Prognosis

Pfizer Seeks Full U.S. Approval for Covid-19 Booster Shot

New data show third dose increases protective antibody levels
Pfizer, BioNTech begin rolling Biologics License Application

A Covid-19 Testing And Vaccination Site Reopens As Louisiana Cases Rise — Photographer: Bryan Tarnowski/Bloomberg

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By Riley Griffin

August 25, 2021 at 4:09 PM UTC

Updated on

August 25, 2021 at 5:20 PM UTC

This article is for subscribers only.

Pfizer Inc. and BioNTech SE are seeking full U.S. approval for a Covid-19 booster shot for people 16 and older, asking regulators to sign off on a third dose to quell a rise in infections among vaccinated people.

The companies announced Wednesday that they had started a rolling Biologics License Application with the Food and Drug Administration. Pfizer and BioNTech said they intend to complete submission of the application by the end of the week, bringing them one step closer to clearance for the additional shot.