FDA expected to approve Pfizer-BioNTech's COVID-19 vaccine by early September: NYT

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FDA expected to approve Pfizer-BioNTech's COVID-19 vaccine by early September: NYT
vials of the Pfizer-BioNTech Covid-19 vaccine are prepared to be administered to front-line health care workers under an emergency use authorization at a drive up vaccination site from Renown Health in Reno, Nevada on December 17, 2020. Patrick Fallon/AFP via Getty Images
  • The FDA is said to be expected to approve the Pfizer-BioNTech COVID-19 vaccine by early September.
  • The "sprint" toward formal approval was first reported by STAT.
  • Formal approval, rather than emergency authorization, could build public confidence in the vaccine.

The Food and Drug Administration is working to approve the Pfizer-BioNTech COVID-19 vaccine by early September, according to The New York Times.

The "sprint" toward formal approval was first reported by STAT.

The pharmaceutical company Pfizer filed its application with the FDA on May 7, and the Times report cited unnamed sources as saying the health regulator was hoping to finish its approval process by Labor Day weekend. As The Times noted, numerous employers are preparing to institute vaccine mandates once the Pfizer-BioNTech vaccine is approved.

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Pressure has mounted on the FDA to safely approve the Pfizer-BioNTech vaccine as the Delta coronavirus variant spreads in the US primarily among unvaccinated people.

The Pfizer-BioNTech vaccine, along with COVID-19 vaccines from Johnson & Johnson and Moderna, currently have emergency-use authorization for use in the US as long as COVID-19 remains a threat.

Some expect full approval - rather than the emergency authorization - to boost public confidence in the jab and persuade some people to get vaccinated.

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