The Food and Drug Administration is pushing for approval of Pfizer-BioNTech’s two-dose Covid-19 vaccine on Monday, further accelerating an earlier timeline for licensing the injection, according to people familiar with the injection. office planning.
Regulators were working to complete the process by Friday, but were still dealing with a significant amount of paperwork and negotiations with the company. Those familiar with the schedule, who were not authorized to speak about it publicly, warned that approval could shift after Monday if some parts of the review need 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 range of vaccination requirements by public and private organizations waiting for firmer regulatory support before implementing mandates. Federal and state health officials also hope that an approved vaccine will spark the interest of some Americans who were hesitant to take one that was only approved for emergency use, a phenomenon suggested by recent polls.
Some universities and hospitals are expected to mandate vaccination once a vaccine is fully approved. The Pentagon said earlier this month it plans to mandate Covid vaccinations for the country’s 1.3 million active-duty troops “no later” than the middle of next month, or sooner if the FDA intervenes sooner.
The timing of the approval could lead to an uncomfortable messaging problem for the Biden administration, which announced on Wednesday that fully vaccinated people should prepare to receive booster shots eight months after receiving the second doses. Approving the vaccine while encouraging boosters may create the impression to some that the vaccine as licensed is inadequate without an additional shot.
. The FDA last week updated its vaccine approvals from Pfizer-BioNTech and Moderna to allow third doses for some immunocompromised people, a decision supported 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 weeks after the one for Pfizer-BioNTech.