CIOMS Guide to Vaccine Safety Communication

This guide from the Council for International Organizations of Medical Sciences (CIOMS) provides an overview of strategic communication issues faced by medicines regulators, those responsible for vaccination policies and programmes, and other stakeholders when dealing with: the launch of newly-developed vaccines for the first time to market; the introduction of current or underutilised vaccines into new countries, regions, or populations; and the handling of any new safety issue arising during the life-cycle of a vaccine.

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. According to CIOMS, few communication guidance documents covering how to manage communication when an adverse event occurs have thus far been issued addressing the specific needs of regulatory bodies - 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 resource aims to fill that gap.

The guide discusses the complexity of vaccine safety communication (see Chapter 2) and builds upon already existing expert 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 summarised, 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. The resource presents information and examples with colour-coding for quick access to 3 levels of guidance; sample examples: Example 3.2.3: The introduction of pentavalent vaccines in Kerala, India, supported by close interactions with the healthcare community and the media; and Example 4.3.1: social media monitoring during polio supplementary immunisation activities (SIAs) in Israel.

More practically, 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). CIOMS feels that 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 that regulators have to be aware of - in particular, tensions between evidence and uncertainty, public trust and mistrust, and vaccine acceptance and vaccine hesitancy (see §2.2 and §2.4). Organised by topics, Annex I guides readers for further learning and training.

Figures throughout include:

• Figure 2.1: The social-ecological model (SEM)
• Figure 2.4: The WHO Strategic Advisory Group of Experts (SAGE) on Immunization Model of determinants of vaccine hesitancy
• Figure 3.2: Risk management cycle
• Figure 4.1: The P-Process of strategic health communication
• Figure 5.3: Relationships of parties in global vaccine safety

CIOMS is an international, non-governmental, non-profit organisation established jointly by the World Health Organization (WHO) and the United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949. CIOMS represents a substantial proportion of the biomedical scientific community through its member organisations. Its mission is to advance public health through guidance on health research including ethics, medical product development, and safety.