Not Real News

Stories circulating online incorrectly assert that there currently is no Food and Drug Administration-approved vial of COVID-19 vaccine available in the U.S. But, 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.

CLAIM: There currently is no Food and Drug Administration-approved vial of COVID-19 vaccine available in the U.S.

THE FACTS: After the FDA’s full approval of Pfizer’s COVID-19 vaccine last month for those 16 and older, posts online are misrepresenting the announcement to falsely claim that the vaccine still lacks formal approval.

One Instagram post acknowledged that the Comirnaty vaccine had received FDA approval, but made the false claim that the only available doses are Pfizer vials that still are just under emergency use authorization. In fact, Comirnaty is the 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 a former FDA deputy commissioner, told The Associated Press. “There is only one vaccine.”

Sharfstein said that since some people were waiting for the FDA to grant full approval, last month’s announcement should encourage more vaccinations. Pfizer already was using the Comirnaty name on its vaccine vials and packaging before the vaccine received full approval for people 16 and older Aug. 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 that 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 12 through 15, and for immunocompromised individuals receiving a third dose, until Pfizer submits its application and safety data for those groups.