The U.S. Food and Drug Administration (FDA) has granted full approval to Pfizer-BioNTech’s two-dose COVID-19 vaccine for those ages 16 and older.
“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 a statement.
The Pfizer-BioNTech vaccine, which will now be marketed to consumers as Comirnaty, is still available under emergency use authorization for children ages 12 to 15. Earlier this month, the FDA granted emergency use authorization (EUA) for the administration of a third dose (or booster) of the Pfizer-BioNTech and Moderna vaccines in certain immunocompromised adults.
About 201.4 million Americans (60.7%) have received at least one dose of a COVID-19 vaccine, and 170.8 million (51.5%) are fully vaccinated, according to data as of Aug. 22 from the Centers for Disease Control and Prevention (CDC).
After peaking in April, COVID-19 vaccination rates have steadily fallen, though the numbers have recently been increasing amid rising cases, hospitalizations and deaths. The White House announced Thursday that for the first time in weeks, more than 1 million doses had been administered in the past 24 hours.
Woodcock said she hoped today’s announcement will spur even more vaccinations.
“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,” she said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The news may help convince the hesitant or undecided to get vaccinated. As much as 31% of unvaccinated adults said they would be more likely to get a vaccine if one approved for emergency use authorization was granted full approval, according to a June Kaiser Family Foundation COVID-19 Vaccine Monitor survey.
However, the real driver of future vaccinations will likely be because of mandates. In recent weeks, K-12 schools, universities, federal agencies, state offices and private companies have started announcing requirements for proof of vaccination or regular COVID-19 testing, mask wearing and social distancing to help combat the delta variant.
Legally, employers and schools have the right to mandate vaccinations. Still, the EUA status of the COVID-19 vaccinations ensured there would at least be some pushback in the courts. Indeed, there has and with mixed rulings.
This FDA approval clears the way for more mandates—and perhaps more importantly—the enforcement of those mandates.
Comirnaty was first granted EUA on Dec. 11, 2020, for those 16 and up. The authorization has been reissued since and was expanded to include those aged 12 to 15 on May 10, 2021.
Today’s announcement was based on the full data required for a biologics license application, which included updated data from the clinical trial that supported the EUA and included a longer duration of follow-up in a larger clinical trial population, according to the FDA. It also included data from about 44,000 people aged 16 and up. More than half of those participants were followed for safety outcomes for at least four months after the second dose, and about 12,000 recipients were followed for at least six months.
Comirnaty was found to be 91% effective in preventing COVID-19 disease based on results from the clinical trial.
The FDA and CDC will continue monitoring to ensure any safety concerns continue to be identified and evaluated in a timely manner.
Regulators are still reviewing Moderna’s application for full approval of its vaccine, The New York Times reports. That decision could take several weeks. Johnson & Johnson/Janssen is expected to apply soon for full approval.
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