Pfizer phone message about vaccine approval misrepresented

CLAIM: Pfizer acknowledges on its own information line that its COVID-19 vaccine has not been fully approved or licensed by the U.S. Food and Drug Administration. 

AP’S ASSESSMENT: Missing context. Pfizer and BioNTech have received an emergency use authorization for their vaccine from the FDA but they still await full vaccine licensure, which is expected to occur later this year. 

THE FACTS: A video circulating on Twitter is being held up as proof that Pfizer vaccine has not been fully approved for use.

In the video, a voice message from a Pfizer information line plays on a cellphone. The recording says “the Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. FDA but has been authorized for emergency use to prevent COVID-19 in individuals 16 and over.”

“What Pfizer isn’t telling you!,” one tweet with the video said, receiving more than 2,000 likes and 60,000 views.

An Instagram post with more than 2,000 likes sharing the video also said: “For those assuming safety has been established or that all protocols have been meet.” 

While the recording is authentic, the video lacks context on how emergency authorization works. 

The FDA can give emergency authorization for medical products to address a public health crisis, in this case the pandemic, as long as the benefits outweigh the risks. In order to receive an approval for emergency use, vaccine manufacturers have been required to conduct clinical trials on tens of thousands of people, submitting follow-up data for review.  

“An authorization is a determination by the FDA in this case that the vaccine is safe and effective to be used,” Dr. Joshua Sharfstein, vice dean for public health practice and community engagement at Johns Hopkins University. “It’s not the case that the FDA thinks the vaccine is unsafe, that would be untrue.”

Along with receiving emergency use authorization, the Pfizer vaccine is expected to receive full licensure approval from the FDA when the company submits six months of safety follow-ups, which could happen as soon as the spring or summer. 

“I would fully expect the vaccine to be licensed,” Sharfstein said. 

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This is part of The Associated Press’ ongoing effort to fact-check misinformation that is shared widely online, including work with Facebook to identify and reduce the circulation of false stories on the platform.

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