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A health care worker fills a syringe with the Pfizer COVID-19 vaccine. July 22, 2021 (AP) A health care worker fills a syringe with the Pfizer COVID-19 vaccine. July 22, 2021 (AP)

A health care worker fills a syringe with the Pfizer COVID-19 vaccine. July 22, 2021 (AP)

Tom Kertscher
By Tom Kertscher September 17, 2021

Yes, Pfizer’s COVID-19 vaccine is FDA approved

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  • The Pfizer vaccine had been administered under an emergency use authorization from the U.S. Food and Drug Administration. On Aug. 23, the vaccine received FDA approval.

Even after the U.S. Food and Drug Administration gave its approval to the Pfizer COVID-19 vaccine — the first vaccine to get such approval — posters on TikTok were still suggesting it was some kind of rogue jab.

One video started with a woman stating: "You guys, the Pfizer vaccine is not approved. They’ve been saying it’s been approved. I have proof, straight from the website where you sign up to get your vaccine, it is not approved for anything beyond the emergency use approval." 

TikTok identified videos with this message as part of its efforts to counter inauthentic, misleading or false content. (Read more about PolitiFact's partnership with TikTok.)

Similar claims have been made elsewhere on TikTok. Text with another video states: "The Pfizer vaccine is not an approved FDA vaccine it's only approved for emergency use for a third dose." 

The claim that the Pfizer vaccine is not approved is wrong.

During public health emergencies, the FDA has the legal power to grant emergency use authorization to certain products if they meet specific criteria and when there’s no adequate, approved and available alternative to treat the malady. That’s what happened when COVID-19 was declared a pandemic in early 2020 and there weren’t any approved vaccines for it.

The FDA granted emergency use authorization to the Pfizer and Moderna vaccines in December 2020 and to the Johnson & Johnson vaccine in February 2021.

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FDA approval, meanwhile, depends on more substantial evidence that the product is effective and that its benefits outweigh its risks.

In a news release on Aug. 23 that was headlined, "FDA Approves First COVID-19 Vaccine," the FDA announced its approval of the Pfizer vaccine to people age 16 and over. 

Perhaps adding to the confusion, the FDA announcement noted that Pfizer would now market the vaccine under the name Comirnaty. It also noted that the vaccine is still covered only by the emergency use authorization for people ages 12 to 15 and for the administration of a third dose in certain immunocompromised individuals.

But there is no question that the Pfizer vaccine has received FDA’s approval.

While the Pfizer vaccine "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," the FDA announcement said. 

"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated."

Moderna announced on Aug. 25 that it has completed its application for  approval. Johnson & Johnson is expected to apply sometime in 2021.

We rate the TikTok posts False.

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Yes, Pfizer’s COVID-19 vaccine is FDA approved

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