EMA launches vaccine information initiative

The European Medicines Agency (EMA) has unveiled a new communications effort designed to inform evidence-based decision-making. Vaccine Essentials offers healthcare professionals accessible summaries of how the quality, safety and efficacy of vaccines are evaluated.

The initiative is part of a wider effort to support clinicians and the public in understanding the robust regulatory system that underpins vaccine safety. It shows how regulators require strong evidence to approve vaccines, but also highlights how real-world evidence is collected from millions of doses after vaccines become available to the public.

The first Vaccine Essentials publication focuses on Meningococcal group B vaccines (MenB). MenB vaccines were chosen in part because the story of how they are regulated illustrates the value of combining immunogenicity data (which shows that the vaccine induces an immune response) with real-world effectiveness studies that determine impact of a vaccine in a clinic.

‘In the case on MenB vaccines, by supplementing the initial evidence (pre-approval) with additional data (post-approval), regulators were able to further confirm the vaccines’ safety, effectiveness, as well as their favourable benefit/risk balance,’ the EMA says.

The MenB factsheet was developed with the European Academy of Paediatrics and based on a peer-reviewed publication. ‘MenB vaccines represent a success story on the prevention of a very serious disease mainly affecting infants and teenagers,’ said Dr Hans J. Dornbusch of the European Academy of Paediatrics. ‘In clinical practice, in a child with fever, if all meningococcal immunisation is up to date, the risk of severe illness including meningitis is really low.’

The Agency has also assembled a new advisory group on vaccine confidence, bringing together international experts to advise on how to build and maintain trust in the regulatory system. Rather than championing vaccines per se, the regulator seeks to ensure that important health decisions are taken based on evidence and a sound understanding of science.