What It Takes To Get a Vaccine FDA Approved

The Pfizer-BioNTech COVID-19 vaccine is the agency’s fastest approval ever — here’s how it was accomplished without shortchanging safety standards.

By Marisa Sloan
Oct 1, 2021 1:00 PMOct 1, 2021 1:01 PM
Pfizer-BioNTech vaccine
(Credit: cortex-film/Shutterstock)

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For the Pfizer-BioNTech COVID-19 vaccine — now marketed as Comirnaty full approval by the Food and Drug Administration last month required going through the agency’s standard review process before being determined safe and effective at preventing the coronavirus. This occurred roughly eight months after the FDA had approved the vaccine for emergency use.

“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,” acting FDA Commissioner Janet Woodcock said in a statement.

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