FDA Grants Priority Review to Pfizer-BioNTech COVID-19 Vaccine

The pathway for the first potentially marketed COVID-19 vaccine has been streamlined.

The US Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) of Pfizer-BioNTech’s vaccine BNT162b2, for the prevention of COVID-19 in persons aged ≥16 years old.

The FDA will now decide on the regulatory approval of the mRNA vaccine by January 2022, as per the shortened 6-month PDUFA deadline brought on by Priority Review.

The Priority Review, among the most common designations granted to drug and biologic applications submitted to the FDA, comes 2 months after the vaccine developers completed their BLA submission with the inclusion of phase 3 clinical trial data supporting the mRNA vaccine’s efficacy and safety up to 6 months following the second dose.

Pfizer and BioNTech also plan to submit a supplemental BLA (sBLA) for marketed use of BNT162b2 in persons aged 12-15 years, once investigators have accumulated 6-month data supporting the vaccine in the adolescent population. The FDA granted expanded Emergency Use Authorization (EUA) to the vaccine for this population in early May.

BNT162b2 was the first COVID-19 vaccine granted EUA by the FDA in December 2020.

Earlier this month, Pfizer-BioNTech was at strategic odds with the messaging of the national and global health authorities, when the groups differed on the necessity of an authorized third “booster” dose of the mRNA vaccine, for bolstered immunity in previously vaccinated persons.

Just 3 days after the vaccine developers announced intentions to submit real-world clinical data to FDA in an EUA application for a third dose, experts from the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) told Pfizer officials that relevant data supporting a booster COVID-19 dose remains inconclusive.

A joint statement from the FDA and CDC reiterated the sustained efficacy of two-dose mRNA vaccines against preventing COVID-19 severe disease and. They noted that efficacy included “variants currently circulating in the country such as Delta.”

“Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated,” they wrote. “Americans who have been fully vaccinated do not need a booster shot at this time.”