ORCA Webinar – Perspectives on Postmarket Safety Surveillance of Vaccines

This event offers a comprehensive look at the FDA’s approach to vaccine safety monitoring across the full product lifecycle—from pre-market clinical trials to post-market surveillance. It will cover the FDA’s use of both passive systems like the Vaccine Adverse Event Reporting System (VAERS) and active surveillance tools such as the Biologics Effectiveness and Safety (BEST) system and Medicare databases. Experts at the FDA review a wide range of data, including clinical study results, peer-reviewed literature, international sources, and pharmacovigilance plans submitted by manufacturers. These efforts support ongoing updates to vaccine benefit-risk assessments, ensuring public safety and informed regulatory decisions.

Featured speaker Dr. Anderson, former FDA Office Director, will share expert insights from his long career at the agency, including recent experiences managing vaccine safety during the COVID-19 pandemic. He’ll discuss lessons learned and how those insights shape the post-pandemic future of vaccine surveillance. This event is especially relevant for professionals in vaccine development, regulatory affairs, and public health.