FDA Set to Grant Pfizer’s COVID-19 Vaccine Full Approval Today

The FDA is poised to give the Pfizer/BioNTech COVID-19 vaccine full approval as soon as today.

The vaccine has been authorized for emergency use since Dec. 11, 2020, but it is hoped that full approval will ease the concerns of those who are reluctant to be inoculated with a product that has not been fully approved by the FDA. A full approval will also help underpin vaccine mandates by companies for their employees or by states for their healthcare workers.

After moving up the timeline from early September, the FDA had reportedly aimed to complete its data review and approve the biologics license application (BLA) by last week but was unable to finish the review by then.

Pfizer and BioNTech filed their application for full approval in May and the agency granted it a Priority Review mid-July and said it was pulling out all the stops to reach a timely decision (DID, Aug. 2).

The Biden administration last week unveiled a plan to roll out booster doses of the Pfizer/BioNtech vaccine for adults over 18 years old from Sept. 20 (DID, Aug. 19). ― Jason Scott