What full FDA approval of Pfizer's COVID-19 vaccine would mean

Pfizer-BioNTech vaccine
(Image credit: Michael Ciaglo/Getty Images)

The COVID-19 vaccine from Pfizer and BioNTech could become the first in the United States to receive full FDA approval.

The companies announced Friday they have initiated an application seeking full approval of the vaccine for people 16 and over from the Food and Drug Administration, CNN reports. The vaccine is now being administered under an emergency use authorization, a "mechanism to facilitate the availability and use of" vaccines "during public health emergencies," per the FDA.

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With that in mind, experts have said full FDA approval could help reduce vaccine hesitancy and further demonstrate that the vaccines are safe. Former U.S. Surgeon General Jerome Adams wrote in The Washington Post that "many people who are lower risk" have expressed uncertainty over whether the "benefits justify taking a medication that has not received the full and traditional FDA stamp of approval." So full approval might provide a "boost of confidence to people who were on the fence about getting vaccinated," Brown University School of Public Health dean Ashish Jha said.

If the vaccine is fully approved, Pfizer can also start marketing and distributing it. Another key difference, CNN writes, is that full approval could "have an impact on vaccine mandates," as "some organizations say they expect to require the vaccine, but have opted not to while it's authorized and not yet fully approved." ABC News reports it's likely to take "several months" for the FDA to make a decision.

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Brendan Morrow

Brendan worked as a culture writer at The Week from 2018 to 2023, covering the entertainment industry, including film reviews, television recaps, awards season, the box office, major movie franchises and Hollywood gossip. He has written about film and television for outlets including Bloody Disgusting, Showbiz Cheat Sheet, Heavy and The Celebrity Cafe.