Operation Warp Speed czar: Vaccine approval likely to be sought around Thanksgiving

Moncef Slaoui, PhD, the chief advisor of Operation Warp speed, the White House task force to develop a COVID-19 vaccine, said drugmakers developing COVID-19 vaccines will begin to seek FDA emergency approval around Thanksgiving, according to an Oct. 10 MarketWatch interview with the immunologist.

Dr. Slaoui's estimated timeline comes days after the White House endorsed the FDA's new COVID-19 vaccine authorization guidelines, which require a two-month observation period after clinical trial participants are given the final dose of the vaccine to see if there are any negative side effects. He called the requirement "reasonable" and "a good takeaway."

"We will know if a vaccine works…anytime late October, or November, or in December," Dr. Slaoui told MarketWatch. "But I expect the [emergency use authorization] filing to happen three [or] four weeks after that moment of when we know the vaccine is efficacious. Maybe if we work like crazy we make it happen in two weeks."

FDA guidelines also require that vaccines be at least 50 percent effective in preventing COVID-19. Dr. Slaoui told MarketWatch he expects the vaccines seeking emergency approval in the coming months to be between 80 and 90 percent effective, saying he would be "very negatively surprised if it was closer to 50 percent."

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars