On Aug. 23, the Pfizer-BioNTech vaccine became the first COVID-19 vaccine to receive full approval from the U.S. Food and Drug Administration (FDA). Before approval was granted, the Pfizer vaccine had been authorized for emergency use (EUA) in the United States by the FDA since Dec. 11, 2020.
When approval was announced, the FDA and Pfizer-BioNTech said the vaccine would now be marketed under the name Comirnaty in the U.S. A VERIFY viewer wants to know if the FDA-approved Comirnaty and the EUA Pfizer COVID-19 vaccine contain the same ingredients.
Are Comirnaty and the Pfizer COVID-19 vaccine the same?
Yes, Comirnaty and the Pfizer COVID-19 vaccine are the same.
WHAT WE FOUND
On Dec. 21, 2020, Pfizer and BioNTech’s vaccine became the first COVID-19 vaccine to receive a conditional marketing authorization from the European Commission. The European Medicines Agency said that the vaccine would be marketed under the name Comirnaty.
In a joint press release, Pfizer and BioNTech said they decided on the name Comirnaty because it “represents a combination of the terms COVID-19, mRNA, community, and immunity, to highlight the first authorization of a messenger RNA (mRNA) vaccine, as well as the joint global efforts that made this achievement possible with unprecedented rigor and efficiency – and with safety at the forefront – during this global pandemic.”
A company called the Brand Institute, which is an agency that specializes in the development of brand names and identities, worked with Pfizer and BioNTech to come up with the name of the vaccine.
“The entire staff at Brand Institute and Drug Safety Institute is honored to have partnered with two incredible companies, Pfizer and BioNTech, on the development of their COVID-19 vaccine’s brand name, COMIRNATY®,” said Brand Institute’s Chairman and CEO, James L. Dettore in December. “Naming a product that will have such a profound impact on humanity is humbling, and an opportunity for which we are truly grateful.”
According to the FDA, Comirnaty has the same formulation as the Pfizer COVID-19 vaccine that was previously authorized for emergency use (EUA) in the United States. It will continue to be administered as a series of two doses, three weeks apart, for the prevention of COVID-19 disease in individuals 16 years of age and older.
“Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19,” said the FDA. When the Pfizer COVID-19 first received its EUA in December 2020, the FDA used a similar description to describe the vaccine’s properties.
A Pfizer spokesperson also told VERIFY by email that Comirnaty and the EUA Pfizer-BioNTech COVID-19 vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series, according to FDA labeling.
“In terms of its ingredients and how it is made, the FDA-approved vaccine for those 16 years and older is no different from the vaccine that has been administered, to date, to millions around the world under the EUA,” said Pfizer.
For more information on Comirnaty, visit the FDA’s website.
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