Fact check: Pfizer's FDA-approved vaccine is available in US

·4 min read

The claim: Pfizer's FDA-approved coronavirus vaccine is not yet available in the United States

The Biden administration has released a plan aimed at vaccinating 28 million children against COVID-19. An independent Food and Drug Administration advisory committee will meet in late October to consider authorizing the Pfizer-BioNTech shot for those ages 5 to 11.

On social media, however, some say an FDA-approved COVID-19 vaccine is still not available for American adults.

"I wonder how many of these employers firing their employees for failure to take the (vaccine), realize all (vaccines) are still under 'Emergency Use Authorization' and have not been given full FDA authorization," reads an Oct. 20 text post on Facebook. "Comirnaty is NOT available in US yet!"

Comirnaty is the brand name for Pfizer's coronavirus vaccine. The FDA approved the shot in late August for Americans ages 16 and older.

But posts claiming Comirnaty is not yet available in the U.S. have racked up thousands of interactions on Facebook and Instagram over the past month, according to CrowdTangle, a social media insights tool. Politicians such as Sen. Ron Johnson, R-Wis., and conservative pundits including Joe Pagliarulo have aired similar claims.

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USA TODAY has debunked the notion that the Pfizer vaccine is not FDA-approved. That claim is similarly wrong.

"I can confirm that our vaccine has been granted FDA approval and that Comirnaty is available," Kit Longley, a spokesperson for Pfizer, said in an email.

USA TODAY reached out to the Facebook user who shared the claim for comment.

Pfizer vaccine available in US

The FDA authorized Pfizer's coronavirus vaccine for emergency use in December. Eight months later, the agency fully approved the shot for most Americans.

The authorization changed, but the vaccine didn't. Comirnaty is simply the brand name for Pfizer's shot.

"The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty ... for the prevention of COVID-19 disease in individuals 16 years of age and older," the FDA wrote in an Aug. 23 press release about the shot's approval.

Christoffer Knight prepares a dose of the Pfizer COVID-19 vaccine during "Play date to vaccinate" for pregnant women at Palm Beach Children's Hospital in West Palm Beach, Fla.
Christoffer Knight prepares a dose of the Pfizer COVID-19 vaccine during "Play date to vaccinate" for pregnant women at Palm Beach Children's Hospital in West Palm Beach, Fla.

Once the FDA approves vaccines, companies are permitted to market them under brand names, according to Scott Pauley, a press officer for the Centers for Disease Control and Prevention. Manufacturers may also then advertise their shots.

Because hundreds of millions of Pfizer doses were manufactured before the FDA's full approval, some vials administered now may not have a Comirnaty label. But that doesn't change what's in the shot.

"There has been no change in the formulation of the vaccine since the name change," Pauley told USA TODAY in an email.

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As of Oct. 20, more than 104 million Americans had received two doses of Pfizer's coronavirus vaccine, according to CDC data. Other independent fact-checking organizations have debunked the claim that the FDA-approved shot isn't available in the U.S.

Our rating: False

Based on our research, we rate FALSE the claim that Pfizer's FDA-approved coronavirus vaccine is not yet available in the U.S. The agency approved the vaccine for most Americans in August, and more than 104 million people have received two doses. The formulation of Pfizer's shot did not change when it was renamed Comirnaty following full FDA approval.

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Our fact-check work is supported in part by a grant from Facebook.

This article originally appeared on USA TODAY: Fact check: Comirnaty, Pfizer's FDA-approved vaccine, available in US

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