The Food and Drug Administration has approved Pfizer’s COVID-19 vaccine — making it the first COVID-19 vaccine subject to a full review by the U.S. regulator and to receive formal approval.
The vaccine has been approved for the prevention of COVID-19 disease in individuals 16 years of age and older.
“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 a statement released on Monday.
The FDA says scientists assessed “hundreds of thousands of pages” of vaccine data from 40,000 trial participants. The vaccine was found to be 91% effective in preventing Covid.
“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.”
Children between ages 12 and 15 can still receive the jab under the current emergency use authorization.
More than 60% of the total U.S. population has had at least one dose of a Covid vaccine. Still, many Americans still remain reluctant about the possible side effects of the vaccine. The FDA’s stamp of approval could help to boost confidence in the jab.