The European Medicines Agency (EMA) has launched a new communications initiative, designed to inform evidence-based decision-making on vaccines. Vaccine Essentials brings healthcare professionals an accessible summary of vaccine-preventable diseases and explains 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.
‘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 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.
‘In the current environment, where people are looking for information about vaccines, we have a responsibility to share vaccine information which is evidence-based and can be used by the public,’ explained Dr Juan Garcia Burgos, who is the Head of Public and Stakeholder Engagement Department at EMA.
The first Vaccine Essentials factsheet focuses on Meningococcal group B vaccines (MenB). Developed with the European Academy of Paediatrics and based on a peer-reviewed publication, it is designed to support clinicians in discussing the burden of meningitis and how it can be prevented.
‘To ensure that Vaccine Essentials addresses information gaps, it was created with clinicians, and tested with healthcare professionals and the public,’ Dr Garcia Burgos told Vaccines Today. ‘Working with partners also allows this material to reach healthcare professionals across Europe.’
The three-page MenB information digest is the first in what is expected to become a series of Vaccine Essentials publications. 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.
The MenB vaccine can prevent invasive meningococcal disease (IMD) – a serious disease that mostly affects young children, adolescents, and young adults. In 2024, there were 2,263 reported cases of IMD (including 202 deaths) in the European Union/European Economic Area.
The new publication was first launched in English but will be available in other EU languages. Future editions could include measles, RSV, HPV and other vaccine-preventable infections.
Read more
