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.
— U.S. FDA (@US_FDA) August 23, 2021
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.
More than 204 million doses of the Pfizer-BioNTech vaccine have been administered and at least 92 million Americans are fully vaccinated with both vaccine doses, according to the Centers for Disease Control and Prevention (CDC). Multiple studies have also found the vaccine to be highly effective at preventing severe COVID-19 infections, hospitalization and death for most people. (RELATED: What Will It Take To Get Back To Normal? Here’s What The Experts Say)
Regulators had also faced growing pressure to grant full approval to the Pfizer-BioNTech vaccine due to the highly contagious Delta variant of the virus, according to CBS News. CDC director Rochelle Walensky estimated in late July that the variant made up around 83% of new cases.
Public health experts said the FDA’s decision to grant full approval could create an incentive for more people to get vaccinated, according to The Washington Post. But the move could also pave the way for more employers to introduce vaccine requirements.
New York City became the first major city in the U.S. to announce a vaccine requirement for residents to participate in most indoor activities. A growing number of employers, including the federal government, have also announced they will be requiring their workers to get vaccinated.