Pfizer, BioNTech Ask US Regulators for Full Approval of COVID-19 Vaccine

A woman receives her first dose of the Pfizer COVID-19 vaccine at the mass vaccination site at Ripken Basebal in Aberdeen, Md., on May 5, 2021. Chip Somodevilla/Getty Images

Pfizer and BioNTech are asking drug regulators in the United States for full approval for their COVID-19 vaccines.

The two companies announced on May 7 that they initiated a rolling submission for a biologics license application by submitting nonclinical and clinical data, including the most recent analyses from a phase three clinical trial, to the Food and Drug Administration (FDA) in the coming weeks.