Pfizer-BioNTech Becomes First COVID-19 Vaccine to be Fully Approved by the FDA

The first COVID-19 vaccine has been fully approved by the FDA, according to an announcement made by the agency on Monday.¹

The Pfizer-BioNTech vaccine, BNT162b2, will be renamed Comirnaty and will be available to all individuals 16 years of age and older. The vaccine will also remain available for those 12 to 15 years under the emergency use authorization (EUA), as well as for the administration of a third dose, according to the FDA.

Pfizer and BioNTech began the approval process for their COVID-19 vaccine in early May 2021 after submitting a Biologics License Application (BLA), supported by data submitted on a rolling basis. On May 10, the FDA expanded the Pfizer-BioNTech EUA to include adolescents 12 through 15 years of age.

According to topline results from an analysis through March 13, the vaccine has shown to be 91.3% effective against SARS-CoV-2 for up to 6 months after the second dose. Several recent analyses have demonstrated that a third dose of the Pfizer-BioNTech vaccine may reduce the risk of COVID-19 infection among individuals aged 60 years and older, according to a Reuters report.²

The CDC estimates that 73% of US adults – or around 201 million – have received at least 1 vaccine for COVID-19, with just over 51% of the population fully vaccinated against the virus.¹ The Pfizer-BioNTech vaccine accounts for more than 204 million jabs in the United States alone.

The FDA and health officials hope that the full approval will impart confidence in Americans who have delayed getting their COVID-19 shots due to vaccine hesitancy. “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,” said Janet Woodcock, MD, acting commissioner, FDA, in a news release.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Woodcock said. “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.”

References

1. FDA Approves First COVID-19 Vaccine. News Release. FDA; August 23, 2021. Accessed August 23, 2021. https://content.govdelivery.com/accounts/USFDA/bulletins/2edf3f5.
2. Israel finds COVID-19 vaccine booster significantly lowers infection risk. Reuters. August 23, 2021. Accessed August 23, 2021. https://www.reuters.com/world/middle-east/israel-finds-covid-19-vaccine-booster-significantly-lowers-infection-risk-2021-08-22/.