Listen to the Public and Fulfil Their Information Interests - Translating Vaccine Communication Research Findings into Guidance for Regulators

"Regulatory authorities have a crucial role in communicating about the vaccines they license. In terms of content and timing, their communication to the public is usually driven by data on quality, safety and efficacy. However, concerns over safety and vaccine hesitancy have emerged in some communities in various countries, and this demands a new approach to communication, starting with listening to the public debate."

Regulatory authorities license vaccines and provide information about quality, safety, and efficacy (QSE) through the product information, public assessment reports and advice, and media statements. This paper summarises guidance issued by the European Union (EU) regulatory network for their communication about the safe use of vaccines with the public, which is meant to be proactive in addressing the information interests of the public. It shares the evidence base for the guidance and frequent information interests of the public identified through a global literature review, putting this guidance in a complementary context of recent further guidance applicable for regulators inside and outside the EU. Finally, it shows that findings from cognitive, decision-making, and media research can be helpful to regulators and advocates for communication research for further classes of medicinal products.

Guidance on developing message content on vaccine safety was issued by the European Medicines Agency (EMA) and the regulatory authorities of the EU member states in December 2013 as part of the EU good pharmacovigilance practices (EU-GVP). Up to that point, there had been "no guide specific to the role of regulatory authorities or pharmacovigilance in communicating about vaccines with the public....Apart from the applicability of the guidance specifically to regulators, the other novelty was how the guidance was developed. It had been recognized that in order to overcome potential mismatches between the delivered information about medicinal products and public information interests, regulators should understand their audiences....The idea emerged that an overview of concerns, knowledge, attitudes and medicinal product use behaviours of populations, as well as related media behaviours, media coverage and public debates, could be obtained from reviewing findings from the cognitive, decision-making and media sciences, and that these research findings could provide a useful basis for guidance. However, it was unclear whether such literature reviews could provide results that were truly useful, and worth the effort, for developing guidance for regulatory authorities. A pilot study was therefore set up at the EMA as a 'proof of concept', taking vaccines as an example and introducing a 'historical simulation' applied to the scientific literature for communication about (H1N1) pandemic influenza vaccines..."

The authors continue: "As the pilot study suggested that findings from communication research can be used by regulators for anticipating questions from the public and preparing communication messages addressing these questions, guidance for vaccine safety communication was developed, based on a worldwide vaccine communication literature search and additional globally relevant key publications (see Appendix)." Table 1 provides a summary of the guidance on vaccine safety communication in the EU good pharmacovigilance practices and its evidence base.

As noted here, the relevance of the guidance for capacity building for regulators outside the EU has been noted at meetings of the World Health Organization (WHO) and international societies. Because "the literature review for the guidance was performed on the worldwide literature and complemented by key publications of global relevance, the resulting guidance is, in principle, applicable in any country of the world. In particular, the role of the local and global news, as well as the social media, is becoming increasingly important, not only for disseminating messages, but also as a tool for real-time listening to the worldwide debate."

Along those lines, due to the fact that the guidance details frequent communication interests of the public identified through communication research, e.g. relating to excipients, pregnancy, or epilepsy, the guidance itself can be considered as based on listening. "Continuous listening to the public has been confirmed as important because public concerns about vaccines are vaccine type-, country- and population-specific, and are subject to change over time."

This focus on listening is tied to the concept of strategic health communication, which provides for objective-focused planning of communication interventions and impact evaluation. The guidance advises a focus on the most frequent public information needs and insists on transparency of evidence-based regulatory decision making. This approach advocates for listening and understanding patients, healthcare professionals and others concerned, and then using this understanding for scoping medicinal product-specific risk assessments and analysing communication options. This requires studying the real-world use of medicines and its drivers, as well as the concerns and questions of those using medicines. This is designed to allow for formulating and contextualising risk messages. For this purpose, the guidance encourages collecting frequently asked questions from the public, conducting media monitoring of the public debate and concerns expressed by subgroups of the public, and implementing public participation in communication planning.

A remaining question is whether strategic communication by regulators will effect change. While overcoming vaccine hesitancy is not a primary communication objective of regulators, the fact that safety concerns are among the main drivers of vaccine hesitancy in the EU makes meeting the information interests of the public important to regulators. Simply filling information gaps based on what has been called the "deficit model" is not sufficient for achieving the communication objectives of the EMA, so the guidance goes beyond merely advising on information provision. It not only explicitly encourages the monitoring of the public debate, but also the application of public participation mechanisms and collaboration with public health authorities, other local stakeholders, and international partners. Further, the guidance stresses the need to provide information that supports healthcare professionals in their interactions with patients.

Since the issuing of the guidance, the EMA has participated in two projects, resulting in further guidance documents based on new research, experience, and expert advice - see Related Summaries, below, for access to one of them. A shared conviction, and one that can drive efforts going forward, is that "Regulators should consider, in their communications, not only the data on QSE, but also an outside perspective - namely, that of those they serve - and respond to what they need and want to know."