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Pfizer’s two-dose vaccine nears full approval by FDA

The approval is expected to pave the way for a series of vaccination requirements by public and private organizations who were awaiting final regulatory action before implementing mandates.

By: New York Times |
August 21, 2021 9:57:27 am
A dose of the Pfizer coronavirus vaccine is administered in the Bronx on Aug. 8, 2021. (James Estrin/The New York Times)

Written by Noah Weiland and Sharon LaFraniere

The Food and Drug Administration is pushing to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agency’s planning.

Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the company. The people familiar with the planning, who were not authorized to speak publicly about it, cautioned that the approval might slide beyond Monday if some components of the review need more time.

An FDA spokesperson declined to comment.

The agency had recently set an unofficial deadline for approval of around Labor Day.

The approval is expected to pave the way for a series of vaccination requirements by public and private organizations who were awaiting final regulatory action before implementing mandates. Federal and state health officials are also hoping that an approved vaccine will draw interest from some Americans who have been hesitant to take one that was only authorized for emergency use, a phenomenon suggested by recent polling.

Some universities and hospitals are expected to mandate inoculation once a vaccine is fully approved. The Pentagon earlier this month said it plans to make Covid vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of next month, or sooner if the FDA acts earlier.

Once it obtains the approval, Pfizer-BioNTech is planning to quickly ask the FDA to approve a third dose as a booster shot. The Biden administration on Wednesday announced that fully vaccinated adults should prepare to get booster shots eight months after they received their second doses, beginning Sept. 20. Pfizer is expected to finish submitting data that it says shows a third shot is safe and effective next week.

The FDA last week updated its authorizations of Pfizer-BioNTech’s and Moderna’s vaccine to allow third doses for some immunocompromised people, a decision backed by the Centers for Disease Control and Prevention.

Regulators are still reviewing Moderna’s application for full approval for its coronavirus vaccine, and a decision could come at least several weeks after the one for Pfizer-BioNTech. Moderna is planning to submit its data in support of a booster shot in September.

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