The FDA’s stricter standards for a COVID-19 vaccine are meant to reassure the public about the safety and efficacy of a vaccine, and end the politicization of vaccine standards, the FDA’s top official for vaccines said Wednesday.
Data from phase III studies with a median follow-up duration of at least 2 months, and at least five severe COVID-19 cases in the placebo group, were standards proposed by the FDA for weeks. These standards were released in briefing documents the FDA made available to the public Tuesday.
Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research, emphasized the importance of tracking safety of the vaccine during an American Medical Association webinar on Wednesday.
“We asked for a median of 2 months of safety follow-up after the final vaccination of the population enrolled in the trial,” he said, explaining that when looking at adverse events, such as