Ny Times, New York
The United States Food and Drug Administration (FDA) is pushing to approve Pfizer-BioNTech's two-dose Covid-19 vaccine on Monday (Aug 23), 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 authorised to speak publicly about it, cautioned that the approval might slide beyond Monday if some components of the review need more time. An FDA spokesman declined to comment.
The agency had recently set an unofficial deadline for approval of around Labour Day, which falls on Sept 6 this year.
The approval is expected to pave the way for a series of vaccination requirements by public and private organisations who are awaiting firmer regulatory backing 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 authorised 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-19 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 Joe 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-BioNTech is expected to finish submitting data that it says shows a third shot is safe and effective next week.