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Pfizer vaccine approved in US, marketed as Comirnaty

September 1, 2021 GMT

CLAIM: There is currently no FDA-approved vial of COVID-19 vaccine available in the U.S.

AP’S ASSESSMENT: False. The Pfizer vaccine, which is now marketed as Comirnaty, is approved by the U.S. Food and Drug Administration for use by those 16 and over and is available in the U.S.

THE FACTS: Following the U.S. Food and Drug administration’s full approval of Pfizer’s COVID-19 vaccine last week for those 16 and over, posts online are misrepresenting the announcement to falsely claim the vaccine still lacks formal approval.

One Instagram post acknowledged the Comirnaty vaccine had received FDA approval, but made the false claim that the only available doses are Pfizer vials that are still just under emergency use authorization.

In fact, Comirnaty is the new brand name Pfizer is using to market its COVID-19 vaccine and there is no distinction between the two.

In December, the FDA granted Pfizer’s vaccine emergency use authorization based on a study of 44,000 people 16 and older who were followed for two months. During public health emergencies, the FDA can issue emergency use authorizations for products that prevent, treat or diagnose a disease.

After Pfizer submitted six months of follow up safety data, the FDA granted full approval for those 16 and older to use the vaccine, now marketed as Comirnaty.

The formulation used in the FDA-approved Comirnaty vaccine is identical to the shot that previously received emergency use authorization.

“It’s the same vaccine,” Dr. Joshua Sharfstein, vice dean for public health practice and community engagement at Johns Hopkins University and former FDA deputy commissioner,told the AP.“There is only one vaccine.”

Sharfstein said since some people were waiting for the FDA to grant full approval, last week’s announcement should encourage more vaccinations. “All the good reasons to get vaccinated are still there and have not changed,” he said.

Pfizer was already using the Comirnaty name on its vaccine vials and packaging before the vaccine received full approval for people 16 and older on August 23. Pfizer announced in December that it was marketing the vaccine in the European Union under that brand name

A Pfizer news release at the time said the name Comirnaty, “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.”

Pfizer’s COVID-19 vaccines remain under emergency use authorization for teenagers ages 12 through 15, and for immunocompromised individuals receiving a third dose, until Pfizer submits its application and safety data for those groups.

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This is part of AP’s effort to address widely shared misinformation, including work with outside companies and organizations to add factual context to misleading content that is circulating online. Learn more about fact-checking at AP.