Opinion: I’m the FDA point person on COVID-19 vaccines. We’ll make sure they’re safe and effective.

Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, says to encourage trust in any COVID-19 vaccine, FDA must be upfront and transparent about how it will ensure the vaccines adhere to global standards for product quality, safety, and efficacy. Marks notes that in Phase III trials, only an independent monitoring group can access information on which individuals receive a vaccine candidate or an inactive comparator. Safety events are also closely followed, and specifications for success are determined in advance. If the evidence from the clinical trial meets these specifications, the trial can potentially be submitted to FDA in support of a Biologics License Application (BLA) or a request for emergency use authorization (EUA). FDA’s guidance advises manufacturers that the vaccine be at least 50% more effective than the inactive comparator. Marks stresses, “For a COVID-19 vaccine that could be administered to millions of individuals, including healthy people, FDA will only issue an EUA if a vaccine has demonstrated clear and compelling efficacy in a large well-designed phase III clinical trial, much like would be required for a BLA.” He adds, “This process will not be rushed. There will be no shortcuts in developing the relevant phase III efficacy results. Any vaccine showing efficacy must also be very safe.” FDA officials also intend to take any COVID-19 vaccine EUA or BLA submission to public advisory committee meetings for open discussion, which will be live-streamed and whose data will be posted on FDA’s website. “We hope to ensure public confidence in COVID-19 vaccines by being transparent about FDA’s decision-making process,” Marks concludes. “Whether a vaccine is made available through an EUA or through a traditional approval, FDA will ensure that it is safe and effective.”