A real-life media listening experience with HPV vaccines at the European Medicines Agency (EMA)

Communicating about benefit-risk assessments of medicines is a major part of the activities of a regulatory body. When vaccines are concerned, communication preparations should be done with specific attention to the regular debates on vaccines in the public domain. In Europe, doubts about safety are the main driver for vaccine hesitancy of individuals for whom vaccines are provided, or their parents.¹ Therefore, the need for vaccine safety communication systems and processes capable of effective stakeholder interactions, preparations and conduct of communication by regulatory bodies, taking into account specific information needs of the public and sub-populations, has been advised for at European Union (EU)² and global level.³

Media monitoring for the purpose of listening to the public has been amongst the long-standing recommendations for communication about medicines in general⁴ as well as medicine-related safety concerns and risk mitigation in particular.⁵ However, the utility of media monitoring for regulatory bodies and whether resource allocation could be justified have been unclear.

When the European Medicines Agency (EMA), in July 2015, started an EU procedure assessing HPV vaccines with regard to the potential causality of complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) reported to the authorities as suspected adverse reactions, the EMA decided to conduct a study with the objective to evaluate the utility of media monitoring in real life.

Prospective daily monitoring of worldwide online news on websites of e.g. online newspapers, news outlets, television stations and consumer organisations was performed. From September to December 2015, 4230 news clips, or posts, were identified (Figure 1), containing personal stories, scientific and policy/process-related topics.

Figure 1. Time chart depicting volume of media coverage worldwide from 7 September to 23 December 2015 by day (generated by the Cision® system).⁶

Through an inductive content analysis, explicit and implicit concerns voiced in these posts were identified and formulated as ‘derived questions’. These derived questions were worded in regulatory-scientific language and abstract manner, i.e. formulated differently from the questions raised explicitly in the media or formulated anew if the concern had not been presented in the media as a question at all, but the discussion implied a question or knowledge gap which was considered, as part of the media content analysis, as important to fill. This included questions that were anticipated to be raised once more information would be available for publication. Medical, methodological as well as integrity-related aspects were discussed in the media. 50 derived questions were generated and categorised into 12 themes, which are presented with the 12 high-level questions in Table 1. Based on the media content from September to 22 October 2015, considerations (weekly) and the 50 questions (two weeks prior to the scheduled assessment outcome) were provided to the colleagues involved in the risk assessment or in the communication planning.

The evaluation was performed through three approaches, and the results showed utility as detailed in Table 2. It was demonstrated that media monitoring can support regulatory bodies in (1) their scoping of risk assessments to ensure public concerns are addressed in the assessments; (2) their communication proactivity through enriching public statements with scientific details and committed, empathic tone; and (3) their preparedness for prompt responses to journalists and at public meetings. Derived questions in scientific-regulatory language seem to be a familiar format and effective, as they make the media debates readily understandable in the regulatory environment and motivate addressing the identified concerns. It is suggested that listening to the public through media monitoring could form part of regular safety surveillance for medicines of high public⁶ interest.

References
1. Karafillakis E, Larson H, on behalf of the ADVANCE consortium. The benefit of the doubt or doubts over benefits?: a systematic literature review of perceived risks of vaccines in European populations. Vaccine 2017;35:4840-50.
2. 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 .
3. 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: CIOMS, 2017.
4. 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.
5. Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf 2010;33:1065-79.
6. Bahri P, Fogd J, Morales D, et al. 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;15:91.