accessible at: http://ecdc.europa.eu/en/publications/Publications/TER-Immunisation-and-trust.pdf.
37 Larson HJ, Jarret C, Eckersberger E, Smith DM, Paterson P. Understanding vaccine hesitancy around vaccines and vaccination from
a global perspective: a systematic review of published literature, 2007-2012..
38 Peretti-Watel P, Larson HJ, Ward JK, Schulz WS, Verger P. Vaccine hesitancy: clarifying a theoretical framework for an ambiguous
notion. PLOS Currents Outbreaks. 2015 Feb 25 . Edition 1.
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of variable quality and often confusing or contradictory. There are many complex and wide-ranging
reasons for negative sentiments towards vaccines and vaccine hesitancy (see Figure 2.4), and amongst
them concerns over safety are a major reason for vaccine hesitancy.39
Figure 2.4: The WHO Strategic Advisory Group of Experts (SAGE) on Immunization
Model of determinants of vaccine hesitancy40
Vaccine hesitancy may however also come from a general climate of mistrust that is not specific
to vaccines, but linked to lack of trust in governments, industry, or science. Among populations in
resource-limited countries, some vaccine hesitancy could be related to suspicions of the motivation
of donors to or foreign programme management of immunization campaigns. What is often also
overlooked is that vaccine hesitancy may be understood, in some situations, as the other side of
simultaneously present positive sentiments towards vaccines, i.e. expectations that they bring benefits
39 Larson HJ, Jarret C, Eckersberger E, Smith DM, Paterson P. Understanding vaccine hesitancy around vaccines and vaccination from
a global perspective: a systematic review of published literature, 2007-2012..
40 Larson HJ, Jarret C, Eckersberger E, Smith DM, Paterson P, 2007-2012.
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and should not harm.41 Some argue that high expectations of vaccines may lead to heightened
awareness and frustration over risks.42
Vaccine sentiments, acceptance and hesitancy are not static but may change as their determinants
change over time or suddenly, or as a serious vaccine-preventable disease arises newly or changes
in its incidence or severity, due to or independently from immunization. There is a specific potential
for vaccine hesitancy when the public perception of the risk of the disease is low. In particular when
diseases have become rare as the result of immunization programmes (e.g. measles, polio) and
the public has little first-hand experience of the targeted diseases, perceptions of vaccine risks
may be heightened in comparison to the risks of the disease. This contributes to the challenges of
vaccine safety communication. On the other hand, when vaccines are perceived to be effective in
preventing diseases that people are afraid of, vaccine acceptability can increase. Insufficient vaccine
availability may then become an issue, prompting the need to communicate difficult decisions about
prioritization of immunization target populations.
Vaccine hesitancy is not new,43 and there are as number of examples from different parts of the
world where vaccine introduction was rejected en masse by the population intended to benefit from it
(e.g. the “Revolt da vacina” in Brazil in 190444 and HPV vaccine rejection by mothers in Romania45).
In another example, religious or political leaders intervened in northern Nigeria46 and Pakistan47 to
hinder the polio vaccine immunization programmes. Individual (as opposed to en masse) vaccine
hesitancy, though collectively generating large numbers, appears currently to be a feature of high-
income countries.
As the contexts of vaccine hesitancy vary enormously from region to region and from country to
country, no comprehensive solution can be proposed. The underlying principle of any solution, however,
lies in sensitive and empathic engagement and communication with individuals and communities
based on an authentic understanding of the sentiments and concerns of multiple segments of the
population, in particular those where doubt, resistance, mistrust or hostility is held. Comprehensive,
transparent and comprehensible evidence-based safety information is a critical element of the process,
but only a part. Working on trust-building is essential too (see §2.3). However, vaccine hesitancy can
be addressed, and Guidance Summary 2.4 provides advice about how regulatory authorities can
contribute. While reaching out to vaccine-hesitant populations falls under the remit of the public health
agencies and immunization programmes, as described in Example 2.4.1, regulatory authorities can
support their efforts with providing information about vaccine safety and vaccine pharmacovigilance
systems (see Chapter 3). In return they can use the in-depth audience insights of the immunization
programmes, in order to ensure that the information needs of all sub-audiences are fulfilled.
41 Leach M, Fairhead J. Vaccine Anxieties: global science, child health and society. London: Taylor & Francis Earthscan; 2007.
42 Leach M, Fairhead J. 2007.
43 The College of Physicians of Philadelphia. History of anti-vaccination movements. Philadelphia, PA: The College of Physicians of
Philadelphia ; 2017. Accessible at: https://www.historyofvaccines.org/content/articles/history-anti-vaccination-movements.
44 Hochman G. Priority, Invisibility and Eradication: The History of Smallpox and the Brazilian Public Health Agenda. Medical History.
2009, 53(2):229-252.
45 Craciun C, Baban A. Who will take the blame?: understanding the reasons why Romanian mothers declined HPV vaccination for their
daughters. Vaccine. 2012; 30: 6789-6793.
46 Ghinai I, Willott C, Dadari I, Larson HJ. Listening to the rumours: what the northern Nigeria polio vaccine boycott can tell us ten years
on. Glob Public Health. 2013; 8: 1138–1150. Accessible at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4098042/.
47 Walsh D. Polio crisis deepens in Pakistan. New York Times. 26 Nov 2014. Accessible at: https://www.nytimes.com/2014/11/27/
world/asia/gunmen-in-pakistan-kill-4-members-of-anti-polio-campaign.html?_r=0.
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Guidance Summary 2.4: Addressing vaccine hesitancy
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization has reviewed and
identified strategies to address vaccine hesitancy. Based on these strategies,48 the following
recommendations have been formulated for regulatory authorities:
f
f Aim to increase knowledge and awareness surrounding vaccine safety, efficacy and quality,
safe use advice and pharmacovigilance;
f
f Tailor the intervention to the relevant populations and their specific concerns or information
gaps, including those which are discussed by vaccine-hesitant groups;
f
f Interact with local communities and healthcare professionals and engage with influential
leaders, including religious leaders;
f
f Introduce education initiatives, particularly those that embed new knowledge into tangible
health outcomes;
f
f Employ multi-component communication and follow-ups as needed.
In general, interventions that are applicable to the individual only from a distance (e.g. posters,
websites, media releases, and radio announcements) have some, but usually smaller benefit
than closer, personal interactions. However, the application of mass media to target parents
with low levels of health service awareness still appears to have a valid place in effective
communication, and there is good potential for a true positive effect across a larger population.
Example 2.4.1: Overcoming hesitancy against the MMR vaccine in sub-populations
in Sweden
Two groups in the Swedish population have previously been identified as hard-to-reach for
measles-mumps-rubella (MMR) immunization, based on documented low vaccination coverage:
the anthroposophic community in Järna and the Somali community in Rinkeby and Tensta.
The vaccination coverage among 2-year-olds in 2012 in both these communities was low (4.9%
in Järna, 69.7% in Tensta and 71.5% in Rinkeby) compared to the national average of 97.2%.
Järna is a suburb south of Stockholm with a population of about 7,000 people and about
140–150 births per year. A portion of the population follows a lifestyle based upon the
philosophies of Rudolf Steiner who advocated for a holistic view of health with particular
views regarding food, health, and education. Many people practicing an anthroposophic way
of life are hesitant towards MMR vaccination, because they believe that a measles infection is
good for the child’s physical and mental health development. Several outbreaks of measles
and rubella have occurred in Järna and in nearby areas in recent years. In 2012, 23 cases of
measles and 50 cases of rubella were reported as originating from Järna.
Rinkeby and Tensta are districts located in the northwest part of Stockholm with a high
percentage of residents with foreign backgrounds, with 30% of the population of Somali origin.
In 2013, the population in the Rinkeby district was 16,047 people, including 1,638 children
under five years old (8.9%), and in Tensta the population was 18,866 people, including 1,673
children under five years old (10.2%). In these regions, repeated studies have revealed that
Somali women in the area do not want to vaccinate their children against MMR, because they
believe that the vaccine can cause autism.
48 Jarret C, Wilson R, O’Leary M, Eckersberger E, Larson HJ; SAGE Working Group on Vaccine Hesitancy. Strategies for addressing
vaccine hesitancy: a systematic review. Vaccine 2015; 33: 4180-4190. .
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As a response, the public health agency of Sweden used a tool developed by WHO Europe
called Tailoring Immunization Programmes (TIP). The aim of TIP is to identify and increase the
knowledge state about vaccines in groups with low vaccination coverage. The TIP methods
are based on behavioural theories and planning models for health programmes, including
social marketing and communication, with focus on behavioural change. TIP includes both an
analysis method to understand the interests, characteristics and needs of different population
groups and individuals in a society as well as tools to support the work of national immunization
programmes with the goal of designing targeted strategies that increase acceptance of
immunization.
The results of the TIP analysis in Sweden revealed that communication strategies needed to
be strengthened at the local and individual level in these areas with low vaccination coverage
and that these interventions should be carried out for an extended period of time. Furthermore,
communication with healthcare professionals was considered essential to provide them with
relevant and evidence-based information about vaccines as well as about the people’s attitudes
toward them. Parents from the anthroposophic and Somali communities requested neutral
information about the benefits and risks of vaccines and an objective dialogue with healthcare
professionals. The Swedish public health agency proposed several targeted communication
and education initiatives, including a peer-to-peer project, in-depth educational interventions
in vaccinology for healthcare professionals and targeted information about the importance of
being vaccinated with MMR before travelling abroad.
In their conclusions, the public health agency noted that the project has provided a foundation
and guidance for the continued work in communicating about MMR immunization. 49, 50, 51
As vaccine hesitancy can be triggered by safety concerns, it is helpful to understand how cognitive
factors impact on perceptions of risk. This understanding can also be useful for communication
planning and preparedness. The cognitive and psychological decision-making sciences have identified
a number of characteristics of risks, so-called cognitive factors, which may increase the perception
of risk of individuals and groups. These include that a risk may be involuntary, imposed, novel, man-
made, related to technology or result in a dreadful outcome, in particular after a long latency period.
Other factors relate to a risk being subject to uncertainty, scientific controversy or public debate.
The most powerful factors are present when a risk possibly concerns women, children, sexuality,
reproduction and future generations, or is illustrated by identifiable victims and personal stories.52
Research has also shown that cognitive factors can lead to what is called social risk amplification, i.e.
a perception of heightened risk, often triggered by debate in groups or society as a whole.53 Where
cognitive factors are present, the need for well-prepared and conducted risk communication early on
prior to licensure/launch and throughout the life-cycle of a vaccine can be predicted. Example 2.4.2
demonstrates how applying these findings from risk psychology can help in prioritization efforts in
49 Folkhälsomyndigheten. Barriers and motivating factors to MMR vaccination in communities with low coverage in Sweden: implementation
of the WHO’s Tailoring Immunization Programmes (TIP) method. Solna: Folkhälsomyndigheten,2015. Accessible under: https://www.
folkhalsomyndigheten.se/pagefiles/20261/Barriers-motivating-factors-MMR-vaccination-communities-low-coverage-Sweden-15027.pdf.
50 Byström E, Lindstrand A, Likhite N, Butler R, Emmelin M. Parental attitudes and decision-making regarding MMR vaccination in an
anthroposophic community in Sweden: a qualitative study. Vaccine. 2014, 32: 6752-6757.
51 Example provided b yChandler R, Uppsala Monitoring Centre (UMC), Sweden, confirmed through personal communication 10 February
2016.
52 Bennett P. Understanding responses to risk: some basic findings. In: Bennett P, Calman K. Risk communication and public health.
Oxford: Oxford University Press; 1999. (Quoting Fischhhoff B, Slovic P, Lichtenstein S, Read S, Coombes B. How safe is safe enough?:
a psychometric study of attitudes towards technological risks and benefits. Policy Science. 1978, 9: 127-152.; Gardner GT, Gould
LC. Public perceptions of risks and benefits of technology. Risk Analysis. 1989, 9: 225-242.; Slovic P. Informing and educating about
risks. Risk Analysis. 1986, 6: 403-415.)
53 Kasperson RE, Renn O, Slovic P, Brown HS, Emel J, Goble R, et al. The social amplification of risk: a conceptual framework. Risk
Analysis. 1988, 8: 177-187.
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the area of vaccines. While a number of cognitive factors are present in many vaccines, some are
specific to certain vaccines.
Example 2.4.2: The need for understanding public concerns over HPV vaccines
prior to licensure and launch
Vaccines against the human papillomavirus (HPV) were licensed as of 2006 and the public
debate prior to their licensure and launch in various countries of the world demonstrates the
relevance of understanding cognitive factors in vaccine safety communication, to enable
addressing concerns pro-actively through risk assessment and communication.
Research has identified a number of cognitive factors that have the potential to increase risk
perception in a society. These factors include relatedness of a topic to children, women,
sexuality, reproduction and future generations.54 Given the transmission of HPV through sexual
body contact and given the protection against cervical cancer as the major objective of HPV
immunization in adolescents, the factors children/women and sexuality, and subsequently
reproduction and future generations were obviously present in the case of HPV vaccines from
the onset. The initial immunization strategy focusing exclusively on girls further reinforced
the social amplification of risk perception.55 The media in some countries also portrayed the
vaccine as “experimental”.56 Novelty, uncertainty and scientific debate are further cognitive
factors increasing risk perception.57 On the whole, the presence of cognitive factors for HPV
vaccines was predictive of the need for a specific and careful communication strategy.
In the scientific as well as general media concerns were raised indeed over benefit, i.e. vaccine
effectiveness long-term, effects on natural immunity, future HPV strain replacement,58, 59, 60, 61,
62, 63 as well as over safety.64 Safety concerns discussed in many different countries related
54 Bennett P. Understanding responses to risk: some basic findings. In: Bennett P, Calman K. Risk communication and public health.
Oxford: Oxford University Press; 1999. (Quoting Fischhhoff B, Slovic P, Lichtenstein S, Read S, Coombes B. How safe is safe enough?:
a psychometric study of attitudes towards technological risks and benefits. Policy Science. 1978,9: 127-152.; Gardner GT, Gould
LC. Public perceptions of risks and benefits of technology. Risk Analysis. 1989, 9: 225-242.; Slovic P. Informing and educating about
risks. Risk Analysis. 1986; 6: 403-415.)
55 Thompson M. Who’s guarding what? – a post-structural feminist analysis of Gardasil discourses. Health Commun. 2010, 25: 119-130.
56 Rondy M, van Lier A, van de Kassteele J, Rust L, de Melker H. Determinants for HPV vaccine uptake in the Netherlands: A multilevel
study. Vaccine. 2010,28: 2070-2075.
57 Bennett P. Understanding responses to risk: some basic findings. In: Bennett P, Calman K. Risk communication and public health.
Oxford: Oxford University Press; 1999. (Quoting Fischhhoff B, Slovic P, Lichtenstein S, Read S, Coombes B. How safe is safe enough?:
a psychometric study of attitudes towards technological risks and benefits. Policy Science. 1978, 9: 127-152.; Gardner GT, Gould
LC. Public perceptions of risks and benefits of technology. Risk Analysis. 1989, 9: 225-242.; Slovic P. Informing and educating about
risks. Risk Analysis. 1986; 6: 403-415.)
58 Rondy M, van Lier A, van de Kassteele J, Rust L, de Melker H. Determinants for HPV vaccine uptake in the Netherlands: A multilevel
study. Vaccine. 2010, 28: 2070-2075.
59 Gerhardus A, Razum O. A long story made too short: surrogate variables and the communication of HPV vaccine trial results. J
Epidemiol Community Health. 2010, 64: 377-378.
60 Nghi NQ, Lamontagne DS, Bingham A, Rafiq M, Mai le TP, Lien NT, Khanh NC, Hong DT, Huyen DT, Tho NT, Hien NT. Human
papillomavirus vaccine introduction in Vietnam: formative research findings. Sex Health. 2010, 7: 262-270.
61 Rothman SM, Rothman DJ. Marketing HPV vaccine: implications for adolescent health and medical professionalism. J Am Med Assoc.
2009, 302: 781-786.
62 Sherris J, Friedman A, Wittet S, Davies P, Steben M, Saraiya M. Education, training, and communication for HPV vaccines. Vaccine.
2006, 24 Suppl 3: S3 210-218 (chapter 25).
63 Tafuri S, Martinelli D, Vece MM, Quarto M, Germinario C, Prato R. Communication skills in HPV prevention: an audit among Italian
healthcare workers. Vaccine. 2010, 28: 5609-5613.
64 Friedman AL, Shepeard H. Exploring the knowledge, attitudes, beliefs, and communication preferences of the general public regarding
HPV: findings from CDC focus group research and implications for practice. Health Educ Behav. 2007, 34: 471-485.
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to the exposure of “young girls”,65 to the burden of “too many vaccines”,66 and to the potential
for adverse reactions,67, 68, 69, 70 fatal outcomes71 and long-term safety.72 A specific concern
was voiced about the impact of the vaccine on female fertility.73 In low resource healthcare
settings concerns over vaccine product quality, use of expired products and unsafe injection
added to the fears.74 Beyond quality and safety, social concerns arose that HPV immunization
would increase early and multi-partner sexual activity.75, 76, 77
In any case, communicating about HPV immunization requires addressing intimate matters
with young people, including whether sexual activity has started or not, and this constitutes
a communication challenge in and of itself.78 Some of the initial public concerns could in the
meantime be addressed by evidence from long-term and real-life research in the period after
licensure and launch of the HPV vaccines.79 Also an increase of unsafe sexual activity or
negative pregnancy outcomes could be refuted.80, 81
One might wonder if despite all the awareness one had or could have had with looking at the
HPV vaccine launch from a cognitive factors perspective, whether communication strategies
at launch were optimal in all countries and in particular whether they supported adequately
healthcare professionals (HCPs). HCPs might have felt pretty alone with all the questions raised
in the public domain, having to talk to young people about intimate matters and overcoming
vaccine anxiety of individuals arising from both these constellations. HCPs need most certainly
to be provided with in-depth information from the vaccine development phase onwards, as they
often prefer to form their own conclusions. Nowadays researches get increasingly involved in
surveys prior to HPV vaccination programs to inform the information campaigns.82
65 Tafuri S, Martinelli D, Vece MM, Quarto M, Germinario C, Prato R. Communication skills in HPV prevention: an audit among Italian
healthcare workers. Vaccine. 2010, 28: 5609-5613.
66 Sherris J, Friedman A, Wittet S, Davies P, Steben M, Saraiya M. Education, training, and communication for HPV vaccines. Vaccine.
2006, 24 Suppl 3: S3 210-218 (chapter 25).
67 Bingham A, Drake JK, LaMontagne DS. Sociocultural issues in the introduction of human papillomavirus vaccine in low-resource
settings. Arch Pediatr Adolesc Med. 2009, 163: 455-461.
68 Brown EC, Little P, Leydon GM. Communication challenges of HPV vaccination. Fam Pract. 2010, 27: 224-229.
69 Chow SN, Soon R, Park JS, Pancharoen C, Qiao YL, Basu P, Ngan HY. Knowledge, attitudes, and communication around human
papillomavirus (HPV) vaccination amongst urban Asian mothers and physicians. Vaccine. 2010, 28: 3809-3817.
70 Rondy M, van Lier A, van de Kassteele J, Rust L, de Melker H. Determinants for HPV vaccine uptake in the Netherlands: A multilevel
study. Vaccine. 2010, 28: 2070-2075.
71 Nghi NQ, Lamontagne DS, Bingham A, Rafiq M, Mai le TP, Lien NT, Khanh NC, Hong DT, Huyen DT, Tho NT, Hien NT. Human
papillomavirus vaccine introduction in Vietnam: formative research findings. Sex Health. 2010, 7: 262-270.
72 Brown EC, Little P, Leydon GM. Communication challenges of HPV vaccination. Fam Pract. 2010, 27: 224-229.
73 Nghi NQ, Lamontagne DS, Bingham A, Rafiq M, Mai le TP, Lien NT, Khanh NC, Hong DT, Huyen DT, Tho NT, Hien NT. Human
papillomavirus vaccine introduction in Vietnam: formative research findings. Sex Health. 2010, 7: 262-270.
74 Bingham A, Drake JK, LaMontagne DS. Sociocultural issues in the introduction of human papillomavirus vaccine in low-resource
settings. Arch Pediatr Adolesc Med. 2009, 163: 455-461.
75 Friedman AL, Shepeard H. Exploring the knowledge, attitudes, beliefs, and communication preferences of the general public regarding
HPV: findings from CDC focus group research and implications for practice. Health Educ Behav. 2007, 34: 471-485.
76 Sherris J, Friedman A, Wittet S, Davies P, Steben M, Saraiya M. Education, training, and communication for HPV vaccines. Vaccine.
2006, 24 Suppl 3: S3 210-218 (chapter 25).
77 Tafuri S, Martinelli D, Vece MM, Quarto M, Germinario C, Prato R. Communication skills in HPV prevention: an audit among Italian
healthcare workers. Vaccine. 2010, 28: 5609-5613.
78 Brown EC, Little P, Leydon GM. Communication challenges of HPV vaccination. Fam Pract. 2010, 27: 224-229.
79 World Health Organization (WHO). Global Advisory Committee on Vaccine Safety Statement on safety of HPV vaccines. Genève: WHO,
17 December 2015. Accessible under: http://www.who.int/vaccine_safety/committee/topics/hpv/en/.
80 Vázquez-Otero C. Dispelling the myth: exploring associations between the HPV vaccine and inconsistent condom use among college
students. Prev Med. 2016, 93: 157-150.
81 Hansen BT. No evidence that HPV vaccination leads to sexual risk compensation. Hum Vaccin Immunother. 2016, 12: 1451-1453.
82 Example provided by Priya Bahri, European Medicines Agency (EMA).
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CHAPTER 3.
PRODUCT LIFE-CYCLE MANAGEMENT
APPROACH TO VACCINE SAFETY AND
COMMUNICATION
3.1.
Communication as part of vaccine
pharmacovigilance
Vaccine pharmacovigilance has been defined as the science and activities relating to the detection,
assessment, understanding and communication of adverse events following immunization and other
vaccine- or immunization-related issues, and to the prevention of untoward effects of the vaccine
or immunization.83 Communication about potential risks, demonstrated safety and measures to
minimize risks, and programmes to support safe and effective use of vaccines, here referred to as
“vaccine safety communication,” are therefore a recognized part of pharmacovigilance. So far, for all
medicinal products, the implementation of established principles and guidance on communication
processes has been slow and incomplete worldwide.84, 85
Fundamental to achieving the aims of vaccine safety communication (see §2.1) is addressing
not only safety concerns identified by specialists, but also those concerns voiced by the general
public, (potential) vaccinees and their parents as well as healthcare professional (HCP). A strategic
approach to vaccine safety communication with collaborative links between all stakeholders has
been proposed for medicinal products in general86 and for vaccines in particular87 (see Chapter 4).
This can be integrated with the processes for monitoring and assessing the benefit-risk balances of
vaccines, so that concerns and information needs voiced by the public are included in benefit-risk
monitoring and assessments.
Data to be communicated are not only those about safety itself but also those contextualizing a risk
or an AEFI case(s), e.g. with data on disease epidemiology, vaccine use/exposure rates, baseline
rates of events which can occur with and without vaccination and baseline pregnancy outcome
data. A pharmacovigilance system therefore needs to collect such data not only for appropriate risk
assessment, but also for communication. These data should be collected routinely and proactively,
in order to allow for quick and valid assessments (see Example 2.3).
For effective communication and trust-building, it is likewise fundamental to be transparent in relation to
the public about the pharmacovigilance processes in place, the available data, remaining uncertainties
83 Council for International Organizations of Medical Sciences (CIOMS). Definition and application of terms of vaccine pharmacovigilance
(report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance). Geneva: CIOMS, 2012. Accessible at: https://cioms.ch/
shop/product/definitions-and-applications-of-terms-for-vaccine-pharmacovigilance/
84 Bahri P, Harrison-Woolrych M. Focussing on risk communication about medicines [editorial]. Drug Saf. 2012, 35: 971-975.
85 Bahri P, Dodoo AN, Edwards BD, Edwards IR, Fermont I, Hagemann U, Hartigan-Go K, Hugman B, Mol PG (on behalf of the ISoP
CommSIG). The ISoP CommSIG for improving medicinal product risk communication: a new special interest group of the International
Society of Pharmacovigilance. Drug Saf. 2015, 38: 621-627.
86 Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf. 2010,
33: 1065-1079.
87 Larson H. The globalization of risk and risk perception: why we need a new model of risk communication for vaccines. Drug Saf.
2012, 35: 1053-1059.
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and the rationale for decisions taken. It must be demonstrated that the pharmacovigilance processes
and data are robust and conducted in an unbiased manner (see Example 4.3.2 concerning the HPV
vaccine media monitoring at EMA).
Vaccine safety communication is a task that is continuously necessary during the entire life-cycle of
a vaccine product, beginning at the time of vaccine development, especially crucial at the time of
licensure/launch and to be maintained long-term throughout the post-licensure phase. As the safety
data base for a vaccine will increase over time, but also new safety concerns may be identified,
the messages to be communicated will evolve throughout the life-cycle. Pharmacovigilance nowadays
is increasingly proactive in collecting safety data and risk minimization through applying a risk
management approach, for which planning should start already before a vaccine gets licensed for
use (see §3.2).
3.2. Pre-licensure and launch phase
Two distinct processes occur when a new vaccine first becomes publicly available. One is the licensure88
by relevant regulatory authorities to ensure that a product is of ensured quality, safety and efficacy
and to specify the conditions for its safe and effective launch and usage in this jurisdiction in public
and private healthcare. The second is the launch of the vaccine by immunization programs in wide
or focused target populations in order to achieve specified diseases control and health objectives.
Sometimes, in countries of limited regulatory resources and/or other regulatory priorities, vaccines
will be launched in immunization programs relying on prior licensure in well-established jurisdictions,
without separate local licensure.89
Public awareness about a vaccine product may already begin prior to licensure and launch in early
clinical development of a vaccine, particularly if it is being developed in response to an unmet
health need or a current public health emergency. Examples are the malaria vaccine and the Ebola
vaccines. The development of the latter has been catalysed by the West African Ebola epidemic of
2014/2015, and overall results from both phase 1 and 2 studies were communicated by various
media outlets, although no single vaccine had yet been authorized (see Example 3.2.1).
Example 3.2.1: The need for understanding concerns in different communities
over the Ebola virus and vaccines prior to launching clinical trials
In response to the Ebola virus outbreak in West Africa in 2014, several candidate vaccines
that had demonstrated efficacy in animal models and could be produced at clinical grade,
were evaluated through a series of clinical trials. From the third quarter of 2014, phase 1 trials
were conducted concurrently in North America and Europe as well as in some African countries
that were not affected by the outbreak. By the first quarter of 2015, three phase 3 trials were
88 The terms “approval”, “authorization” and “licensure” in the context of vaccine (and drug) regulation in different jurisdictions mean the
declaration by a regulatory authority that a product following review was found to have a positive benefit-risk profile and is approved
for marketing and use. For consistency we have adopted “licensure” to cover any of these regulatory procedures or declarations.
“Marketing” (or “post-marketing”, etc.) is usually used to describe the phase of vaccine distribution following the manufacturer’s
decision to market the vaccine. The manufacturer may decide not to market a product even though licensure has been granted
by the regulatory authority. While “marketing” differs in meaning, we have adopted, for consistency, the terms “pre-licensure” and
“post-licensure” throughout this report to include everything that follows licensing of the product (i.e. “post-licensure” includes post-
marketing considerations that would apply in the specific context in which the term is used) (see Council for International Organizations
of Medical Sciences (CIOMS). Definition and application of terms of vaccine pharmacovigilance (report of CIOMS/WHO Working Group
on Vaccine Pharmacovigilance). Geneva: CIOMS, 2012. Accessible at: https://cioms.ch/shop/product/definitions-and-applications-
of-terms-for-vaccine-pharmacovigilance/.
89 Council for International Organizations of Medical Sciences (CIOMS). CIOMS Guide to Active Vaccine Safety Surveillance (report of
the CIOMS Working Group on Vaccine Safety). Geneva: CIOMS, 2017, Appendix I: Essential Vaccine Information, pp.57-59.
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initiated in the three most affected countries (Liberia, Sierra Leone and Guinea). Despite the
unprecedented pace in a vaccine clinical development process, these trials complied with
good clinical practices that are today expected in clinical research.
Planning and implementing those vaccine efficacy trials involved several communication
challenges related to what was known about the vaccines, the selection of vaccine recipients and
controls, and respecting an informed consent of participants with limited literacy. The general
acceptability of the intervention was also subject to concern initially, as outbreak control
measures had been complicated by traditional rituals, perception of disease transmission
and mistrust on the part of several communities.
In each country, investigation teams, including communication professionals, worked closely
with political and religious leaders to identify perception issues related to prevention of Ebola
virus disease and use of an experimental vaccine, serving as advocates for the population.
Local workers and communities were engaged to present the study purposes. Where the
protocol included vaccination of frontline workers, national and local public figures were
vaccinated early in some trials to ease population concerns and to indicate that supporting
the evaluation of vaccines against Ebola virus was a collective responsibility90.
At the time of licensure, knowledge about the safety of a vaccine is still limited. Most vaccine trials
are designed with a primary objective for efficacy, and their typical size of a couple of thousands
subjects limits the detection of adverse events to those that occur at a frequency > 1/1000.91 As
a result, most of the safety information included in the product label is limited to those events that
occur in 1/10 – 1/100 patients, and largely these events describe the expected local injection site
reactions and systemic events of fever and malaise.
In contrast, post-licensure use of vaccines is widespread with exposure in up to millions of subjects.
Therefore, even adverse events occurring more rarely, between 1/1,000 – 1/10,000, and thus not
observed in clinical trials, may affect thousands of individuals. Furthermore, most pre-licensure
clinical trials exclude certain populations, such as premature infants, pregnant women, or people
with underlying medical conditions. However, after launch vaccines are usually given universally
and may be, depending on the vaccine type and disease to prevent, encouraged in precisely those
populations excluded from clinical trials, e.g. pregnant women or older patients with multiple diseases.
Therefore it is crucial, prior to licensure, to adequately explore and document the gaps in the
safety database and plan how to fill these as quickly as possible in the post-licensure phase. Also it
needs to be planned how to minimize and prevent harm from identified or potential risks. A risk
management approach supports documenting how data are collected and risk minimization measures
are implemented and to decide, in the light of the results, if and how vaccine safety needs to be
further improved. While requirements for risk management systems may be tailored to the specific
needs and environment of a country, the concept is universal (see Guidance Summary 3.2.1). There
a number of risk minimization measures available for medicines (see Guidance Summary 3.2.2),
and they mostly require communication for their implementation.
90 Example provided by Dr. Andrea Vicari, Advisor Epidemic-Prone Diseases, Pan American Health Organization (formerly at WHO HQ),
per communication with Dr. Patrick Zuber, 28/08/2017.
91 European Medicines Agency (EMA). CHMP note for guidance on the clinical evaluation of vaccines. London: EMA, 2005.
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Guidance Summary 3.2.1: Concept of risk management systems for medicinal
products
A major conceptual example for risk management systems comes from the European Union
(EU). An EU risk management system was defined for the pharmaceutical sector first in 2005
and later in legislation as a set of pharmacovigilance activities and interventions designed to
identify, characterize, prevent or minimize risks relating to a medicinal product, including the
assessment of the effectiveness of those interventions92 (see Figure 3.2).
The submission of risk management plans describing product-specific risk management systems
have become a regulatory requirement for applicants/ marketing authorization holders in the EU,
commonly known as EU-RMP. These have to be submitted, using a defined template, with the
licensure application for every new medicinal product (including new generics) or for existing
products with a major safety concern. An EU-RMP describes what is known and not known
about the safety profile of the concerned medicinal product, indicates how so-called missing
information will be filled and the safety profile of the product further characterized through future
data collection, and demands measures to be taken for prevention or minimizing identified or
potential risks (see Guidance Summary 3.2.2). Summaries of the risk management plans for
the public are made available on the European Medicine Agency’s website.93
Figure 3.2: Risk management cycle
Improve safe use of
product throught additional
data collection and risk
minmisation measures as
necessary
Describe identifed and
potential risks and missing
information of the product
Collect data for further risk
identification and
characterisation and
overall assessment
Take measures to
prevent and
minimise identified
and potential risks
and possibly
precautionary
measures related to
missing information
Evaluate effectiveness of
risk minimisation measures
Source: European Medicines Agency, 2012.94
92 Directive 2001/83/EC of the European Parliament and of the Council, Article 1(28b).
93 European Medicines Agency and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices – Module V Revision
2: Risk management systems. Accessible at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/
document_listing_000345.jsp&mid=WC0b01ac058058f32c.
94 European Medicines Agency (EMA) and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices – Module V:
Risk management systems. EMA/838713/2011. London: EMA, 2012. 20 February 2012, p.7. Accessible at: http://www.ema.
europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123208.pdf.
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Guidance Summary 3.2.2: Types of risk minimization measures for medicinal
products
Product information:
f
f Package leaflet
f
f Product information for healthcare professionals (e.g. in the EU this is the summary of
product characteristics (SmPC))95
f
f Labelling on the outer packaging
f
f Pack size and design
f
f Educational materials
f
f Direct healthcare professional communications (DHPC)96
f
f Legal status of the product, e.g. prescription-only
f
f Controlled access programs
The application of risk minimization measures to vaccines can be more challenging. For example
the leaflet for the patient is rarely handed over to the vaccinee or the carer as part of the package,
because, unlike for other medicinal products, vaccines are often not provided to individuals in the
pharmacy but administered immediately in the clinic or another vaccination site. An example is provided
of a risk management plan for a vaccine assessed in the European Union (EU) in collaboration with
WHO in Example 3.2.2. Consideration has to be given as to how to communicate the safety advice
in the package leaflet amongst carers, to ensure that any possible risks are avoided and that carers
know how to limit the impact of an adverse reaction should it occur. This may be an objective of a
Vaccine Safety Communication Plan (see Chapter 4).
Example 3.2.2: Risk management planning for DTPw-HBV quadrivalent vaccine
A quadrivalent combined bacterial and viral vaccine protecting against diphtheria, tetanus,
pertussis and hepatitis B, and was assessed by the European Medicines Agency (EMA) in
collaboration with WHO, in order to facilitate its use in countries outside the European Union
(EU). Based on the clinical trials, the following was classified as ‘important identified risks’:
allergic reactions, high fever, convulsions, hypotonic-hyporesponsive episodes; and the following
as ‘important potential risks’: apnoea in prematurely born children, fainting, brain disorder.
In addition, the lack of safety and immunogenicity in children born prematurely was classified
as ‘missing information’. Given these safety specifications, no risk minimization measures other
than the product information were considered necessary.97 Information on the identified and
potential risks, including warnings and precautions for use to minimize their occurrence and
95 European Medicines Agency (EMA) and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices – Module XVI,
Rev 2: Risk minimisation measures: selection of tools and effectiveness indicators. London: EMA, 2017. Accessible at: http://www.
ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac058058f32c.
96 DHPC is considered an additional risk minimization measure beyond routine measures. For more information, see CIOMS IX Report
on Risk Minimisation for Medicinal Products, Geneva, Switzerland, 2014.
97 European Medicines Agency (EMA). Summary of the risk management plan (RMP) for Tritanrix HB [Diphtheria, tetanus, pertussis
(whole cell) and hepatitis B (rDNA) vaccine (adsorbed)]. London: EMA, 2014. Accessible at: http://www.ema.europa.eu/docs/en_GB/
document_library/Medicine_for_use_outside_EU/2014/03/WC500163201.pdf.
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severity of impact, has been included in the package leaflets for carers and the healthcare
professional information.98, 99
The next example (Example 3.2.3) demonstrates a successful launch of a new vaccine in India in
a climate of controversy in the public domain. While the example is taken from an immunization
program rather than communication by a regulatory authority, the approach taken to work with
stakeholders is equally applicable to pharmacovigilance.
Example 3.2.3: The introduction of pentavalent vaccines in Kerala, India,
supported by close interactions with the healthcare community and the media
Pentavalent vaccines, protecting against five potentially deadly diseases, namely diphtheria, tetanus,
pertussis, hepatitis B and Haemophilus influenzae type b (Hib), have been introduced successfully
in India. Some federal states became even early adopters with the help of communication efforts,
despite controversies prior to launch. Some individuals, active in alternative medicine but also
other healthcare professionals, questioned the utility and safety of the vaccines, and mainstream
daily newspapers joined in, opposing the introduction of the vaccines in the State of Kerala.
In response, a committee of local paediatricians and community doctors was constituted,
to examine in detail the issues raised and to prepare a full assessment of the benefit-risk
balance of pentavalent vaccines, taking into account the burden of infectious diseases and all
available published and unpublished data on the vaccines. The committee concluded that the
benefit-risk balance was positive, and a comprehensive communication strategy was applied.
This strategy started with a workshop, convened by the State and with support of UNICEF,
on 17 November 2011, with the officers from State departments, the heads of the paediatric
and community medicine of all medical colleagues and further concerned officials, to present
the report. Immunization guidelines, comprehensively addressing not only information on the
vaccine products themselves, but also on safe injection technique, cold chain requirements and
surveillance of potential adverse events, were disseminated in English and the local language.
Immunization cards with the correct dosing were disseminated as well.
This was accompanied by actual assessment of the equipment, a wide-reaching training
programme and a supervision plan for the daily monitoring of the immunization programme.
Further advocacy workshops were organized and a number of mass communication materials
in print and electronically were disseminated: posters, booklets and displays in major daily
newspapers. In areas of known vaccine hesitancy, closer interactions with these communities
were sought at various levels, including with those active in media folk arts and healthcare.
As regards interacting with the media, a specific press-conference was held to present the
committee report, and the fact that this was called by the Minister of Health demonstrated
highest leadership and commitment to safe immunization. This was followed up by media
sensitization activities prior to launch of the immunization programme, and these helped to
reduce undue criticism over vaccine safety in the media. Even when later, one baby sadly died
post-vaccination (note: death proved to be unrelated), the media reported on the examinations
done and the fact that all other children who had been vaccinated from the same vial were
healthy, and continued engaging in immunization advocacy.
98 European Medicines Agency (EMA). Trintanrix HB: product information. London: EMA, 2014. Accessible at: http://www.ema.europa.
eu/docs/en_GB/document_library/Medicine_for_use_outside_EU/2014/03/WC500163198.pdf.
99 Example provided by Priya Bahri, European Medicines Agency, London, United Kingdom.
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However, a communication strategy is never completed. As pharmacovigilance is a continuous
activity in the post-authorization phase of vaccines as of all other medicines, so is communication
with the public.
The events in the media in India after the successful launch of the immunization programme
in Kerala in 2012 illustrate this. Routine media monitoring revealed the following: of the 383
news stories on the pentavalent vaccine in all India from January 2013 onward, 57% coverage
was positive, while 21.5% coverage negative. In the course of 2013 however an increased
tendency of the media to hold the vaccine responsible for deaths and to portray the vaccine
sensationally was observed. Overall in 2013, 40% of the media coverage was negative.
A consistent lack of correct reporting on the vaccine and a need of re-sensitizing the media
about the importance of immunization was identified. As a result, UNICEF along with its partners,
held a series of media sensitization workshops and roundtable discussions in major cities
across India, i.e. in New Delhi, Chandigarh, Lucknow, Chennai, Raipur, Patna, Bhopal, Jaipur,
Kolkata and Guwahati. A number of senior editors from the print, electronic and broadcast
media operating in Hindi or English were engaged. Guidance for spokespersons about how
to interact with the media during an investigation of an adverse event following immunization
was also provided at trainings for immunization officers. A number of field visits of senior
journalists were organized to various states and hard to reach area in Assam, Jharkhand, Uttar
Pradesh, Bihar, Odisha and Madhya Pradesh, among others.
An analysis of print media articles conducted after this engagement with the media on
routine immunization issues revealed that, compared to 2013, positive coverage on the
pentavalent vaccine increased in 2014 by 126% and the negative coverage on the vaccine
fell by 66%. This was also partly due to the parallel media engagement being undertaken
for “Mission Indradhanush,” the Indian government’s initiative launched in December 2014 to
ensure that all children under the age of two and pregnant women are fully immunised with all
available vaccines.100 There was an increase in balanced coverage and the tendency of the
media to hold pentavalent vaccine responsible for deaths also fell. While the vaccine was held
responsible for AEFIs in 58% of media-reported cases in 2013, the media pointed at pentavalent
vaccines as responsible in only 31% in 2014. The media analysis findings corroborate the
effectiveness of sensitizing the media.101
3.3. Post-licensure phase
While at the time of licensure there is enough evidence to conclude a positive risk-benefit balance,
uncertainty regarding some aspects of the risks remain (see §3.2). When a product is launched, there is
however often little communication to the public about the knowledge gaps. Communications typically
address the identified and sometimes potential risks, which were observed in clinical trials and have been
included in package labels, but communication regarding more theoretical potential risks and missing
information in the safety database is usually lacking. With a view to transparency, it has been established
that messages to the public should honestly acknowledge uncertainties and that it is better to do this
proactively, rather than waiting for a debate in the scientific media to spill over into the general media.
During the post-licensure phase, the knowledge gaps get filled as safety data are obtained from
both passive surveillance systems (i.e. spontaneous reporting) and active systems (i.e. active safety
100
Mission Indradhanush: Centre asks all private TV, radio channels to promote government’s immunisation programme The Financial
Express PTI | New Delhi | Published: July 30, 2017. http://www.financialexpress.com/india-news/mission-indradhanush-centre-asks-
all-private-tv-radio-channels-to-promote-governments-immunisation-programme/786539/.
101
Example provided by Sonia Sarkar, UNICEF India.
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surveillance and epidemiological post-authorization safety studies),102 including those required by
a risk management plan if applicable (see §3.2). Safety signals103 identified from spontaneous
reporting systems often require subsequent epidemiological studies to quantify or to further
characterize the risk. However, most AEFIs detected from spontaneous reporting are so rare (i.e.
1/10,000 – 1/100,000) that follow-up epidemiological studies lack feasibility and statistical power
or require significant cooperation for collecting data from multiple database sources. Nevertheless,
often these types of rare events garner the majority of public attention in the media. Transparency
and clear communication throughout the evaluation of post-licensure safety signals is essential for
the maintenance of public trust in the vaccine safety processes and provide for informed choice.
With increasing post-licensure experience, knowledge of the safety profile of the vaccine increases,
and uncertainty decreases. With an acceptable safety profile and a successful communication
strategy, many vaccines receive general public acceptance in the long run. However, safety signals
may continue to arise which can for example be attributable to quality issues in the manufacturing
process, the introduction of new vaccines used in combination with older vaccines, or the expansion
of a vaccine indication to new populations. Communication strategies must be adaptable to new
needs; simply repeating a previous, general message (i.e. “this vaccine is safe”) is not adequate to
ensure continued public trust.
Examples for how communication has been handled successfully in relation to vaccine safety
concerns arising in the post-licensure phase are provided below (see Examples 3.3.1 and 3.3.2).
Example 3.3.1: Addressing the risk of febrile seizures with a serogroup
B meningococcal vaccines in the United Kingdom
A vaccine against meningococcal serotype B was licensed by the European Medicines
Agency (EMA) in 2013. Within the clinical trial program an increased rate of high fevers and
febrile seizures in those infants who received this vaccine in combination with routine infant
immunizations was noted. These risks were included in the package leaflet with a frequency
of > 1/100 and < 1/1000. Additionally, risk minimization measures to prevent fever and
subsequent seizures were described in the package leaflet as follows: “Your doctor or nurse
may ask you to give your child medicines that lower fever at the time and after [the vaccine]
has been given. This will help to reduce some of the side effects of [the vaccine].”
The UK was the primary country within the European Union which incorporated the meningococcal
B vaccine into its routine childhood vaccination program, and in September 2015 infants
started receiving the vaccination at 2 and 4 months of age in combination with pentavalent,
pneumococcal, and rotavirus vaccines. Active measures were taken by Public Health England
to inform both healthcare professionals and parents about the need for use of prophylactic
paracetamol at the time of vaccination. Healthcare professionals were provided both a protocol
document as well as access to an instructional video that simulated a conversation between
provider and parents. Parents were provided an information sheet at the time of discharge
after delivery of a new baby as well as a patient information leaflet offering advice on the use
of paracetamol.
102
Council for International Organizations of Medical Sciences (CIOMS). CIOMS Guide to Active Vaccine Safety Surveillance (report of
the CIOMS Working Group on Vaccine Safety). Geneva: CIOMS, 2017.
103
A signal is defined as information that arises from one or multiple sources (including observations and experiments), which suggests
a new potentially causal association or a new aspect of a known association between an intervention and an event or set of related
events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action (see Council for International
Organizations of Medical Sciences (CIOMS). Practical aspects of signal detection in pharmacovigilance. Geneva: CIOMS, 2010.). In
the context of safety, a signal refers to an adverse event.
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Below is the information leaflet which is distributed to parents at the time of vaccination with
the meningococcal B vaccine.104, 105
104
Public Health England. MenB vaccine and paracetamol. Accessible at: https://www.gov.uk/government/publications/menb-vaccine-
and-paracetamol.
105
Example provided by Rebecca Chandler, Uppsala Monitoring Centre (UMC), Sweden, with confirmation by email 14 August 2017 to
Karin Holm.
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Example 3.3.2: Addressing the safety concern of narcolepsy for the H1N1
pandemic influenza vaccine used in Sweden
A number of cases of narcolepsy in children were observed during the early post-licensure
phase of an H1N1 pandemic influenza vaccine used in late 2009. These cases were detected by
passive surveillance systems in both Finland and Sweden, countries in which mass immunization
practices had resulted in high vaccine uptake. Data for further characterisation and risk estimates
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were made available by active surveillance in the form of register-based studies designed in
response to the initial signal, and the assessment outcome was communicated to the public.
A review of the lessons learned from the H1N1 pandemic influenza vaccine -narcolepsy
experience was organized by the Swedish regulatory authority at a special symposium on
narcolepsy research related to this vaccine in November 2014, which brought together multiple
parties, including communication experts from the authority as well as representatives from
the narcolepsy patient advocacy group.
Questions were asked of these representatives regarding the expected content, timing, process
and channels for communication. In addition, they were asked about their impressions of the
availability of experts at the authority to answer questions as well as how to best improve
distribution of information to all parties in the future. Overall, the representatives felt that
communication was of good quality but they would have liked clearer messages on the causal
relationship rather than language including terms such as relative and absolute risks. There was
also confusion regarding the roles of experts from different public bodies, like the regulatory
authority and the public health authority. It was suggested that the regulatory authority should
have corrected obviously misleading statements from opinion leaders in the public domain and
the media through communication on its website as soon as possible.106, 107
106
Feltelius N, Persson I, Ahlqvist-Rastad J, et al. A coordinated cross-disciplinary research initiative to address an increased incidence
of narcolepsy following the 2009–2010 Pandemrix vaccination programme in Sweden. J Intern Med. 2015, 278: 335-353.
107
Example provided by Rebecca Chandler, Uppsala Monitoring Centre (UMC), Sweden, personal communication by email 8 March 2016.
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CHAPTER 4.
VACCINE SAFETY COMMUNICATION PLANS
(VACSCPS)
4.1.
Application of a strategic communication
approach to vaccine safety
Strategic thinking has increasingly been applied worldwide to health communication since the
1980s. The process of strategic health communication can be divided in five steps, the P-Process
of strategic health communication (Figure 4.1).
Figure 4.1: The P-Process of strategic health communication108
PARTICIPATION
1
Inquire
2
Design
Strategy
3
Create
& Test
4
Mobilize
& Monitor
5
Evaluate
& Evolve
CAPAC
I
T
Y
T
H
E
O
R
Y
™
P stands for planning. It is essentially characterized by agreeing clear communication objectives as well
as a communication plan designed to achieve these objectives, ideally in terms of desired behaviour.109 A
108
The Health Communication Capacity Collaborative. The P-Process: five steps to strategic communication. Baltimore, MD: Johns
Hopkins Bloomberg School of Public Health Center for Communication Programs, 2013. Accessible at: http://www.thehealthcompass.
org/sbcc-tools/p-process or http://ccp.jhu.edu/documents/P_Process_5_Steps.pdf.
109
The Health Communication Capacity Collaborative. The P-Process: five steps to strategic communication. Baltimore: Johns Hopkins
Bloomberg School of Public Health Center for Communication Programs, 2013. Accessible at: http://www.thehealthcompass.org/
sbcc-tools/p-process.
Step 1: Inquiry
f
f Analysis of the situation
f
f Management considerations
Step 2: Design strategy
f
f Agreement on communication
objectives
f
f Communication plan
Step 3: Create & Test
f
f Communication materials
Step 4: Mobilize & Monitor
f
f Implementation of plan
f
f Dissemination of
communication materials
Step 5: Evaluate & Evolve
f
f Evaluation if and how
objectives have been
achieved
f
f Evaluation of impact
f
f Updated communication plan
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call has been made to apply this approach to communication about safety of medicines in the regulatory
environment,110, 111, 112 as well as to public information for immunization programmes.113 This strategic
communication approach can also be used to create vaccine safety communication plans (VacSCP).
However, communication strategies are not generic ‘one-size-fits-all’, but require tailored messages
and appropriate tools and channels to reach specific segments of the population, including hard-to-
reach populations.114 Research on vaccine hesitancy has also shown that sentiments are vaccine-type
specific,115 and political and social situations can change, as can the overall public health situation.
For example, the situation where a continuation of successful vaccination is required for disease
prevention, such as in the case of measles, differs from the situation of a public health emergency
during a pandemic peak of a disease, and so the communication strategies will differ.
Different types of safety concerns will also require different responses, based on the evidence,
which may call for precaution, risk minimization measures or disseminating reassuring information.
Communication strategies for vaccines are more likely to succeed if they are integrated at local level
with the provision of other community health needs.116 Therefore the VacSCPs are to be designed
specific to a vaccine-type and a given local situation at a specific point in time.
It might not be feasible for an organization to immediately develop and maintain VacSCPs for each
vaccine, and a practical way is to create a generic plan suitable for the organization as a basis for
generating vaccine-specific plans according to the given situation and priorities, e.g. according to current
public health needs and the public debate. Key considerations for managers are listed in Checklist 4.1.
Checklist 4.1: Management considerations for VacSCPs
5
5 Understand the situation and identify public health priorities
5
5 Identify stakeholders including their roles and responsibilities
5
5 Allocate budget
5
5 Agree timeline for the implementation of the VacSCP
5
5 Monitor the implementation of the VacSCP 117
110
Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf. 2010,
33: 1065-1079.
111
Fischhoff B, Brewer NT, Downs JS. Communicating risks and benefits: an evidence-based user’s guide. Silver Spring, MD: US Food
and Drug Administration, 2009.
112
Minister of Health Canada. Strategic risk communications framework for Health Canada and the Public Health Agency of Canada.
Ottawa: Minister of Health Canada, 2007. Accessible at: https://www.canada.ca/en/health-canada/corporate/about-health-canada/
activities-responsibilities/risk-communications.html.
113
Waisbord S, Larson H. Why Invest in communication for immunization: evidence and lessons learned. Baltimore, New York: Health
Communication Partnership based at Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs
and the United Nations Children’s Fund (UNICEF), 2005. Accessible at: http://www.who.int/immunization/hpv/communicate/
why_invest_in_communication_for_immunization_unicef_healthcommunicationspartnership_path_usaid.pdf.
114
Waisbord S, Larson H. Why invest in communication for immunization: evidence and lessons learned. Baltimore, New York: Health
Communication Partnership based at Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs
and the United Nations Children’s Fund (UNICEF), 2005. Accessible at: http://www.who.int/immunization/hpv/communicate/
why_invest_in_communication_for_immunization_unicef_healthcommunicationspartnership_path_usaid.pdf.
115
Karafillakis E, Larson H, on behalf of the ADVANCE consortium. A systematic literature review of perceived risks of vaccines in
European populations. Vaccine. 2017; 35: 4840-4850..
116
Waisbord S, Larson H., 2005.
117
Based on: O’Sullivan GA, Yonkler JA, Morgan W, Merritt AP. A field guide to designing a health communication strategy. Baltimore,
MD: Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs: March 2003. Accessible at: http://
ccp.jhu.edu/documents/A%20Field%20Guide%20to%20Designing%20Health%20Comm%20Strategy.pdf.
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At the core of each VacSCP are its specific objectives in line with the overall aims of vaccine safety
communication (see §2.2). According to the theory of the strategic approach to health communication,
all concerned stakeholders should ideally work together and agree on the communication objectives,
plan and materials. However, for a regulatory authority there is often little time to publish new data
and the news cannot be shared preferentially with some groups prior to the general public. Yet to
some extent multistakeholder collaboration is practiced; for a number of years in some jurisdictions
regulatory authorities and the manufacturer have been agreeing on communication plans for
interventions like direct healthcare professional communications (DHPCs) which have facilitated
clarity and planning.118, 119 There should also be agreement between regulatory authorities and
the national immunization programmes, but it has to be understood that while the communication
messages about the benefit-risk profile and safety of a vaccine should indeed be consistent,
the communication plans will differ between these organizations, in order to align their objectives
with the distinct mandates of each organization (i.e. marketing authorization of vaccine products and
information about the benefit-risk balance versus issuance of vaccination schedules and promotion
of vaccination for public health protection).
4.2.
Developing VacSCPs on the basis of a model
template
VacSCPs may be developed by the professionals of the vaccine safety communication system of
the regulatory body (see §5.1) through a multistakeholder interaction (see §4.1 and §5.2), using
the model template provided in Template 4.2.120 This VacSCP model template is based on the
communication plan template for vaccine safety events issued by WHO121 and has been enhanced
in line with the P-Process (see §4.1) and its application to pharmacovigilance.122
The effectiveness of a VacSCP will very much depend on the depth and width of the initial understanding
of the situation and the audiences (see §2.1), and on the cooperation with stakeholders from the
VacSCP development phase and the whole communication cycle (see §4.1). Guidance for understanding
and monitoring the situation (which both use the same methods) is provided in §4.3.
118
Following informal use for a number of years, the following template has been published as part of EU-GVP: European Medicines
Agency (EMA) and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP) – Annex II – Templates:
Communication Plan for Direct Healthcare Professional Communication (CP DHPC). London: EMA, 8 December 2015, Rev 1 12 October
2017. Accessible at:http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.
jsp&mid=WC0b01ac058058f32c.
119
Health Canada. Issued Health Professional Communication – Dear Health Care Professional Letter document 3, 2008. http://www.
hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2008-risk-risques_comm_guid-dir/index-eng.php#Document3.
120 The CIOMS VacSCP template is available in a downloadable form on the CIOMS website: www.cioms.ch.
121
World Health Organization Regional Office for Europe. Vaccine safety events: managing the communications response. Copenhagen:
WHO, 2013.
122
Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies.Drug Saf. 2010,
33: 1065-1079.
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Template 4.2: Template for strategic vaccine type- and situation-specific vaccine
safety communication plans (VacSCPs)
CIOMS Vaccine Safety Communication Plan (VacSCP)
Vaccine product(s):
I. Situation and monitoring
Vaccine safety:
Epidemiology:
Public:
Monitoring of public KAP, concerns, rumours and information needs:
II. Communication objectives

III. Strategic design of the communication intervention
Target audiences:
Change model:
Key messages:
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Communication tools and dissemination mechanisms in a mixed media approach:

Interactions with journalists and community advocates/activists:
Timetable:
Transparency provisions:
IV. Monitoring and evaluation

A step-by-step guide to developing communication strategies for vaccine benefit-risk communication
with practical examples has recently been developed in Europe and can also be helpful to follow
when developing VacSCPs (see Guidance Summary 4.2).123
Guidance Summary 4.2: Developing communication strategies on vaccine benefits
and risks
Communication strategies for vaccine benefit-risk information aims at maintaining and improve
public confidence in vaccination by demonstrating that decisions about vaccination are based
on robust data and integrity. It is therefore important to communicate about the partners
generating and using data and their framework of collaboration, including their code of conduct
and quality management processes.124
The development of such communication strategies should follow a practical stepwise approach:
f
f Step 1: define goals and objectives of the communication strategy;
f
f Step 2: map and engage with the various stakeholders;
123
Accelerated Development of Vaccine beNefit-risk Collaboration in Europe (ADVANCE). Developing Communication Strategies on
Vaccine Benefits and Risks. ADVANCE, 2017. Available at: http://www.advance-vaccines.eu/?page=publications&id=DELIVERABLES.
124
Accelerated Development of Vaccine beNefit-risk Collaboration in Europe (ADVANCE). Developing Communication Strategies on
Vaccine Benefits and Risks. ADVANCE, 2017. Available at: http://www.advance-vaccines.eu/?page=publications&id=DELIVERABLES.
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f
f Step 3: develop the communication content and core components of the strategy (e.g.
selected audiences, preferred channels) (step 3);
f
f Step 4: plan implementation and monitoring. (step 4).
4.3. Monitoring, evaluating and maintaining VacSCPs
The VacSCP is a ‘living document’ to be updated to meet changing situations: New risks or safety
information may emerge at any time during the life-cycle of a vaccine (see Chapter 3), the epidemiology
of the disease to vaccinate against may change over time as well as the public KAP, concerns and
information needs. Among other things, the public debate overall may increase, decrease or change
in focus or stakeholders involved.
Therefore regular monitoring and evaluation activities are necessary to maintain the VacSCP and
adapt it at any time before, during and after a communication intervention. When deciding on revising
or designing future communication interventions and their timings, stakeholders need to take into
account the risk of either over-communication and related the amplification of risk perception (see
§2.2) or alert fatigue and associated decrease in risk perception and adherence to safe use advice.125
Real-time monitoring and regular evaluation, and subsequent adjustments are also essential for
preventing and managing crisis situations.
In addition VacSCPs need to be updated with the learnings from the evaluation of the communication
intervention as part of the cyclic communication process (see §4.1). The evaluation is a ‘lessons
learnt’ exercise, describing the effectiveness of the communication intervention in relation to the
set objectives, or unintended effects, whether positive or negative. More specifically, the purpose of
evaluation is to identify further communication needs for maintaining or improving success, and to
adjust the VacSCP and communication interventions, building on the experience and evidence
generated by the evaluation.
Evaluating communication interventions and thereby the vaccine communication system (see Chapter 5)
forms part of quality management of the system and is necessary for fulfilling accountability through
evidence. This should contribute to justifying resources for vaccine safety communication systems.
Evaluating is not an easy task, but it is essential for the sustainability of the systems and their
outcomes. However, rather than looking at evaluation from a sequential process perspective only,
a broader view incorporates a continuous real-time monitoring of the implementation and impact of
communication interventions in addition to evaluations after an intervention.
The methods and results of monitoring and evaluating of implementation, its effectiveness and other
impact should be transparent and explained in their meaning and limitations. The main challenge
lies in finding methods and meaningful indicators, which ideally can, beyond describing change,
also study causal relationships with the communication interventions and the factors which may
influence impact. For this, data pre- and post-intervention as well as on influences other than the
intervention should be collected. In any case one should ensure that mechanisms are in place for
simple monitoring and feedback from all audiences. These may include measuring the dissemination
of messages through various media, KAP surveys, media monitoring and calculating vaccination
rates. The acronym KAP provides a reminder to conduct surveys comprehensively, to capture
knowledge, attitude and practice.126
125
Agency for Healthcare Quality and Research (AHQR), U.S. Department of Health and Human Services. Patient safety primer: alert
fatigue. Rockville, MD: AHQR, June 2017. Accessible at: https://psnet.ahrq.gov/primers/primer/28/alert-fatigue.
126
United Nations Children’s Fund Regional Office for South Asia (UNICEF-ROSA). Building trust and responding to adverse events
following immunisation in South Asia: using strategic communication. Kathmandu: UNICEF-ROSA, 2005.
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In relation to knowledge, it should be measured how far an audience’s awareness and understanding
of factual information has changed. Through attitude surveys, one can study the sentiments people
have formed about something or somebody, and how these change over time (e.g. from hostile to
neutral or accepting of a proposal like vaccination or safe use advice, or to becoming increasingly
adverse and non-trusting). Practice relates to the behaviour, such as actual vaccination.
4.3.1
Monitoring of debates and sentiments in communities and
the public
Monitoring of the public debates in the news and/or social media can happen daily using a defined
list of newspapers in paper or online news media outlets, social media search tools, or through
making use of a media intelligence service127 or academic research departments. The feasibility and
usefulness of media monitoring is illustrated with examples from the polio immunization program in
Israel (see Example 4.3.1) and from the European Medicines Agency (EMA) for a safety assessment
on HPV vaccines (see Example 4.3.2). A good example for monitoring Twitter for vaccine debates in
multiple languages can be found in the literature.128 One can also monitor media queries and questions
from the public to the organization. Regular exchange with community and opinion leaders can also
provide important insights, and supplement quantitative data (i.e. obtained through measurement)
with regard to possible causal relationships and factors influencing communication effectiveness.
Where measurements are difficult, the observations from community and opinion leaders able to
provide feedback in comprehensive, unbiased manner are even more valuable.
127
This may be a commercial service, but non-commercial tools are also available for own use, such as MEDISYS, provided by the
European Commission under: https://ec.europa.eu/jrc/en/scientific-tool/medical-information-system.
128
Becker BF, Larson HJ, Bonhoeffer J, van Mulligen EM, Sturkenboom MC. Evaluation of a multinational, multilingual vaccine debate
on Twitter. Vaccine. 2016; 34: 6166-6171.
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Example 4.3.1: Social media monitoring during polio supplementary immunization
activities (SIA) in Israel
In response to the reintroduction of wild poliovirus, the Israeli Ministry of Health, in 2013,
conducted a large-scale media campaign with successful media monitoring. In that year, a wild
poliovirus was detected in routine environmental surveillance in a sewage system in the Southern
part of Israel. The population immunity was high, with vaccination coverage with inactivated
polio vaccine (IPV) above 95% and without detection of actual polio-cases. Still, it was decided
to implement supplementary immunization activities (SIA) with oral and injected polio vaccines.
Initially, this decision caused resistance in some groups. However, through concerted effort
and a comprehensive communication strategy the campaign became a success. A key element
contributing to this success was a sophisticated system of media monitoring to understand
public opinion and respond to concerns. As part of this effort, health authorities via social media
became aware of a planned anti-vaccination protest demonstration and were able to mobilize
polio victims to address the public at this demonstration. An indication of the success of the
campaign is that at the beginning only 55% of parents said they would bring their children for
supplementary immunization, but a few months later, after the communication interventions,
75% of the targeted children had been vaccinated, i.e. more than 900,000 out of 1.2 million.129
Example 4.3.2: Utility of online news media monitoring for prepared
communicating of the outcome of a safety assessment for HPV vaccines at the
European Medicines Agency (EMA)
Public debate regularly centers around the benefit-risk of vaccines often taking place in
traditional and social media. To address this trend, the European Medicines Agency (EMA)
wanted to examine the utility of media monitoring and how it could be useful for regulatory
bodies. In 2015 EMA conducted a media monitoring study concerning human papillomavirus
(HPV) vaccines over the period of time during which a procedure was instigated to investigate
the potential causality of two suspected adverse reactions reported to the authorities: complex
regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS).
Prospective real-time monitoring of worldwide online news was undertaken from September to
December 2015 with inductive content analysis. More than 4000 news items – originals and
re-posted ones – were collected, containing personal stories, scientific and policy/process-
related topics. Explicit and implicit concerns voiced in the news media and some linked blogs
were identified, including those raised due to lack of knowledge or anticipated once more
information would be published, generating ‘derived questions’.
Rather than describing these concerns and information needs in factual style, those collected
until 24 October were ‘translated’ into scientific or regulatory language and formulated as
50 questions (which could be categorized into 12 themes). The questions related to a wide
range of topics, such as CRPS and POTS case definitions, underreporting of suspected
adverse reactions, trustworthiness of data as well as the standards and code of conducts of
regulatory bodies.
129
Kaliner E, Moran-Gilad J, Grotto I, et al. Silent reintroduction of wild-type poliovirus to Israel, 2013: risk communication challenges in
an argumentative atmosphere. Euro Surveill. 2014, 19: 20703.
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The ‘derived questions’ were provided to assessors and medical writers/media officers at
the EMA and the EU member states for use in real life and preparing the communication of
the outcome of the assessment on 5 November. It was demonstrated that providing media
monitoring findings to assessors and medical writers/media officers resulted in: (1) confirming
that public concerns regarding CRPS and POTS would be covered by the assessment; (2)
meeting specific information needs proactively in the public statement; (3) predicting all queries
from journalists received at the press conference on 5 November and in writing thereafter;
and (4) altering the tone of the public statement with respectful acknowledgement of the health
status of CRSP and POTS patients.
The study demonstrated the utility of media monitoring for regulatory bodies to support
communication proactivity and preparedness. Derived questions seem to be a suitable
method since regulators normally formulate situations as research questions. Presenting
media monitoring results in the scientific-regulatory environment and formulating the media
content as questions were both novel approaches that yielded useful information. The study
suggests that media monitoring could form part of regular surveillance for medicines of high
public interest.130
130
Bahri P, Fogd J, Morales D, Kurz X, ADVANCE consortium. Application of real-time global media monitoring and ‘derived questions’
for enhancing communication by regulatory bodies: the case of human papillomavirus vaccines. BMC Medicine. 2017 May 2, 15:91.
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CHAPTER 5.
VACCINE SAFETY COMMUNICATION
SYSTEMS
5.1.
Functions of vaccine safety communication
systems
Generally, systems are understood as consisting of structures and processes to fulfil certain
objectives; and in order to enable preparing and implementing planned communication, a vaccine
safety communication system consists of certain key functions (see Checklist 5.1). Depending on
the structure of the regulatory authority, all functions might form one dedicated department or
there might be a split between planning, implementing and evaluating communication interventions.
Taking into account local resources, opportunities and priorities, an organization may choose which
functions to build up first and to which extent, so that a tailored system can be built up over time.
Checklist 5.1: Key functions of vaccine safety communication systems
5
5 Development of strategic vaccine-type and situation-specific vaccine safety communication
plans (VacSCPs)
5
5 Establishment and maintenance of multistakeholder networks
5
5 Collaboration at local, country, regional and international level
5
5 Monitoring of vaccine knowledge, attitudes, practices (KAP) and related concerns, rumours
and information needs
5
5 Interaction with the media through a dedicated spokesperson
5
5 Development of communication messages and materials
5
5 Implementation of communication interventions
5
5 Evaluation of communication interventions
5
5 Management of vaccine safety crisis
5.2. Multistakeholder network
Vaccine safety communication consists of complex processes of listening and messaging between
those with responsibilities for vaccine safety as well as institutional and public stakeholders at local,
country, regional and international level (see Table 5.2.1).
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Table 5.2.1: Main stakeholders involved in the vaccine safety communication
process
f
f Regulatory authorities
f
f Public health authorities
f
f National immunization committees
f
f National advisory committees on adverse events following immunization
f
f Health technology assessment bodies
f
f Ministries of health
f
f Local and national politicians
f
f Vaccine manufacturers
f
f Representatives of vaccine target populations, vaccinees, parents, carers and the community
(villages, civil society), including e.g. women’s groups, anti-vaccine groups, citizen watchdogs
f
f Religious and community/public opinion leaders, including e.g. teachers
f
f Representatives from healthcare professionals in public and private healthcare, traditional and
alternative healer communities, healthcare professional associations, learned societies
f
f Media representatives and journalists
f
f Non-governmental organizations
f
f Donors and procurement agencies
f
f Technical development agencies
f
f Multilateral agencies, e.g. World Health Organization (WHO) and its Global Advisory Committee
on Vaccine Safety (GACVS), UNICEF
Any stakeholder group or individual may take particular roles in shaping public and personal sentiments
and impact on knowledge, attitude and behaviour of individuals. Opinion leaders may be healthcare,
community and religious leaders, teachers, journalists, or come from a trusted governmental or
non-governmental organization or interest groups like anti-vaccine groups, women’s groups or citizen
watchdog groups. An opinion leader can come from inside or outside a concerned community or
country. Opinion leaders may specifically act as intermediaries between the authorities and the public.
Communication in the public domain impacts on interpersonal communication between individuals in
healthcare settings as it occurs (e.g. when discussing informed consent, proposed vaccination of
children or suspected harm due to a vaccine). Individuals often trust their physician, nurse, midwife,
pharmacist and/or other traditional/alternative healthcare professionals or sources.
An essential function of a vaccine safety communication system therefore is the stakeholder and
community network, which needs to be established over time and be carefully maintained (see
Checklist 5.2) for a number of important objectives (see Table 5.2.2). Overall, collaboration with
the network should allow for multiple perspectives on vaccines and approaches to solve issues,
making use of communication for increasing common understanding, disseminating the evidence
base and achieving agreements. Understanding of the complexity of the network may be facilitated
by thinking about and mapping interactions according the social ecological model (SEM)(see §2.1).
Checklist 5.2: Establishing and maintaining national stakeholder networks
5
5 Set objectives of interactions
5
5 Build capacity and infrastructure for public dialogue and deliberation
5
5 Map majority and minority stakeholders, their roles and how to approach them, including
in case of vaccine or communication crisis
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5
5 Create a national media map
5
5 Define mechanisms and policies for interactions
5
5 Establish a code of conduct for governmental organizations and other policies to avoid
lobbying, conflict of interests and bias and keep transparency
5
5 Demand, as a governmental organization, transparency from all stakeholders of information
sources, finances and interests
5
5 Define a policy for what are appropriate collaborations from vaccine manufacturers
5
5 Create a public calendar of interactions, e.g. newsletters and events
5
5 Publish outcomes of interactions and express thanks for the contributions
5
5 Offer subscriptions and services to ask questions and provide feedback
Table 5.2.2: Purposes of multistakeholder interactions
f
f Listening to current understanding, concerns and information needs of the public regarding
vaccines in general and in relation to specific issues;
f
f Involvement of audiences in the development of VacSCPs and communication interventions,
including usability testing;
f
f Provision of collaboration, e.g. for defining and agreeing messages about vaccine risks/
safety, participation of community(ies) in consultations undertaken by regulatory authorities and
deliberation processes;
f
f Interactions with the media; and
f
f Demonstrating trustworthiness and trust-building.
The institutional stakeholders at local and country level include those in charge of vaccine licensure,
healthcare payments and reimbursement, procurement, supply management, immunization policy-
making and immunization program management. Also, stakeholders along the vaccine supply chains
may need to communicate at population level, as they have the responsibility for selecting high quality
safe vaccines and distributing them safely. Vaccine manufacturers are an institutional stakeholder
too, and may be from inside or outside the country. Each of the institutions will have their assigned
responsibility in the overall vaccine safety process within the country and consequently have a need
for their own vaccine safety communication systems. Communication between these institutional
parties may or may not happen in the public domain.
Mechanisms need to be in place for cooperation between these organizations, so that communication
messages about the safety of specific vaccines are consistent, despite that communication objectives
will differ between organizations in accordance with their legal mandate. For example, public health
agencies have to primarily communicate about the immunization programmes, while regulatory
authorities communicate about the benefit-risk profiles of individual vaccine products. Despite
close collaboration, regulatory authorities and other public bodies must keep their independence.
Likewise the legal responsibilities of all parties in vaccine safety have to be respected as well as
the independence of the media.
Public stakeholders include the vaccine target populations, their families, healthcare professionals,
the communities, interest groups and the media. The media are comprised of both traditional and
evolving print, paper, mail, poster, television, radio, electronic and web-based news and social media,
such as Facebook and Twitter. Interactions with the media should provide journalists, proactively
and in responsively, with accurate information about the safety profile and safe use of vaccines,
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without trying to influence them in a way that would, truly or be perceived as, trying to jeopardize
the independence and freedom of the media.
Good interaction with stakeholders can prevent a crisis situation, as shown in the following Example 5.2.
Example 5.2: Managing an adverse event following immunization with HPV vaccine
in the United Kingdom
In September 2008, the Department of Health (DH) of the United Kingdom (UK) launched their
national programme to vaccinate girls aged 12-13 against human papillomavirus (HPV). At the
same time, a two-year catch-up campaign began to vaccinate older girls under the age of 18
years. The programme has largely been delivered through secondary schools. Three doses
of HPV vaccine are given over a six-month period. The first year of the programme achieved
high vaccination coverage with all three doses (81% of the girls aged 12-13 years).131 More
than 1.4 million doses had been given since the vaccination programme started.
On 28 September 2009, a 14-year old girl died shortly after receiving an HPV vaccination
at her school in Coventry, UK. When a serious adverse event following immunization (AEFI)
occurs, it is important that accurate information is communicated in the media and that the
facts of the event do not become distorted. Through proper handling of the media response
to AEFIs, health officials can avoid loss of public confidence in vaccination. The following
table summarizes the events of 2008 and how the respective authorities responded as the
events unfolded:
Day 1 – September 28, 2009
Student dies 75 minutes
after HPV vaccination.
Known medical facts:
f
f 10:45 a 14-year old girl receives an HPV vaccination along
with other girls in her school.
f
f At about 11:30 she collapses at school.
f
f By noon she has died at the hospital.
f
f There was no evidence of an acute allergic reaction.
Responses
Local health department
(NHS Coventry)
1. Informed the UK DH immunization director.
2. Informed the national drug regulator (MHRA) of an adverse
event through the yellow card system.
3. Issued a brief press statement including facts of death,
sympathies to family and friends, and announcing that
an urgent and full investigation was being conducted.
Statement also warned that:
“No link can be made between the death and the vaccine until
all the facts are known and a post mortem takes place.”
131 United Kingdom Department of Health and Health Protection Agency. Annual HPV vaccine uptake in England
2008/09.
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National health department
(UK DH)
1. Quarantined vaccine batch as a precautionary measure
and alerted local Directors of Public Health, Immunisation
Coordinators and General Practitioners.
2. Confirmed that MHRA had received yellow card and began
investigation.
3. Issued press statement with facts of death and information
on the vaccination programme.
4. Decided not to suspend vaccination programme during the
investigation.
5. Decided not to assign a government spokesperson for
interview requests.
6. Decided not to make any further statements until new
information was available.
School misinforms parents Sent a letter to parents that said:
“An unfortunate incident occurred and one of the girls suffered
a rare, but extreme reaction to the vaccine.”
However, at this point the cause of death was unknown and
it was impossible to say whether this tragedy was caused by
a reaction to the vaccine. Even though the school corrected
this information on their website later that evening, it caused
confusion and concern among the parents and media.
High media interest Local and international evening broadcast news reports girl’s
death shortly after receiving HPV vaccination.
High interest from media in the story.
Day 2 – September 29
Responses
Political opposition
criticizes government
An opposition politician noted that the government had chosen
the vaccine product used and suggested that the competitor’s
vaccine could have been a safer option. He called for safety
data to be published.
Manufacturer recalls
vaccine batch
Manufacturer voluntarily recalled vaccine batch.
National (UK DH) waits for
new information
Decided not to respond to political opposition claims and
followed their policy against making additional statements until
new information was available.
There was concern it could be days before the autopsy results
were known. Internal intelligence allowed communications
offers to brief journalists with whom they had a relationship to
be cautious about any speculation that the vaccine caused the
death until more information was known.
Preliminary post-mortem
results
In the evening, preliminary autopsy results found that the girl’s
death was due to a rare serious underlying medical condition
and that the vaccination did not play a role in her death.
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UK DH contacts media At about 9:30 PM UK DH communication officers urgently
began contacting TV news teams, followed by the Press
Association, and newspapers in time for the 10 PM UK
television news programmes, and to reverse any negative
headlines in the next day’s papers.
High media interest Interest in story remains high.
Evening broadcast news (10 PM) reported preliminary post-
mortem results.
Day 3 – September 30
Responses
UK National Institute for
Biological Standards and
Control
Preliminary testing of vaccine batch found it to fully conform to
all safety standards.
National (UK DH) Informed school services to continue immunizing with HPV
vaccine.
Offered government spokespeople for interviews with the
media, but media was no longer interested.
Secondary story
emerges….
Legal firm alerted the press that it was representing the
families of 10 English girls who, they claim, had been
adversely affected by HPV vaccination. It is the basis for two
features, one in the Daily Mail, the other in Sunday Times.
Media Most morning newspapers did not reflect preliminary post-
mortem results.
Preliminary post-mortem results announced during the day.
Story begins to die out in the mainstream press.
Day 4 – October 1
Responses
Post-mortem results
published
Preliminary post-mortem results are published.
National (UK DH) reaches
out to media
Offered government spokespeople for interviews with the
media, but there is little interest from the media.
Media coverage drops Reports on published post-mortem results.
Story continues to die out in the mainstream press.
The death of the student shortly following HPV vaccination instigated widespread media attention,
sometimes with erroneous, misleading, confusing headlines, and provoked public concern
about the vaccine. Some media stories created a false assumption that there was a true risk
with the vaccine. Some stories created the impression that the vaccination programme was
in chaos, and by implication that the government had lost control of the situation.
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The most vivid example of inaccurate reporting was published in the weekly Sunday Express
on 4 October (“Jab as deadly as the cancer”), eight days after the student’s death and long
after the vaccine was cleared from playing a role in the death. Independent news media plays
a pivotal role shaping public perception of vaccination programmes. In this case, the media
was most interested in the story when there were unanswered questions about the safety of
the vaccine. These kinds of questions can give rise to rumours and false information. It is
therefore important for vaccine safety communicators to get in front of the story to frame the
questions in the media and provide accurate answers rather than be reactive because chasing
and countering rumours and misinformation is difficult and often not entirely successful.
The HPV vaccination programme in the UK was not at any point in time in jeopardy. In Coventry,
the local National Health Service (NHS) did not suspend its vaccination programme, but rescheduled
clinics for Tuesday and Wednesday to give staff the chance to be fully briefed to answer public
enquiries. In some areas vaccination sessions were temporarily halted because their vaccine
supply was from the batch that was quarantined.
This case never reached crisis level due to the immediate and appropriate management of
the situation by the UK DH.
The following contributed in particular to this effective management:
f
f Immediate coordination of communications with school officials;
f
f Issuing of a preliminary statement within a few hours;
f
f Close collaboration between government communication and immunization departments;
f
f Being careful about making public comments when not yet fully informed and confirming
available facts before making any public statements;
f
f Communication with receptive journalists with whom a relationship already exists;
f
f Keeping politics out of the story;
f
f Being sensitive (while the administration of a vaccine shortly before this girl died was a
coincidence, all correspondence needed to be sensitive to the fact that this was a local
tragedy).
Immediate management requires being prepared, especially regarding the following:
f
f Knowing the baseline incidence of possible serious adverse events;
f
f Training vaccination personnel at all levels to respond adequately;
f
f Prepare a plan to react to a crisis when it occurs, including immediate reporting of AEFIs
to the national agency responsible for pharmacovigilance.
With a view to understand the impact of the student’s death on the public perception of HPV
vaccines and thereby also evaluate the impact of the communication during the investigations,
the UK DH designed a survey that would allow them to compare current public perceptions
with those existing before the programme began. They could do so because the UK DH had
conducted surveys, beginning three years before the introduction of HPV vaccination, as follows:
f
f 2005. Initial qualitative research conducted among parents about their attitudes and
awareness of HPV and HPV vaccine.
f
f 2007. Just over a year before the launch of the programme, surveys were carried out
among students, parents and health professionals:
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f
f one survey measured the opinions of HPV vaccination among parents of 8- 9 years-old girls;
—
— this survey was repeated among 12-years-old girls and their parents;
—
— this information was intended to determine the most acceptable age to target vaccination,
as it was important programmatically because it shifted the implementation from
primary to secondary school environments;
—
— Some of these surveys provided “pre-campaign” or “baseline” data to be used to
monitor changes in attitudes and awareness of HPV vaccine.
f
f 2008. Once the vaccination programme was underway – the routine programme began
as well as the catch-up campaign – surveys were regularly carried out to track progress
and detect changes in the programme.
f
f 2009-10. Surveys were regularly carried out to track progress and detect changes in
the programme, while the routine programme continued and the catch-up campaign was
concluded.
Further in 2007 a survey measured public perception of the vaccine by asking mothers and
daughters to read an information card on HPV and the vaccination programme. They were then
asked how favourable they felt towards the vaccination. In that survey at least four out of five
respondents (80%) in each group said they were “very” or “fairly” favourable of the HPV vaccine.
After the death of the student, the UK HD conducted a new survey, again asking mothers and
daughters to read an information card on HPV and the vaccination programme and how favourable
they felt towards the vaccine. There were no significant changes in the high levels of favourability
toward the HPV vaccine after the student’s death. At least four out of five respondents (80%) in
each group said they were “very” or “fairly” favourable of the HPV vaccine.
The awareness that a student had died shortly after receiving HPV vaccination was assessed by
an additional survey. Mothers and daughters were asked what they had recently seen or heard
in the media about HPV. Between two and three in ten mentioned the event in their responses
(i.e. they demonstrated spontaneous awareness). If the student death was not mentioned at
this stage, respondents were asked directly if they were aware of the incident – this question
measured prompted awareness. Including prompted responses, over 80% of mothers and
70% of daughters were aware of the case. The remaining mothers and daughters were “not
aware” of the incident.
Those who had reported being aware of the death of the student were asked to describe how
concerned they had initially felt at the time the event occurred. At least seven in ten of respondents
were initially concerned about the vaccine. When mothers and daughters were asked how
concerned they currently felt, now that it was clear that the girl’s death was not linked to the HPV
vaccination, most mothers and daughters were no longer concerned about the HPV vaccine.
Today, the UK regularly monitors public opinion on vaccination and trust in health authorities
through both quantitative and qualitative research. This means that they are able to detect
changes in public trust or opinions on vaccination and respond to them, long before they
could develop into a crisis. 132
132
World Health Organization (WHO). Managing an adverse event following immunization: an interactive case study. Geneva: WHO,
2011. Accessible at: http://vaccine-safety-training.org/c-resources.html.
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5.3.
Regional and international awareness and
collaboration
Immunization is a matter of global public health and news and rumours may travel quickly. For these
reasons, a vaccine safety communication system needs to maintain awareness of the vaccine safety-
related discussions around the globe that may have an impact in one’s own country. On particular
issues, an adverse event reported in one country may have implications for other places using the
same product or batch of a particular vaccine. Optimal international communication on vaccine
safety issues can be enhanced when those national authorities in charge of the national immunization
program or assessment and licensure of vaccines, that are the main government entities responsible
for vaccine safety, are familiar with international parties and experts who can provide them with
information, independent advice or information to rely upon for key messages. In Figure 5.3 the
relationships between the main parties for global collaboration are presented. This schematic
highlights the need for the stakeholder network (see §5.2.) not only to cover the local or country
level, but also to enable regional and international collaboration.
Figure 5.3: Relationships of parties in global vaccine safety
National AEFI surveillance,
investigation and response*
Immunization
programme
AEFI review
committee
Pharmaco –
vigilance
experts
Regulatory
authority
Global and regional analysis and response
Product monitoring
Global signal
detection and
evaluation
Global capacity
building and
harmonized tools
Multilateral
organizations
Vaccine
manufacturers
Global Advisory Committee
on Vaccine Safety (GACVS)
Other global or regional
advisory bodies
Technical agencies
Donors
International
networks
Programme for
International Drug
Monitoring
Vaccine Safety Net
Licensing authorities
in countries of
manufacture
Procurement
agencies
* Several entities that participate in the national primary health care system usually contribute to vaccine pharmacovigilance.
Source: World Health Organization. Adapted for CIOMS Guide to Active Vaccine Safety Surveillance, 2017.133
133
World Health Organization. Adapted for CIOMS Guide to Active Vaccine Safety Surveillance (2017) from graphic WHO entitled,
“Components of a 21st Century global vaccine safety monitoring, investigation, and response system.” Module 5: Vaccine safety
institutions and mechanisms Vaccine safety basics learning manual, www.vaccine-safety-training.org.
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At international level, a number of stakeholders are specifically important for LMICs: The Global
Advisory Committee on Vaccine Safety (GACVS) provides independent, authoritative, scientific advice
to WHO on vaccine safety issues of global or regional concerns with the potential to affect in the
short or long term national immunization programmes. Its assessments of vaccine safety issues are
publicly available and statements are occasionally produced when urgent concerns are identified.134
WHO Strategic Advisory Group of Experts (SAGE) develops recommendations for vaccine utilization
based on a risk-benefit analysis informed by GACVS assessments. WHO, UNICEF and their country
offices and other partner technical agencies and donors are engaged in the Global Vaccine Safety
Initiative (GVSI). Donors are important parties as they interact with immunization policy decision-
makers, can prioritize resources, and provide access to non-state and private sector parties.
Particularly for supporting communication a country level, WHO has created the Vaccine Safety Net
(VSN) 135 as a network of more than forty reputable governmental, professional associations and
academic websites (with a combined reach estimated at millions of visits each year) that provide
vaccine safety information in various languages. Each website has been evaluated by WHO and after
having met criteria for good information practices was added to the VSN list of reliable websites.
The VSN aims to address the variable reliability of information available from the worldwide web. This is
particularly relevant in the area of vaccine safety, where a high number of websites provide incomplete
or misleading information, including unfounded rumours or fraudulent research. This can lead to
undue fears und uncertainties among the general public and undermine immunization programmes.
The Uppsala Monitoring Centre136 maintains for the WHO Programme for International Drug Monitoring,
a global data base of individual case safety reports, called VigiBase, which can be accessed by
member countries of the programme in order to verify if similar issues have been identified elsewhere
with a particular vaccine product.
134
World Health Organization (WHO). Global Advisory Committee on Vaccine Safety (GACVS) [website]. Accessible at: http://www.who.
int/vaccine_safety/initiative/communication/network/_gacvs/en/.
135
World Health Organization (WHO). Vaccine safety net. Accessible at: http://www.who.int/vaccine_safety/initiative/communication/
network/vaccine_safety_websites/en/.
136
Uppsala Monitoring Centre https://www.who-umc.org/
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CHAPTER 6.
CAPACITY BUILDING FOR VACCINE SAFETY
COMMUNICATION SYSTEMS
6.1. Skills and capacity requirements
People working on vaccine safety communication require a set of critical skills and capacities
(see Checklist 6.1). The communication system needs to support the application of these skills
with appropriate structures and processes within the organization. More than one person may be
required to cover all what is required, and a team will be needed in large organizations. In addition
to technical communication skills, the overall mind set and empathy as well as emotional and
relationship intelligence are specifically crucial for anybody working vaccine safety communication,
requiring qualities of imagination, openness and appropriate behaviours. Empathy is the ability to
understand and share the feelings of another;137 this must be based on knowledge of what individuals
or groups are thinking and feeling. No communication or information, however creative, colourful or
modern, will reach and influence audiences unless this essential understanding and connection is
made. The connection is supported through research, engagement and dialogue with the audiences.
Checklist 6.1: Skills and capacity requirements for vaccine safety communication
5
5 Alert, listening, agile and responsive mind set
5
5 Sensitive, contextualizing, far-seeing and proactive approach
5
5 Understanding of the communication sciences and operations for an overall professional
approach
5
5 Ability to develop and apply quality management to communication processes
5
5 Decision-making and implementation abilities
5
5 Ability to establish and maintain strong, honest and trusted networks at community, expert
and policy levels
5
5 Knowledge and understanding of the medical and scientific issues as well as the social,
political, economic, religious and cultural issues, and of how these issues affect risk
perceptions and vaccination decisions in different groups
5
5 Skills in reviewing and interpreting media debates
5
5 Empathy and the ability to tailor messages meeting the audiences’ differential needs in
terms of information content, presentation and tone,
5
5 Ability to act in ways that show the audiences that they are understood and taken seriously
5
5 Ability to communicate in a clear, honest and transparent manner at eye level with the
people and communities addressed
137 Oxford Dictionary. Accessible at https://en.oxforddictionaries.com/definition/empathy, Accessed on 10 November 2016.
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5
5 Knowledge of information technology, keeping up with developments of new and social
media and ‘big data’ in terms of technology and their use by the different audiences
5
5 Ability to prevent and manage crisis situations
5
5 Ability to evaluate and judge the effectiveness of communication interventions with a view
to continuous improvement
Source: Bruce Hugman, Consultant, Uppsala Monitoring Centre.138
6.2. Contents and objectives of training
The structure of training events for vaccine safety communication systems can be based on the
modular curriculum for teaching pharmacovigilance, issued jointly by WHO and the International
Society of Pharmacovigilance (ISoP), which contains a module on communication. This module
recommends teaching content in four areas that can be filled with vaccine-specific training content.
(see Table 6.2).139 Training courses should also be adapted to different and emerging vaccine safety
situations, and be tailored to the needs of the participants and their different roles.
Table 6.2: Curriculum for vaccine safety communication
Area (WHO-ISOP) Topics (adapted from WHO-ISOP)
1. Context and guidance Public health goals, immunization policies, life-cycle safety
management of vaccines, vaccine sentiments, cognitive
concepts, guidance documents relevant to vaccine safety
communication, vaccine safety communication systems,
communication plans, crisis prevention and management, legal
considerations, skills requirements
2.
Communication with patients and
healthcare professionals: tools,
channels and processes
Individual and mass communication, participation of the public,
tools and channels for listening/understanding audiences,
messaging and obtaining feedback data for evaluation
3.
Communication with patients and
healthcare professionals: contents and
presentation
Tailoring for target populations, including parents, selection and
presentation of data, information elements and structure of the
text, typical (tested) subject-matters and recommendations
4.
Interaction among stakeholders
including the media
Communication for involvement of the stakeholders in
pharmacovigilance processes and communication planning,
interaction with scientific and general media, press
conferencing interactions between parties for evaluating
communication
138
Hugman B. Expecting the worst. Uppsala: Uppsala Monitoring Centre; 2010.
139 Beckmann J, Hagemann U, Bahri P, Bate A, Boyd IW, Dal Pan GJ, Edwards BD, Edwards IR, Hartigan-Go K, Lindquist M, McEwen
J, Moride Y, Olsson S, Pal SN, Soulaymani-Bencheikh R, Tuccori M, Vaca CP, Wong IC. Teaching pharmacovigilance: the WHO-ISoP
core elements of a comprehensive modular curriculum. Drug Saf. 2014, 37:743–759.
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Training should enable the participants to:
f
f understand the specificities of communicating on vaccine benefit-risk profiles, vaccine licensure
and launch, routine immunization, mass immunization campaigns and public health emergencies;
f
f define communication objectives and desired outcomes;
f
f engage with and analyse audiences;
f
f develop strategic vaccine safety communication plans;
f
f interact efficiently with colleagues specialized in information technology;
f
f communicate in practice, including in crisis situations;
f
f confidently deal with the media.
Trainings should share knowledge and develop skills through plenary presentations, facilitated
discussions, case-based group work, practical tasks and simulation exercises of real life situations.
Innovative learning methods should be used, as they may be developed in the future. Accessing and
using reliable vaccine safety information efficiently needs to be practiced too. The Vaccine Safety
Net of WHO is one information major source for public health authorities, health professionals and
the public.140 Interpersonal communication skills need to be addressed as a key skill in all areas
of vaccine safety communication. During training, national communication policies and processes
may be tested and improved.
Example 6.2.1: Training programme on vaccine safety communication by the WHO
Regional Office for Europe (WHO-EURO)
An exclusive vaccine safety communication course has been developed by the WHO Regional
Office for Europe to improve the capacity, quality and effectiveness of communication responses
to vaccine safety-related events with a focus on improving decision-making, response time
and quality in responding to these events, including situations where real or perceived adverse
events are affecting trust and confidence. The training programme draws on evidence from
social psychology and communication science as well as case examples and lessons learned
in countries.141
Example 6.2.2: Training resources of the Network for Education and Support in
Immunisation (NESI)
The Network for Education and Support in Immunisation (NESI) was officially launched on 1
September 2002. NESI was built on the experience of the International Network for Eastern
and Southern Africa on Hepatitis B Vaccination, which was established in 1999 and included
five universities in Eastern and Southern Africa (Kenya, Tanzania, Zambia, Zimbabwe and
South Africa), Ministries of Health in Africa and the University of Antwerp. The purpose of this
network was to translate research on hepatitis B through capacity building and advocacy into
universal access to hepatitis B vaccination in the partner countries.
140
WHO Vaccine Safety Net. Accessible at: http://www.who.int/vaccine_safety/initiative/communication/network/vaccine_
safety_websites/en/.
141
The theoretical background and the stepwise guidance are available in the WHO-EURO ‘vaccination and trust’ online library: euro.
who.int/vaccinetrust.
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With the development of new vaccines and increased commitment by development partners
and private sector initiatives to strengthen vaccine supply and immunization services, there
are more opportunities to prevent additional diseases in larger numbers of infants, children,
adolescents and adults. This led to the establishment of NESI, which is a collaborative network
focusing on capacity building for the strengthening of existing immunization systems and
introduction of new vaccines, with a broad technical scope and wide geographical focus.142
6.3. Comprehensive approach to capacity building
In general, capacity building has been defined as the creation of an enabling environment with
appropriate policy and legal frameworks, institutional development, including community participation
(of women in particular), human resources development and strengthening of managerial systems.143
The fundamental goal of capacity building is to enhance the ability to evaluate and address the
crucial questions related to policy choices and modes of implementation among development
options, based on an understanding of environment potentials and limits and of needs perceived by
the people of the country concerned. It encompasses the country’s human, scientific, technological,
organizational, institutional and resource capabilities.144
Any capacity building programme will therefore be specific to regions and countries, but should
also provide for global learning between regions. For vaccine safety communication, it should be
integrated with other capacity building conducted by countries for immunization strengthening as
well as for pharmacovigilance, and public health and regulatory system strengthening.
142 Network for Education and Support in Immunisation (NESI). Accessible at: http://www.nesi.be/about-us/about-us.
143 United Nations Development Programme (UNDP). UNDP Briefing Paper. New York: UNDP, 1991.
144
United Nations Conference on Environment and Development (UNCED). Capacity building. In: UNCED. Agenda 21, Rio de Janeiro:
UNCED, 1992: Chapter 37.
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ANNEX 1:
READING LIST
Below is a list of official guidance documents, major reports and scientific journal publications for reading
and gaining further knowledge on specific aspects relevant to vaccine safety communication systems.
This short list is provided in addition to the broader literature referenced in the footnotes of this report.
Vaccine risk communication
US Institute of Medicine, Vaccine Safety Forum. Risk communication and vaccination: summary of a
workshop. Washington, DC: National Academy Press, 1997. Accessible at: https://www.nap.edu/
catalog/5861/risk-communication-and-vaccination-workshop-summary.
World Health Organization Regional Office for Europe (WHO-EURO). Vaccination and Trust. How concerns
arise and the role of communication in mitigating crises. Copenhagen: WHO-EURO; 2017. Accessible
at: http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/
publications/2017/vaccination-and-trust-2017.
World Health Organization Regional Office for Europe (WHO-EURO). Vaccination and trust library.
Copenhagen: WHO-EURO, 2017. Accessible at: http://www.euro.who.int/en/health-topics/disease-
prevention/vaccines-and-immunization/publications/vaccination-and-trust.
WHO Collaborating Centre (WHO-CC) for Advocacy & Training in Pharmacovigilance. Vaccine
pharmacovigilance toolkit. Accra: WHO-CC for Advocacy & Training in Pharmacovigilance, 2013.
Accessible at: http://vaccinepvtoolkit.org.
European Medicines Agency (EMA) and Heads of Medicines Agencies. Guideline on good pharmacovigilance
practices – product- or population-specific considerations I: vaccines for prophylaxis against infectious
diseases. London: EMA, 2013. Accessible at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/
regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac058058f32c.
Accelerated Development of Vaccine beNefit-risk Collaboration in Europe (ADVANCE). Developing
Communication Strategies on Vaccine Benefits and Risks. ADVANCE, 2017. Accessible at: http://
www.advance-vaccines.eu/?page=publications&id=DELIVERABLES.
Larson H. The globalization of risk and risk perception: why we need a new model of risk communication
for vaccines. Drug Saf. 2012, 35: 1053-1059.
Vaccine hesitancy
World Health Organization Regional Office for Europe (WHO-EURO). Guide to Tailoring Immunization
Programmes. Copenhagen: WHO-EURO; 2013. Accessible at: http://www.euro.who.int/en/health-
topics/disease-prevention/vaccines-and-immunization/activities/tailoring-immunization-programmes-
to-reach-underserved-groups-the-tip-approach.
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Jarret C, Wilson R, O’Leary M, Eckersberger E, Larson HJ; SAGE Working Group on Vaccine Hesitancy.
Strategies for addressing vaccine hesitancy: a systematic review. Vaccine 2015; 33: 4180-4190.
Schuster M, Duclos P, eds. WHO Recommendations Regarding Vaccine Hesitancy. Vaccine [special
edition]. 2015, 33 (34): 4155-4218. Accessible at: http://www.sciencedirect.com/science/
journal/0264410X/33/34.
Peretti-Watel P, Larson HJ, Ward JK, Schulz WS, and Verger P. Vaccine hesitancy: clarifying a
theoretical framework for an ambiguous notion. PLOS Currents Outbreaks, 2015 Feb 25. Edition 1.
Larson HJ, Jarret C, Eckersberger E, Smith DM, Paterson P. Understanding vaccine hesitancy around
vaccines and vaccination from a global perspective: a systematic review of published literature, 2007-2012.
Vaccination trust-building
World Health Organization Regional Office for Europe (WHO-EURO). Vaccination and trust: How
concerns arise and the role of communication in mitigating crises. Copenhagen, Denmark: WHO-
EURO, 2017. Accessible at: http://www.euro.who.int/__data/assets/pdf_file/0004/329647/
Vaccines-and-trust.PDF?ua=1
World Health Organization Regional Office for Europe (WHO-EURO). Vaccination and trust library.
Copenhagen, Denmark: WHO-EURO, 2017. Accessible at: http://www.euro.who.int/en/health-topics/
disease-prevention/vaccines-and-immunization/publications/vaccination-and-trust.
United Nations Children’s Fund (UNICEF) Regional Office for South Asia. Building trust and responding
to adverse events following immunisation in South Asia. Kathmandu: UNICEF South Asia, 2005.
Accessible at: http://www.unicef.org/rosa/Immunisation_report_17May_05(final_editing_text).pdf.
European Centre for Disease Prevention and Control (ECDC). Communication on immunisation:
building trust. Stockholm: ECDC, 2012. Accessible at: http://ecdc.europa.eu/en/publications/
Publications/TER-Immunisation-and-trust.pdf.
United Nations Children’s Fund (UNICEF). Building trust in immunization: partnering with religious leaders and
groups. New York: UNICEF; 2004. Available at: https://www.unicef.org/publications/index_20944.html.
Risk perception and communication
Bennett P, Calman K, Curtis S, Smith D. Risk Communication and Public Health. 2nd ed. Oxford:
Oxfird University presss; 2010.
Kasperson RE, Renn O, Slovic P, Brown HS, Emel J, Goble R, et al. The social amplification of risk:
a conceptual framework. Risk Analysis. 1988, 8: 177-187.
Morgan MG, Fischhoff B, Bostrom A, Atman CJ. Risk communication: a mental models approach.
Cambridge: Cambridge University Press, 2002.
Slovic P. The feeling of risk: new perspectives on risk perception. London, Washington DC: Earthscan, 2010.
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Health communication and health literacy
Rimal RN, Lapinski MK. Why health communication is important in public health. Bulletin of WHO.
2009, 87: 247-247. Accessible at: http://www.who.int/bulletin/volumes/87/4/08-056713/en/.
US Centres for Disease Control and Prevention (CDC). Health communication and social marketing.
Atlanta: CDC, 2014. Accessible at: https://www.thecommunityguide.org/sites/default/files/assets/
What-Works-Health-Communication-factsheet-and-insert.pdf.
US Centres for Disease Control and Prevention (CDC). Health literacy [webpage]. Atlanta: CDC,
2016. Accessible at: https://www.cdc.gov/healthliteracy/basics.html.
Waisbord S, Larson H. Why invest in communication for immunization: evidence and lessons learned.
Baltimore, New York: Health Communication Partnership based at Johns Hopkins Bloomberg School
of Public Health, Center for Communication Programs and the United Nations Children’s Fund
(UNICEF), 2005. Accessible at: http://www.who.int/immunization/hpv/communicate/why_invest_
in_communication_for_immunization_unicef_healthcommunicationspartnership_path_usaid.pdf.
Strategic health communication
The Health Communication Capacity Collaborative. The P-process: five steps to strategic communication.
Baltimore: Johns Hopkins Bloomberg School of Public Health Center for Communication Programs, 2003.
Accessible at: http://www.who.int/immunization/hpv/communicate/the_new_p_process_jhuccp_2003.pdf.
O’Sullivan GA, Yonkler JA, Morgan W, Merritt AP. A field guide to designing a health communication
strategy. Baltimore, MD: Johns Hopkins Bloomberg School of Public Health, Center for Communication
Programs: March 2003. Accessible at: http://ccp.jhu.edu/documents/A%20Field%20Guide%20
to%20Designing%20Health%20Comm%20Strategy.pdf.
Minister of Health Canada. Strategic risk communications framework for Health Canada and the
Public Health Agency of Canada. Ottawa: Minister of Health Canada, 2007. Accessible at: https://
www.canada.ca/en/health-canada/corporate/about-health-canada/activities-responsibilities/risk-
communications.html.
Fischhoff B, Brewer NT, Downs JS. Communicating risks and benefits: an evidence-based user’s
guide. Silver Spring: US Food and Drug Administration, 2009. Accessible at: http://www.fda.gov/
downloads/AboutFDA/ReportsManualsForms/Reports/UCM268069.pdf.
Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-
driven strategies. Drug Saf. 2010, 33: 1065-1079.
Development of communication materials
US Centres for Disease Control and Prevention (CDC). CDC clear communication index. Atlanta:
CDC, 2014. Accessible at: http://www.cdc.gov/ccindex/.
Nelson DE. Communicating public health information effectively: a guide for practitioners. Washington,
DC: American Public Health Association, 2002.
Hugman B. Healthcare communication. London: Pharmaceutical Press, 2013.
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Health information technology
U.S. Department of Health and Human Services (HHS). Health communication and health information
technology [webpage]. Washington, DC: HHS, 2017. Accessible at: https://www.healthypeople.
gov/2020/topics-objectives/topic/health-communication-and-health-information-technology.
Interacting with the news media and social media
World Health Organization Regional Office for Europe (WHO-EURO). Vaccine safety events: managing
the communications response. Copenhagen: WHO-EURO, 2013. Accessible at: http://www.euro.
who.int/en/health-topics/communicable-diseases/influenza/publications/2013/vaccine-safety-events-
managing-the-communications-response.
US Centres for Disease Control and Prevention (CDC). Health communicator’s social media toolkit.
Atlanta: CDC, 2011. Accessible at: http://www.cdc.gov/healthcommunication/toolstemplates/
socialmediatoolkit_bm.pdf.
US Centres for Disease Control and Prevention (CDC). CDC’s guide to writing for social media.
Atlanta: CDC, 2012. Accessible at: http://www.cdc.gov/socialmedia/tools/guidelines/pdf/
GuidetoWritingforSocialMedia.pdf.
Interactions between regulatory authorities and
patient/consumer and healthcare professional
organizations
European Medicines Agency (EMA). Revised framework for interaction between the European Medicines
Agency and patients and consumers and their organisations. London: EMA, 2014. Accessible at:
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/12/WC500018013.pdf.
European Medicines Agency (EMA). Revised framework for interaction between the European Medicines
Agency and healthcare professionals and their organisations. London: EMA, 2016. Accessible at:
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/12/WC500218303.pdf.
Crisis management and communication
Hugman B. Expecting the worst. Uppsala: Uppsala Monitoring Centre, 2010. Extract accessible
at: http://vaccinepvtoolkit.org/pv-toolkit/communication-and-crisis-management-in-vaccine-
pharmacovigilance/#tab-id-1.
World Health Organization Regional Office for Europe (WHO-EURO). Vaccine safety events: managing
the communications response. Copenhagen: WHO-EURO, 2013. Accessible at: http://www.euro.
who.int/en/health-topics/communicable-diseases/influenza/publications/2013/vaccine-safety-events-
managing-the-communications-response.
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Capacity-building
Public Health Agency of Canada. Core competencies for public health in Canada. Ottawa: Public
Health Agency of Canada, 2008. Accessible at: http://www.phac-aspc.gc.ca/php-psp/ccph-cesp/
pdfs/cc-manual-eng090407.pdf.
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ANNEX 2:
CONTRIBUTION TO THE CIOMS GUIDE TO
ACTIVE VACCINE SAFETY SURVEILLANCE
Communication for active surveillance studies
145
A major part of conducting a study is communicating with all involved parties and the general public,
including the media. Communicating is likewise crucial for those authorizing and overseeing the
study conduct. It is crucial to communicate with policy-makers, including legislators and politicians,
to ensure continued support from national authorities for well-designed studies. The communication
process should commence early, when designing the study and obtaining ethical and community
approval prior to its start. Clarity and common agreement on the study objectives is key in this respect.
Communication requires setting up a network and mechanisms for multi-party interactions and in
particular exchange with the concerned communities, as well as maintaining these interactions
throughout the study process. Listening is an essential part of communication, a key component which
promotes understanding. Listening should address questions or concerns raised by the concerned
communities and stakeholders, both proactively in the protocol and during the conduct of the study.
Communication materials, such as informed consent forms, should be adapted to the target audience
in their information content, presentation and tone. Experience has shown that objectives, risks and
ethical standards of studies can be questioned from inside and outside the concerned communities,
even when a study is already ongoing. Without continuous preparedness and responsiveness of the
communication system at any point in time, this may lead to a crisis of trust and premature ending
of a study to the disadvantage of individual and community health. This may happen when an AEFI
occurs or a new risk is identified, but also due to other concerns of the public.
The practical aspects of conducting studies described below mention at which stages communication
becomes particularly important. A specific section gives recommendations for communicating study
findings. The fundamental guiding principle for communication is honesty about expected benefits,
risks and uncertainties. Persons in charge of communication should be well trained and approach
these activities in an alert, empathetic and professional manner.
Communication of study findings
The recommendations for communication for active surveillance studies above should be applied
for communicating the study findings. The objectives of this part of the communication process
are to provide information about the safety and benefit-risk balance, in order to support decision-
making for immunization policies and individual informed choice in relation to immunization, and to
support the safe and effective use of vaccines. Best communication practices, developed by the
health communication sciences, for lingual, numerical and visual expression of the findings should
be followed. The public also needs to receive explanations on the study rationale and be enabled to
145
Council for International Organizations of Medical Sciences (CIOMS). CIOMS Guide to Active Vaccine Safety Surveillance (report of
the CIOMS Working Group on Vaccine Safety). Geneva: CIOMS, 2017, Chapter 4, section 4.1 Communication for the conduct of
AVSS, p.45 and section 4.6 Communication of study findings, p.54.
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understand the robustness and the credibility of the data and their analysis, including the trustworthiness
of those having conducted and overseen the study. This requires an in-depth understanding of the
knowledge and sentiments prevalent in the public and pre-testing of information materials for assuring
that they meet the communication objectives. A media conference should be considered to present
the results and answer questions. The wider dissemination of the study results should reach those
who need to know. Contact points for questions from the public should be in place.
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CIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
ANNEX 3:
MEMBERSHIP, EXTERNAL REVIEWERS,
AND MEETINGS
The CIOMS Working Group on Vaccine Safety (WG) was formed in 2013 following the completion
of CIOMS/WHO Working Group on Vaccine Pharmacovigilance to continue addressing unmet needs
in the area of vaccine pharmacovigilance and specifically address Objective #8 of WHO’s Global
Vaccine Safety Initiative regarding public-private information exchange. The original composition of
the group consisted of experts from regulatory, public health, academia, and industry.
The WG met in a series of eight meetings from May 2013 through March 2016. Some representatives
changed during the years according to organizational and professional developments.
The seven members of the Editorial Team on the CIOMS Guide to Active vaccine safety surveillance
were: Steven R. Bailey (Editor-in-Chief), Novilia Bachtiar, Irina Caplanusi, Frank DeStefano, Corinne
Jouquelet-Royer, Paulo Santos, and Patrick Zuber. CIOMS staff and advisors who supported this
WG include: Lembit Rägo, Gunilla Sjölin-Forsberg, Ulf Bergman, Karin Holm (Technical Collaboration
Coordinator and CIOMS In-house Editor), Amanda Owden, and Sue le Roux.
The WG developed into three main topic groups (TG) with associated deliverables and leaders as
follows:
Topic Group Deliverable Leadership
TG1 on Essential Vaccine
Information (Appendix I of the
Guide to AVSS) –
Appendix I of CIOMS Guide to
AVSS
Ulrich Heininger (final stage)
David Martin (early stage)
TG2 on Active Vaccine Safety
Surveillance
CIOMS Guide to AVSS
(Steven Bailey, WG Editor-in-
Chief)
Steven Bailey, Mimi Darko,
Corinne Jouquelet-Royer (final
stage)
Françoise Sillan (early stage)
TG3 on Vaccine Safety
Communication
CIOMS Guide to Vaccine Safety
Communication
(Priya Bahri, Editor)
Priya Bahri (final stage)
Ken Hartigan-Go (first stage)
Felix Arellano (initial stage)
During the course of its work, topic group 3 evolved in its focus. Its genesis started from the first
WG meeting in London when vaccine crisis management arose as an area needing greater public-
private interaction, with Felix Arellano serving as topic group leader initially. When he later changed
affiliations, Ken Hartigan-Go assumed leadership and broadened the scope of the topic group.
Subsequently, Hartigan-Go passed leadership to Priya Bahri who stepped in to lead the topic group
in late 2015 and forged a new direction based on member and broader stakeholder input.
The table below shows a cumulative list of WG members who have been important contributors to
TG3 on communication over the last four years, organized alphabetically by last name, and their
associated organizations. These contributors have served as members or alternates in the Working
Group for differing periods of time; some have contributed for the full duration (2013 to 2017), while
Annex
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others have attended at least one meeting and/or contributed to TG3’s development. In some cases
organizations changed names over the course of this project or contributors changed affiliations;
this is not always reflected in the listing. The list generally includes the affiliation of the contributor
during the time he or she participated in the topic group. Unless indicated otherwise the comments
from external reviewers were considered as expert, personal opinions and not necessarily representing
those of their employers or affiliations.
CIOMS Working Group on Vaccine Safety — Topic Group 3 on Vaccine Safety
Communication – Active members and affiliations
WG Member Name Organization (Stakeholder group)
1. Abdoellah,
Siti Asfijah
Indonesia National Agency of Drug and Food Control (Regulatory
authority)
2. Arellano, Felix Merck (Pharma industry)
3. Bachtiar, Novilia Bio Farma Indonesia (Pharma industry)
4. Bahri, Priya European Medicines Agency (Regulatory authority)
5. Bergman, Ulf Council for International Organizations of Medical Sciences (CIOMS,
Senior Adviser)
6. Chandler, Rebecca Uppsala Monitoring Centre (Independent foundation and WHO
Collaborating Centre)
7. Chua, Peter Glen Philippines FDA (Regulatory authority)
8. Darko, Mimi Delese Ghana Food and Drug Authority (Regulatory authority)
9. Dodoo, Alexander University of Ghana (Academia) and WHO Collaborating Centre for
Advocacy and Training in Pharmacovigilance
10. Hartigan-Go, Ken Philippines Dept of Health (Public health authority), Asian Institute of
Management
11. Lindquist, Marie Uppsala Monitoring Centre (Independent foundation and WHO
Collaborating Centre)
12. Santos, Paulo Bio-Manguinhos / Fiocruz (Government pharma)
13. Zuber, Patrick World Health Organization (U.N. specialized agency for health)
CIOMS Working Group on Vaccine Safety meetings*
Date Location Host
1. May 2013 London, UK European Medicines Agency
2. September 2013 Geneva, Switzerland World Health Organization
3. February 2014 Atlanta, Georgia, USA Centers for Disease Control
and Prevention
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Date Location Host
4. May 2014 Uppsala, Sweden Uppsala Monitoring Centre
5. September 2014 Rabat, Morocco Centre d’Antipoison et
Pharmacovigilance de
Maroc
6. May 2015 Lyon, France Sanofi Pasteur
7. September 2015 Collegeville,
near Philadelphia,
Pennsylvania, USA
Pfizer
8. March 2016 Accra, Ghana Ghana Food and Drug
Authority
*
Costs for travel to face-to-face meetings and accommodation were covered by each Working Group
member’s parent organization or by CIOMS as per rules, and were not covered by the meeting
hosts. Numerous virtual meetings by teleconference were arranged and covered both by CIOMS
as well as by member organizations.
The editors solicited feedback from outside experts and WHO staff for the later drafts. During the
public consultation via the CIOMS website from 28 August to 11 October 2017, comments were
received from experienced institutions and public health/vaccine communication experts. Their
comments were welcoming and supportive to the report, and clarifications on the recommendations
and updates to some of the references, as well as additions to the reading list have been implemented
in the final report in response to the comments. CIOMS thanks those who commented for their time
and support.
CIOMS Working Group on Vaccine Safety — Vaccine Safety Communication –
External contributors, reviewers, and public consultation
Name Organization
1. Bruce Hugman Uppsala Monitoring Centre, Sweden
2. Katrine Bach
Habersaat
WHO Regional Office for Europe, Copenhagen, Denmark
3. Patrick Zuber WHO Vaccine Safety
4. Madhav Ram
Balakrishnan
WHO Vaccine Safety
5. Heidi Larson London School of Hygiene & Tropical Medicine, UK (during public
consultation commented in private capacity)
6. Jeanet Kemmeren National Institute for Public Health and the Environment (Netherlands)
(during public consultation commented for the organization)
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Name Organization
7. Julia Tainijoki-Seyer World Medical Association (during public consultation commented
for the organization)
8. Robert Pless Health Canada (during public consultation commented in private
capacity)
9. Steve Anderson U.S. Food and Drug Administration, Office of Biostatistics and
Epidemiology, CBER (during public consultation commented for the
organization)
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CIOMS GUIDE TO ACTIVE VACCINE SAFETY SURVEILLANCE
Copyright © 2018 by the Council for International Organizations of
Medical Sciences (CIOMS)
CIOMS Guide to vaccine safety communication. Report by topic group
3 of the CIOMS Working Group on Vaccine Safety. Geneva, Switzerland:
Council for International Organizations of Medical Sciences (CIOMS),
2018.
All rights reserved. CIOMS publications may be obtained directly from
CIOMS using its website e-shop module at https://cioms.ch/shop/.
Further information can be obtained from CIOMS P.O. Box 2100, CH-
1211 Geneva 2, Switzerland, tel.: +41 22 791 6497, www.cioms.ch,
e-mail: info@cioms.ch.
CIOMS publications are also available through the World Health
Organization, WHO Press, 20 Avenue Appia, CH-1211 Geneva 27,
Switzerland.
The CIOMS Guide to Vaccine Safety Communication provides an overview
of strategic communication issues faced by medicines regulators, those
responsible for vaccination policies and programmes and other stakeholders
including: (1) the launch of newly-developed vaccines for the first time to
market, (2) the introduction of current or underutilized vaccines into new
countries, regions, or populations, and (3) the handling of any new safety
issue arising during the life-cycle of a vaccine.
Sourcing from existing guidance documents and compiling recommendations
relevant from a regulatory perspective, the Guide provides a common ground in
a way that has not been achieved otherwise at global level. The Guide stresses
the fundamental importance of regulatory bodies having a system in place
with skilled persons who can efficiently run vaccine safety communication in
collaboration with stakeholders. It presents information and examples with
colour-coding for quick access to three levels of guidance and offers a CIOMS
template to use to create Vaccine Safety Communication Plan.
9 789290 360919
ISBN: 978-92-9036091-9

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