the coronavirus crisis
The Food and Drug Administration has for the first time granted full approval to a COVID-19 vaccine.
The FDA announced Monday it has fully approved the COVID-19 vaccine from Pfizer-BioNTech, which had previously been authorized for emergency use, for those 16 or older. Earning full approval from the FDA required additional data, and experts are hopeful this could encourage more people to get the shot.
"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," acting FDA Commissioner Janet Woodcock said. "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."
The approval comes amid the spread of the more contagious Delta variant of COVID-19 and as U.S. health officials prepare to start administering booster shots to all Americans. As for whether the full FDA approval will result in an uptick in vaccinations, former FDA chief scientist Jesse Goodman predicted to The Washington Post it "will provide an additional nudge but not make a huge difference." But Heidi J. Larson, director of the Vaccine Confidence Project, told the Post, "It's a great thing that it's finally getting its approval. It will be an important confidence-builder."
Surgeon General Vivek Murthy also previously told CNN that full approval from the FDA could prompt more businesses and universities to start "putting vaccine requirements in place in order to create safer spaces for people to work and learn."