The EU Vaccine Monitoring Platform: a New Framework Leveraging European Union Pharmacoepidemiological Expertise and Data Sources to Monitor the Effectiveness and Safety of Vaccines
Background: In order to strengthen the European Union (EU) crisis preparedness and management of cross-border health threats, the European Commission adopted in 2020 a Health Union Proposal, which included the extension of the mandates of the European Medicines Agency and the European Centre for Disease Prevention and Control, resulting in the establishment of a Vaccine Monitoring Platform (VMP) where independent post-authorisation vaccine studies in the EU are coordinated.
Objectives: To describe the development and implementation of the VMP research agenda, and illustrate by selected examples of vaccine studies how it will address evidence gaps in vaccine research in the EU.
Methods: The VMP research agenda was developed building on categories of interest such as disease area, availability of a vaccine, target population, stage of development or lifecycle, vaccination strategy, and need for public health prevention and preparedness. A qualitative analysis facilitated prioritisation of studies based on predefined, weighted criteria such as public health and regulatory relevance and urgency, disease epidemiology, complexity of the required methodology, and real-world data availability.
Results: Studies initially focused on current declared public health emergencies, COVID-19 and (monkeypox) mpox. This research highlighted the need of timely and granular high-quality data on vaccine exposure, outcomes (e.g., variant-specific data) and important confounders. The use of a common data model proved to be an efficient tool to speed up data generation and facilitate the interpretation of heterogeneous results. The COVID-19 vaccination campaign showed the need to address new methodological challenges, taking into account complex vaccination schedules and accounting for time-varying confounders. Vaccine safety and effectiveness evaluation provided robust evidence when different settings or study designs were simultaneously considered, each with their strengths and limitations. The need for timely data to confirm benefits and risks of the mpox vaccine was addressed using a complementary approach of primary data collection and secondary use of data. Selected results from these studies will be discussed.
Conclusions: Preparedness for, and management of vaccine-preventable diseases relies on the availability of suitable data sources and tailored methods, which are key to provide decision-makers with reliable evidence, especially during emergencies.