Vaccine developers hustle to meet FDA data requirements to submit for approval

Despite buzz about a COVID-19 vaccine possibly being available by the end of October, experts say the timetable will actually depend on how many volunteers become infected as Phase III trials progress. Once that number hits 150, study sponsors have a statistical foundation on which to compare outcomes among vaccine recipients vs.

Despite buzz about a COVID-19 vaccine possibly being available by the end of October, experts say the timetable will actually depend on how many volunteers become infected as Phase III trials progress. Once that number hits 150, study sponsors have a statistical foundation on which to compare outcomes among vaccine recipients vs. placebo recipients. If more individuals in the control group become infected and/or develop severe disease than in the active treatment group, the vaccine will likely be deemed effective. Manufacturers may then submit the data to FDA, which will use it to judge whether the vaccine is safe and effective enough for widespread use. The agency stipulated in June that a candidate would have to protect at least one-half of vaccinated people in order to qualify for an Emergency Use Authorization or full regulatory clearance. Pfizer considers itself the front-runner, with 25,000 volunteers out of a targeted 30,000 already joining its Phase III trial. Moderna intends to slow enrollment in order to ensure greater diversity in its study, while other firms have not even started recruiting participants or remain far from full enrollment.