US regulators approved Pfizer-BioNTech shot under new name
Articles and social media posts shared thousands of times claim that the US Food and Drug Administration (FDA) did not give full approval to the Covid-19 vaccine from Pfizer-BioNTech. This is false; the agency signed off on the shot for Americans aged 16 and older on August 23, 2021.
"FDA 'playing bait and switch' with Americans, tricking them into believing shots currently being offered have been granted full approval when they have not," says the headline of an August 25, 2021 article on the LeoHohmann.com website.
"What was actually given full approval was a separate Pfizer-BioNTech vaccine product which goes by the name Comirnaty," the article says.
A Facebook post also claimed that the FDA "'REISSUED' The 'Emergency Use Authorization' (EUA)" instead of approving the vaccine.
Similar claims appeared in an article here and on Facebook here.
Comirnaty vs Pfizer
Comirnaty is the new name under which Pfizer-BioNTech's FDA-approved Covid-19 vaccine will be marketed.
Dr Janet Woodcock, the FDA's Acting Commissioner of Food and Drugs, explained in a media call that Comirnaty and the Pfizer shot are the same.
"The FDA-approved vaccine and the EUA-authorized vaccine have the same formulation and can be used interchangeably," she said on August 23.
Approval vs EUA
While Comirnaty is fully approved in the United States for those 16 and older, "the vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals," an August 23 FDA press release says.
While the shots are the same, FDA spokeswoman Veronika Pfaeffle clarified that the EUA will continue to cover the Pfizer-BioNTech-branded vaccines until a sufficient supply with the new Comirnaty name can be manufactured and distributed.
AFP Fact Check has debunked other inaccurate claims about vaccines here.