The European Medicines Agency (EMA) has established a Vaccine Confidence Advisory Group to address persistent vaccine hesitancy, exacerbated by the COVID-19 pandemic and geopolitical factors. The group's mission is to provide external expert insights to strengthen vaccine confidence and science outreach, focusing on human vaccines for infectious diseases. This initiative is part of EMA's broader Vaccine Outreach Strategy to empower informed vaccination decisions.

The terms of reference, published on 29 April 2026, outline the group's background, mission, scope, objectives, membership, and organization. Key objectives include advising on environmental analysis of vaccine hesitancy and mis/disinformation, contributing to EMA's ongoing initiatives, improving benefit-risk communication (e.g., data visualization), and amplifying public health messages. Members include academics, healthcare professionals, patient organizations, and public health bodies, with no financial ties to pharmaceutical or medical device companies. The group will meet quarterly online, with meeting summaries published on EMA's website.

Policy orientations and trade-offs The advisory group represents a soft governance approach, relying on expert advice rather than binding regulation. This balances the need for independent scientific input with the flexibility to adapt to evolving misinformation patterns. However, the exclusion of members with industry ties may limit access to practical vaccine development insights, potentially slowing the translation of expert advice into actionable communication strategies.

Impact on stakeholders - EU public health authorities: Gain access to independent expert advice to counter vaccine hesitancy, but may face challenges in implementing recommendations without regulatory teeth. - Pharmaceutical companies: Excluded from direct membership, which ensures independence but may reduce industry collaboration on communication efforts. - Healthcare professionals: Benefit from improved benefit-risk communication tools, but may need to adapt to new messaging frameworks. - Patient organizations: Represented in the group, ensuring patient perspectives are included, but their influence may be limited by the advisory nature of the body.

Expected institutional follow-up EMA will publish meeting summaries online, providing transparency. The group's advice is expected to feed into EMA's Vaccine Outreach Strategy and other communication initiatives. No binding regulatory changes are anticipated, but the group's recommendations may influence future EMA guidelines on vaccine communication.

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