Pfizer-BioNTech Covid-19 Vaccine Granted Full Approval by FDA

A version of this article was originally published to sister publication Contagion.

On Monday, the US Food and Drug Administration (FDA) granted Biologics License Application (BLA) approval to Pfizer-BioNTech for the companies’ COVID-19 vaccine BNT162b2.

About the Vaccine

BNT162b2 is a nucleoside-modified mRNA vaccine which encodes SARS-CoV-2 full-length spike protein glycoprotein and was 1 of the 4 initially assessed COVID-19 vaccines from Pfizer.

BNT162b2 was the first COVID-19 vaccine to be approved by the FDA.

Earlier coverage noted that the Pfizer-BioNTech COVID-19 vaccine, which received an EUA in December 2020, would likely be the first to receive full-approval.

Likewise, Pfizer and BioNTech’s BLA submission was granted Priority Review by the FDA last month, which streamlined he regulatory review and decision-making timeline for the vaccine.

A NY Times report stated that “The FDA’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had ‘taken an all-hands-on-deck approach’ to the work.”

What the Approval Means

The implications of this decision are important. Though the authorization of BNT162b2 allows for greater prescribing capability and will likely drive workplace vaccine mandates, members of the FDA noted that public confidence of the vaccine is still lacking.

FDA Acting Commissioner Janet Woodcock, MD, acknowledged the public's lacking confidence in the vaccines in a statement accompanying the Monday decision.

“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Woodcock said. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated."

Despite factions of the public being skeptical of the vaccine, CDC reiterates the benefit of authorized COVID-19 vaccines in reducing risk of infection, serious illness, and death from the Delta variant, as well as in reducing risk of virus spread from a vaccinated person to others.

Vaccination Strategies

Multiple vaccine regulation strategies are currently at play in the US.

Earlier this month, the FDA granted EUA to Pfizer-BioNTech and Moderna for third “booster” doses of their respective mRNA vaccines in severely immunocompromised patients.

Shortly after, a report revealed the Biden administration’s plan to advocate for COVID-19 vaccine booster dose availability for all Americans at 8 months following their final dose.

Depending on FDA allowance, this would authorize booster doses for the adult general public by mid-September.

It is anticipated that the Moderna and Johnson & Johnson COVID-19 vaccines will also receive full approval in the coming months.