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August 23, 2021

Pfizer-BioNTech COVID Vaccine Wins Full FDA Approval

Pfizer-BioNTech COVID Vaccine Wins Full FDA Approval

The U.S. Food and Drug Administration (FDA) granted full approval to Pfizer and BioNTech’s COVID-19 vaccine for use in adults and teens ages 16-years and older. The August 23 approval comes as the Delta variant is fueling a surge in new cases across the country.

Pfizer’s COVID vaccine, which will be marketed as Comirnaty, will continue to be available under emergency use authorization (EUA) for younger children ages 12 to 15-years old and as a booster dose for certain people with weakened immune systems. 

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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,” said acting FDA commissioner Janet Woodcock, M.D in an August 23 news release.

Top health officials are hoping the move will prompt more people to get vaccinated. They’re also anticipating a wave of new mandates among businesses, universities and other organizations, requiring students, staff or employees to get vaccinated. The U.S. military will also reportedly move to mandate the COVID-19 vaccine for all service members.

 “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,” Dr. Woodcock added. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

In the U.S., as of August 22, only 60 percent of eligible adults and kids are fully vaccinated. Meanwhile, some 29 percent haven’t even gotten one dose. But a June poll conducted by the Kaiser Family Foundation found that 30 percent of unvaccinated adults said that they would be more likely to get their shots if one of the COVID vaccines available in the U.S. were to receive full FDA approval.

The Pfizer mRNA vaccine was the first COVID vaccine granted Emergency Use Authorization (EUA) in the United States in December 2020. It was also the first vaccine to be considered for full U.S. approval.

The difference between EUA and FDA approval?
An Emergency Use Authorization (EUA) from the FDA allows people to gain access to vital new drugs or vaccines during a public health crisis. This process is how all three coronavirus vaccines currently available in the United States—Pfizer, Moderna and Johnson & Johnson—received the initial greenlight for distribution across the country.

Under an EUA, the FDA may allow the use of unapproved treatments to help manage such a threat if certain safety criteria have been met and there are no other approved alternatives. An EUA, however, is only in effect for as long as the public health emergency lasts and can be revoked at any time.

When the FDA approves a drug, the agency has decided that it is effective, and its benefits outweigh its risks. This approval will remain in place even after the public health threat is gone. Once approved, the FDA must request removal if there are any issues concerning a drug’s safety or effectiveness.

In order to receive FDA approval, Pfizer and BioNTech had to demonstrate that their manufacturing processes and facilities can produce their vaccine with quality and consistency. Now that their COVID vaccine is fully FDA-approved, the companies are allowed to market their vaccine in the U.S. directly to consumers.  

Safety monitoring will be ongoing
The FDA's traditional approval process can take years, but Pfizer requested approval based on a “rolling submission,” speeding up the review process by allowing the FDA to review new data as it became available.

In May 2021, Pfizer and BioNTech also asked for Priority Review, which means the FDA’s goal was to take action on the application within 6 months—not 10 months under standard review. Keep in mind, this designation did not change the length of clinical trials, the scientific/medical standards or quality of evidence required for approval.

Now that the vaccine is approved by the FDA, monitoring for its safety and effectiveness doesn’t end. The FDA explains that surveillance will continue to identify any possible rare or long-term complications. So far, the vast majority of reported side effects have been mild.

Vaccines are also closely monitored using various surveillance systems, such as the Vaccine Adverse Event Reporting System (VAERS), the FDA BEST (Biologics Effectiveness and Safety) program and the Centers for Disease Control and Prevention’s (CDC) Vaccine Safety Datalink.

Medically reviewed in August 2021.

Sources:
U.S. Food and Drug Administration. “FDA Approves First COVID-19 Vaccine.” Aug 23, 2021.
Kaiser Family Foundation. “KFF COVID-19 Vaccine Monitor: June 2021.” Jun 30, 2021.
Pfizer. “PFIZER AND BIONTECH INITIATE ROLLING SUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR U.S. FDA APPROVAL OF THEIR COVID-19 VACCINE.” May 7, 2021.
Centers for Disease Control and Prevention. “COVID Data Tracker.” May 6, 2021.
U.S. Food and Drug Administration. “Emergency Use Authorization for Vaccines Explained.” Nov 20, 2020.
U.S. Food and Drug Administration. “Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19.” Dec 22, 2020.
Regulatory Affairs Professional Society. “Why FDA’s Issuance of EUAs are not ‘approvals’ and why that matters.” Apr 3, 2020.
U.S. Food and Drug Administration. “Priority Review.” Jan 4, 2018.
U.S. Food and Drug Administration. “Vaccine Development – 101.” Dec 14, 2020.

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