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.”
More articles on pharmacy:
COVID-19 vaccine trial recruiters explain widespread distrust, misinformation among potential enrollees
7 key uncertainties surrounding the COVID-19 vaccine race
Remdesivir cuts COVID-19 recovery time by 5 days, final study data says
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.