Pfizer, BioNTech apply for full FDA vaccine approval

Pfizer and BioNTech have started a biologics license application (BLA) with FDA for approval of their two-dose mRNA vaccine to prevent Covid-19 in people 16 years of age and older. The companies will be providing the necessary figures to support the BLA on a rolling basis over the coming weeks, with a request for priority review. Once the BLA is complete and formally accepted for review by FDA, the agency can set the Prescription Drug User Fee Act (PDUFA) goal date for a decision.

Currently, the vaccine is available in the US under emergency use authorization (EUA), having been the first Covid vaccine to receive that designation in America, followed by Moderna (also two jabs) and Johnson & Johnson (one shot), respectively. Since then, Pfizer-BioNTech have delivered more than 170 million doses of the vaccine across the country.

Pfizer and BioNTech began the BLA by submitting the nonclinical and clinical data needed to support licensure of the Covid-19 vaccine for use in individuals 16 years of age and older. This includes the most recent analyses from the Phase III clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose.

Pfizer and BioNTech have also submitted an application to expand the current EUA for their vaccine to include adolescents 12 to 15 years of age. The companies plan to submit a supplemental BLA to support licensure of the vaccine in this age group once the mandatory data on six months after receiving the second vaccine dose are available.