FDA grants full approval for Pfizer-BioNTech coronavirus vaccine

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This could open up more opportunities for vaccine mandates.

Pfizer-BioNTech's COVID-19 vaccine.
(Image credit: Shutterstock)

The Food and Drug Administration (FDA) granted full approval to Pfizer-BioNTech's coronavirus vaccine on Monday (Aug.23). 

That marks the first full approval for a COVID-19 vaccine in the U.S., and might pave the way for more vaccine mandates and ease concerns of those who are unvaccinated. 

Related: Coronavirus variants: Here's how the SARS-CoV-2 mutants stack up 

Pfizer-BioNTech was the first COVID-19 vaccine to be granted an emergency use authorization in December 2020. Under the emergency approval, more than 92 million people in the U.S. have been fully vaccinated with the Pfizer-BioNTech vaccine, according to the Centers for Disease Control and Prevention (CDC). 

To meet full approval, the companies have to submit a "biologics license application"  that includes at least 6 months of post-vaccination followup on clinical trial participants, more details of the manufacturing process, vaccine manufacturing site inspections and quality tests of samples of the vaccine. 

"We evaluated scientific data and information included in hundreds of thousands of pages," conducted their own safety and effectiveness analysis and performed a detailed assessment of manufacturing facilities, Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a statement on Monday.

"The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," Dr. Janet Woodcock, acting commissioner of the FDA, said in the statement."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."

What's more, full approval could lead to more vaccination mandates, as many businesses were waiting for full approval before requiring their employees to be vaccinated, according to NBC News.

The full approval for Pfizer-BioNTech includes people 16 years of age or older, but children ages 12 to 15 can still receive the vaccine under emergency authorization. Moderna has also applied for full approval, but Johnson & Johnson has not yet applied (both have emergency use authorizations), according to NBC News.

The Pfizer-BioNTech vaccine will now be marketed as Comirnaty.

Originally published on Live Science.

Yasemin Saplakoglu
Yasemin Saplakoglu
Staff Writer

Yasemin is a staff writer at Live Science, covering health, neuroscience and biology. Her work has appeared in Scientific American, Science and the San Jose Mercury News. She has a bachelor's degree in biomedical engineering from the University of Connecticut and a graduate certificate in science communication from the University of California, Santa Cruz.