Introducing the Vaccine Monitoring Platform (VMP) research agenda
The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) have introduced the Vaccine Monitoring Platform (VMP) research agenda, a pivotal step in ensuring the safety and effectiveness of vaccines in EU/EEA immunization programs. This comprehensive agenda outlines crucial areas for expanding research, providing a framework for academia, public health bodies, and the pharmaceutical industry to generate essential knowledge for both current and future vaccines.
The Significance of the Research Agenda
The research agenda serves as a blueprint for studies needed to gather additional knowledge about vaccines in use and those in development. Its primary audience includes academia, public health organizations, and the pharmaceutical industry, acting as a vital resource before embarking on research initiatives. Moreover, the agenda aims to raise awareness among national competent authorities and patient organizations.
Supporting Regulatory Decision-Making
A key objective of the research agenda is to provide data to aid regulators and EU Member States in making informed decisions regarding study planning, immunization programs, and vaccination policy. By addressing specific categories of research topics, the agenda targets critical areas of focus:
- Data gaps for authorized vaccines
- Diseases requiring post-authorization monitoring due to changes in vaccine composition (e.g., flu and COVID-19)
- Enhancing existing vaccines for use during public health emergencies
- Vaccine preparedness, including understanding disease burden
- Post-authorization monitoring to confirm benefit/risk profiles
Endorsement and Evolution of the Research Agenda
The VMP steering group officially endorsed the research agenda in July 2023. It is a dynamic document, continually updated and reviewed annually to align with evolving research priorities and resource availability.
Background and Scope
The VMP is a collaborative effort between EMA and ECDC, aiming to generate independent real-world evidence on vaccine safety and effectiveness. The research agenda provides thematic prioritization, guiding the selection of VMP studies. It supports decision-making processes for regulators and Member States regarding study planning, immunization programs, and vaccination policy.
Conclusion
The Vaccine Monitoring Platform research agenda marks a significant milestone in vaccine safety and effectiveness research. By delineating critical areas for further investigation, it empowers stakeholders to make well-informed decisions that safeguard public health. This dynamic agenda reflects EMA and ECDC's commitment to ongoing research and continual improvement in vaccine safety. Stay tuned for updates as the research agenda evolves to meet the evolving needs of vaccine safety monitoring.
You can find the research questions in the document provided by the EMA:
https://www.ema.europa.eu/en/documents/other/vaccine-monitoring-platform-vmp-research-agenda_en.pdf
