Reference:
Anderson, S. (2020). CBER plans for monitoring COVID-19 vaccine safety and effectiveness. Vaccine and Related Biological Products Advisory Committee Meeting Presentation, October 22. FDA.
Summary:
The FDA’s Vaccines and Related Biological Products Advisory Committee meeting on October 22, 2020, provided insights into the agency’s plans for monitoring the safety and effectiveness of COVID-19 vaccines. Dr. Steve Anderson outlined a comprehensive “safety throughout the lifecycle” approach that includes both pre-licensure and post-licensure phases. This involves the submission of pharmacovigilance plans from manufacturers and the implementation of both passive and active surveillance systems, such as the Vaccine Adverse Event Reporting System (VAERS) and the FDA’s Biologics Effectiveness and Safety (BEST) initiative. The monitoring aims to ensure rapid access to data for
real-time surveillance of adverse events, utilising large databases and a variety of healthcare settings. The FDA plans to conduct epidemiological analyses and near real-time studies to address potential safety signals. Coordination with federal partners and sharing of protocols is essential for effective monitoring. Overall, the FDA aims to maintain transparency and public trust in the safety of COVID-19 vaccines.