FDA Grants Pfizer Vaccine Full Approval

The Food and Drug Administration (FDA) announced Monday that it has granted full approval to the COVID-19 vaccine developed by Pfizer and BioNTech for individuals 16 years of age or older.

The vaccine approval is the fastest in the agency’s history, coming less than four months after Pfizer-BioNTech completed its “biologics license application” in May. The FDA had moved to clear the shot’s regulatory hurdles in record time, evaluating the company’s latest safety data and inspecting vaccine factories around the world, according to CBS News.

“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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” FDA Acting Commissioner Janet Woodcock said in a statement.

The Pfizer-BioNTech vaccine has been available since December 2020 under an Emergency Use Authorization, which regulators expanded in May to include children 12 years of age or older. The FDA earlier in August approved a third booster shot of the vaccine immunocompromised people.