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FDA Approves Pfizer-BioNTech COVID-19 Vaccine

The milestone marks the first fully-approved COVID-19 vaccine in the United States.

Written byAnnie Melchor
| 3 min read
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Update (January 31, 2022): The FDA has now granted full approval to Moderna's COVID-19 vaccine as well.

Update (October 29): The US Food and Drug Administration has granted an emergency use authorization for the use of Pfizer-BioNTech's COVID-19 vaccine in children aged 5 to 11 years, NPR and other outlets report.

Today (August 23), the United States Food and Drug Administration announced the approval of the Pfizer-BioNTech COVID-19 vaccine, making it the first fully approved COVID-19 vaccine in the country, according to a statement from the federal agency. The vaccine is now fully approved for use in individuals ages 16 and older—but remains in the emergency use authorization (EUA) stage for children ages 12 to 15, as well as in the context of third doses for immunocompromised persons.

Since December 11, 2020 the Pfizer-BioNTech vaccine has been in use in the US under EUA, a designation ...

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Meet the Author

  • black and white photograph of stephanie melchor

    Stephanie "Annie" Melchor got her PhD from the University of Virginia in 2020, studying how the immune response to the parasite Toxoplasma gondii leads to muscle wasting and tissue scarring in mice. While she is still an ardent immunology fangirl, she left the bench to become a science writer and received her master’s degree in science communication from the University of California, Santa Cruz, in 2021. You can check out more of her work here.

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