On Monday, Aug. 23, the United States Food and Drug Administration approved the first COVID-19 vaccine, according to a press release from the organization.
The FDA granted Pfizer and BioNTech full U.S. approval of their vaccine, allowing the company to become the first in the U.S. to win the designation and giving even more institutions greater confidence to adopt vaccine mandates.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said acting FDA Commissioner Janet Woodcock, M.D. in the press release. “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.”
The Pfizer vaccine is currently available to individuals 16 years of age and older. The vaccine is also available under Emergency Use Authorization for individuals ages 12 through 15 and for the administration of a third dose in certain immunocompromised individuals, according to the press release.
As part of the FDA's approval, the agency analyzed data from 40,000 trial participants, according to the U.S. agency. The vaccine was found to be 91% effective in preventing COVID-19. The numbers are slightly lower than the 95% efficacy rate trial data showed when the shot was authorized last year and before the delta variant took hold in the U.S.
As of Aug. 16, 168 million people in the U.S. have been fully vaccinated, according to the Centers for Disease Control and Prevention.
For more information on the FDA's approval, click here.