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Ciara O'Rourke
By Ciara O'Rourke October 14, 2021

No, Pfizer didn't admit that its vaccine isn’t FDA-approved

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  • Pfizer has received FDA approval for its COVID-19 vaccine for people 16 and older. 

A recent blog post headline says that President Joe Biden is "busted." Why? Because, as the headline continues, "Pfizer admits there’s no vaccine approved by FDA in the U.S." 

"Joe Biden and his regime have stated that Pfizer’s COVID vaccine has FDA approval," the Oct. 10 post says. "Someone recently recorded a call of Pfizer saying something completely different." 

A video of what appears to be a recording of a call with someone at the "Pfizer customer response center" is embedded in the post. During the purported call, a person tells the caller that Pfizer’s COVID-19 vaccine hasn’t been approved by the Food and Drug Administration and that it’s only received the FDA’s emergency use authorization. 

We don’t know if the recording is authentic, and if it is, when it took place. Pfizer did not respond to our questions about it. But we do know that the vaccine has been approved by the FDA. 

This post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.)

Pfizer’s COVID-19 vaccine received FDA approval for people 16 and older on Aug. 23

Before that, the vaccine was authorized for this group under an emergency use authorization. And the vaccine is still only available for 12-15 year olds under emergency use authorization because it hasn’t yet been approved by the FDA for people between those ages. 

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"I can confirm that our vaccine has been granted FDA approval," Pfizer spokesperson Keanna Ghazvini told PolitiFact on Oct. 13. 

She pointed us to two press releases, one from Pfizer on Aug. 23 announcing that the company had received "full U.S. FDA approval for individuals 16 years and older," and one from the FDA the same day that said it had approved the first COVID-19 vaccine. 


During public health emergencies, the FDA has the power to grant emergency use authorization to products that meet specific criteria when there’s no adequate, approved and available alternative to treat a disease — in this case, COVID-19. 

When COVID-19 was declared a pandemic in early 2020, there weren’t any approved vaccines for it, so the FDA granted emergency use authorization in December 2020 to the Pfizer and Moderna vaccines, and in February 2021 to the Johnson & Johnson vaccine. All three were evaluated for their safety and efficacy before being authorized.

The Moderna and Johnson & Johnson vaccines have not yet received FDA approval and remain under the emergency use authorization. 

The recording in the blog post is described as a Pfizer customer service representative saying that the vaccine hasn’t been approved. If she said that after Aug. 23 about the 16-and-up group, she was wrong. But in any case, that doesn’t amount to the company admitting that the vaccine didn’t receive FDA approval. It did, and Pfizer is on record proudly saying so. 

We rate this post False.


Our Sources

Blog post, Oct. 10, 2021

PolitiFact, What’s in a name? Louisiana lawmakers wrongly say name change scuttles FDA COVID-19 vaccine approval, Oct. 7, 2021

PolitiFact, Yes, Pfizer’s COVID-19 vaccine is FDA approved, Sept. 17, 2021

U.S. Food and Drug Administration, FDA approves first COVID-19 vaccine, Aug. 23, 2021

Pfizer, Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full U.S. FDA approval for individuals 16 years and older, Aug. 23, 2021

U.S. Food and Drug Administration, Vaccine information fact sheet for recipients and caregivers about Comirnaty, visited Oct. 14, 2021

Centers for Disease Control and Prevention, Pfizer BioNTech COVID-19 vaccine overview and safety, updated Sept. 28, 2021 

Email interview with Keanna Ghazvini, senior associate, global media relations, Pfizer, Oct. 13, 2021

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No, Pfizer didn't admit that its vaccine isn’t FDA-approved

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