FDA targets full approval of Pfizer Covid vaccine on Monday
The Food and Drug Administration is pushing to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine on Monday, speeding up an earlier deadline for authorization of the shot, according to people familiar with the agency’s planning.
Regulators were working to complete the process by Friday, but were still working on a significant amount of paperwork and negotiations with the company. People familiar with the planning, who weren’t authorized to speak publicly, warned that approval could slip past Monday if certain items on the review require more time.
An FDA spokeswoman declined to comment.
The agency had recently set an unofficial approval deadline around Labor Day.
The approval is expected to pave the way for a series of immunization requirements by public and private organizations awaiting final regulatory action before implementing the mandates. Federal and state health officials are also hoping that an approved vaccine will spark the interest of some Americans who have been reluctant to take one that was only allowed in an emergency, a phenomenon suggested by recent polls.
Some universities and hospitals should require inoculation once a vaccine is fully approved. The Pentagon said this month it plans to make Covid vaccinations mandatory for the nation’s 1.3 million active-duty soldiers “no later than” the middle of next month, or sooner if the FDA acts more early.
Once approval is obtained, Pfizer-BioNTech plans to promptly ask the FDA to approve a third dose as a booster. The Biden administration announced on Wednesday that fully vaccinated adults should prepare for booster shots eight months after receiving their second dose, starting September 20. Pfizer is expected to finish submitting data it says shows a third injection is safe and effective next week. .
The FDA last week updated its authorizations for the Pfizer-BioNTech and Moderna vaccines to allow third doses for some immunocompromised people, a move supported by the Centers for Disease Control and Prevention.
Regulators are still reviewing Moderna’s request for full approval of its coronavirus vaccine, and a decision could come at least several weeks after Pfizer-BioNTech’s. Moderna plans to submit its data in support of a recall in September.