The Pfizer/BioNTech COVID-19 vaccine will be marketed with the name Comirnaty. ROBYN BECK/AFP via Getty Images
  • The United States reaches another pandemic milestone, with a COVID-19 vaccine fully approved by the Food and Drug Administration.
  • The full approval is for use of the two-dose vaccine to prevent COVID-19 in people 16 years and older.
  • However, children younger than 12 years old still do not have access to a vaccine yet.

The Food and Drug Administration (FDA) granted full approval to Pfizer-BioNTech’s COVID-19 vaccine, making it the first vaccine of its kind to reach this regulatory milestone in the United States.

This replaces the emergency use authorization (EUA) that the agency issued last December.

The full approval is for use of the two-dose vaccine to prevent COVID-19 in people 16 years and older. The vaccine will be marketed with the brand name Comirnaty.

The vaccine is still available for 12- to 15-year-olds and as a third dose for certain people with weakened immune systems through the existing emergency approval.

“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,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.

Full approval may boost vaccination rates

For the millions of Americans who have already received the Pfizer-BioNTech vaccine under the EUA, the FDA’s full approval doesn’t change much.

But experts hope that full approval will nudge some people who are hesitant to roll up their sleeves.

According to a June poll by the Kaiser Family Foundation, 31 percent of unvaccinated adults said they would be more likely to get a COVID-19 vaccine if it received full approval from the FDA.

“In my clinic, I had patients express they wanted to wait until full FDA approval before getting vaccinated, and I am sure this is the case for many across the nation,” Dr. Natasha Bhuyan, a family physician in Phoenix, told Healthline.

“With this approval, we will hopefully see a further boost in vaccinations, especially in areas where vaccination rates are low, and finally, get communities across the nation closer to reaching herd immunity.”

It’s not clear how much of an impact the FDA’s approval might have on the vaccine-hesitant because there is already much confusion about the vaccine approval process.

Most people surveyed in June by KFF — unvaccinated and vaccinated — incorrectly thought the vaccines already had full approval or weren’t sure of the vaccines’ regulatory status.

Bhuyan said full approval of the Pfizer-BioNTech vaccine might even “lead to more vaccine mandates in places like schools, work, government agencies, travel or even potentially places we go to for entertainment or dining.”

Full approval would also allow licensed physicians to prescribe the vaccine “off-label” — such as recommending that people get an additional dose of this vaccine before the FDA approves booster doses, likely in September.

This approval still does not mean children under age 12 are likely to get access to the vaccine just yet.

Woodcock said in a news conference on August 23 that she hopes physicians would not prescribe the Pfizer-BioNTech vaccine to children under age 12.

The clinical studies to determine the safety of the vaccine and the best dose for younger children are ongoing, and data is expected to be released this fall.

FDA reviews longer-term safety data

The FDA’s emergency approval process is intended to make medical treatments available sooner during public health emergencies such as a pandemic.

The Pfizer-BioNTech EUA application was based on an average of 2 months follow-up — after the second dose — of over 30,000 participants in the vaccine trial.

During its full review, the FDA examined at least 4 months of follow-up safety data, which was available on more than half of the trial participants, the agency said in its release.

Around 12,000 participants have been followed for at least 6 months after their second dose.

The most commonly reported side effects were similar to those reported in the EUA application — injection site pain, redness or swelling, fatigue, headache, joint or muscle pain, chills and fever.

The FDA also noted a higher risk of heart inflammation — myocarditis or pericarditis — after vaccination.

This condition is more common within 7 days after the second dose and among males under age 40.

However, most people improved with relatively minor treatment such as anti-inflammatory medication.

In June, the FDA added a warning to recipient and provider fact sheets for the Pfizer-BioNTech — and also the Moderna-NIAID — COVID-19 vaccines about this risk.

The longer-term follow-up puts the Pfizer-BioNTech vaccine on par with other vaccines marketed in the United States.

“The full approval may help people understand that this vaccine is safe for them, their friends and their family to receive,” said Bhuyan.

Moderna announced in June that it initiated rolling submission of the application for full FDA approval of its COVID-19 vaccine. The FDA has not indicated when it will finish its review of this application.

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