Reference:
Anderson, S. (2020). CBER plans for monitoring COVID-19 vaccine safety and effectiveness. Vaccines and Related Biological Products Advisory Committee Meeting, FDA.
Summary:
The FDA’s Centre for Biologics Evaluation and Research (CBER) presented its comprehensive strategy for monitoring the safety and effectiveness of COVID-19 vaccines during the VRBPAC meeting on October 22, 2020. The approach involves a lifecycle perspective, incorporating both pre-licensure and post-licensure pharmacovigilance. Manufacturers are required to submit detailed pharmacovigilance plans alongside their Biologics License Application (BLA) or Emergency Use Authorization (EUA). This includes routine passive surveillance via the Vaccine Adverse Event Reporting System (VAERS) and active surveillance programs like the FDA BEST initiative, which partners with the Centers for Medicare & Medicaid Services (CMS). The FDA aims for rapid data access and near real-time surveillance to identify potential adverse events, employing various data sources to evaluate vaccine safety. A collaborative effort with multiple government agencies, including the CDC and NIH, ensures comprehensive monitoring and transparency in
vaccine effectiveness assessments.