(259) Getting Prepared for COVID-19 Vaccines: How European Regulators Anticipated the Need for Real-World Evidence

Publication Number: 1304

Background: At the start of the pandemic, preparedness activities were initiated to ensure future support to COVID-19 vaccine monitoring, despite the uncertainty about when these vaccines would become available. Once vaccination campaigns started, the European Medicines Agency (EMA) leveraged its framework contracts with academic organisations and large consortia to tender studies to complement vaccine monitoring activities conducted by different stakeholders at national, European and international levels. Safety studies were implemented to contribute to the evaluation of emerging signals. Later, effectiveness studies were initiated in the context of EMA’s extended mandate on vaccine research under the European Health Union.

Objectives: To describe real-world evidence generation activities implemented by EMA from the early pandemic through national vaccination campaigns, and to discuss lessons learned.

Methods: Selected EMA-tendered studies addressing various research questions were assessed using a common structure: objectives, stakeholders, data sources, design, key findings, methodological and operational challenges, learnings, impact.

Results: Early activities supported the generation of background incidence rates, while pharmacoepidemiological studies on the association between EU-authorised vaccines and several safety and effectiveness outcomes generated data that continue to contribute to the collective evidence supporting the benefit-risk profile of COVID-19 vaccines. Findings highlighted the need for large data sources providing recent exposure, outcome and covariate data; the importance of harmonising methods and understanding their limitations; the challenges related to fast changes in vaccine use and disease epidemiology; the need for rapid turnaround studies; and the challenges to assess the impact of rapid regulatory actions.

Conclusions: Preparedness in the context of a public health emergency is key to develop a framework for agile monitoring of therapeutics and vaccines, able to adapt to a changing environment. In the future, regulatory decision-making will benefit from current initiatives such as DARWIN EU® seeking to develop infrastructures that will allow for studies reporting findings within very tight timelines.