EMA and ECDC announce Vaccine Monitoring Platform research agenda for real-world evidence generation on vaccine use in Europe

Publication of the Vaccine Monitoring Platform research agenda marks an important milestone for the European Commission’s European Health Union initiative and sets out the prioritization, design and implementation of real-world evidence (RWE) studies.

Established in May 2022 as a collaboration between the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), the Vaccine Monitoring Platform (VMP) enables both bodies to coordinate and oversee EU-funded, independent post-authorization studies on the use, safety and effectiveness of vaccines in European Union (EU) and European Economic Area (EEA) countries. The newly published research agenda prioritizes and provides a research framework for those stakeholders, including academia, public health bodies and the pharmaceutical industry studies, looking to initiate RWE studies to expand the knowledgebase for the use of current and future vaccines. As noted in the document, the research agenda will also ‘generate supportive data for the decision-making processes by regulators and the Member States in terms of study planning, immunization programs and vaccination policy making.’

The agenda was drafted by the EMA and ECDC with a focus on six fundamental areas:

1. Data gaps such as long-term monitoring and population impact
2. Changes in vaccine composition such as novel influenza vaccines
3. Support to use during emergencies such as effectiveness and safety of mixed schedules
4. Research breakthrough indicating potential regulatory submission
5. Investigations of safety and effectiveness of novel vaccine platforms
6. Known safety or efficacy/effectiveness concerns such as waning of vaccine effectiveness

Following a review period where the research topics were discussed and prioritized, the research agenda was formally endorsed in July 2023 by the VMP Steering Group, which is made up of senior representatives from the EMA and ECDC.

A number of short-, mid- and long-term topics have been set out in the agenda covering several vaccine programs, including COVID-19, influenza and diphtheria. The agenda ranks the topics according to their perceived priority at the EU/EEA level, which are meant to be addressed first. The document notes that some of the research questions outlined in the agenda are already being studied by the VMP, such as the ECDC Vaccine Effectiveness, Burden and Impact Studies - VEBIS project and EMA-coordinated real-world evidence - RWE studies.

A ’living document’, the VMP will review and revise the research agenda annually to ensure that the research questions are up-to-date and reflect current and emerging vaccination policies across Europe.