USA – FDA plans master protocols to monitor COVID vaccine safety, efficacy

After a vaccine against COVID-19 is authorized or approved, how will its safety and efficacy be assessed? In addition to ongoing postmarket surveillance requirements, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) will strive for near real-time safety and efficacy surveillance of COVID-19 vaccines.

FDA is currently developing master protocols to guide its safety and effectiveness oversight, said an FDA official during the FDA’s first COVID-19 vaccine-focused advisory committee hearing. “We’ll be posting the protocols for public comment,” said Stephen Anderson, PhD, director of the Office of Biostatistics and Epidemiology at FDA’s Center for Biologics Evaluation and Research (CBER).

Anderson, speaking to the Vaccines and Related Biologics Products Advisory Committee (VRBPAC), reviewed the agency’s resources and plans to track how vaccinated individuals fare, emphasizing the big data approach and resources FDA will draw on as it collaborates with sponsors and CDC to follow the COVID-19 vaccines’ track records. The committee met on 22 October to consider general approaches in authorizing or approving vaccines against COVID-19, without discussing any particular vaccine candidate.

By way of background, Anderson noted that in addition to ongoing passive surveillance through the Vaccine Adverse Event Reporting System (VAERS), the FDA Amendments Act of 2007 directed FDA to come up with a system of active risk identification and analysis. As a result, the Sentinel and Biologics Effectiveness and Safety (BEST) programs now cover over 100 million people. “And that’s the number that we shoot for when we’re doing these types of safety evaluations,” said Anderson…