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Yes, FDA-approved Comirnaty has the same formula as the Pfizer-BioNTech vaccine used under Emergency Use Authorization

Comirnaty is a COVID-19 vaccine for people 16 years of age and older. It is the first COVID-19 vaccine to be granted full approval by the FDA.

AUSTIN, Texas —

The Question

Is the FDA-approved Pfizer vaccine, Comirnaty, the same as what’s been available?

The Answer

Yes, the FDA-approved Pfizer-BioNTech vaccine, Comirnaty, is the same vaccine Pfizer-BioNTech COVID-19 vaccine administered under Emergency Use Authorization.

The Sources

Pfizer, Inc.

U.S. Food and Drug Administration

What we found

Comirnaty is approved by the FDA for those 16 and older.

The FDA allows people 12 to 15 years of age to get the Pfizer-BioNTech vaccine under Emergency Use Authorization (EUA).

“The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series,” Pfizer’s website shows. 

The FDA writes, “The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccine.”

While the FDA-approved Comirnaty and the FDA-authorized Pfizer-BioNTech COVID-19 vaccine are the same, the approval for Comirnaty is for those 16 years and older while the authorized vaccine is for those 12 years and older.

“The companies also intend to submit a supplemental BLA [Biologics License Application] to support potential full FDA approval of COMIRNATY in individuals 12 through 15 years of age once the required data out to six months after the second vaccine dose are available. In the meantime, the vaccine remains available to 12- to 15-year-olds under the Emergency Use Authorization (EUA) granted by the FDA on May 10, 2021," Pfizer's website shows.

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