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

Pfizer vaccine
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 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” towards formal approval was first reported by STAT.

The pharmaceutical company filed its application with the FDA on May 7, and the FDA is expected to finish its approval process by Labor Day weekend. According to the report, multiple federal agencies are preparing to institute vaccine mandates once the Pfizer-BioNTech vaccine is approved.

Pressure has mounted on the FDA to safely approve the company’s vaccine as the Delta variant spreads in the US primarily among unvaccinated people, and as the start of the school year nears for children and college students.

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

This story is developing. Check back for updates.