The US Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates.

The vaccine will be marketed as Comirnaty, the FDA said in its announcement on Monday. The Pfizer/BioNTech vaccine has been authorized for emergency use in the United States since mid-December for people age 16 and older, and in May, the authorization was extended to those 12 and older.
“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” according to the FDA.
Out of more than 170 million people in the United States fully vaccinated against Covid-19, more than 92 million have received the Pfizer/BioNTech vaccine.
“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 confident that this vaccine meets the FDA’s gold standard for safety, effectiveness and manufacturing quality that we require for an approved product,” FDA Acting Commissioner Dr. Janet Woodcock said during a briefing on Monday, calling the approval “a pivotal moment” for the United States’ fight against the coronavirus pandemic.

“Health care providers can continue to use the vaccine on their shelves,” Woodcock added. “The FDA-approved vaccine and the EUA-authorized vaccine have the same formulation and can be used interchangeably to provide the Covid-19 vaccine series.”

Agency official said Monday they hope approval will push unvaccinated people to get vaccinated. US Surgeon General Dr. Vivek Murthy said on CNN’s State of the Union on Sunday that approval could encourage individuals to act, and more mandates.

“For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” Murthy told CNN’s Brianna Keilar.

Murthy also noted “a small number of people” have been waiting for full approval before getting their shot and believes “this may tip them over toward getting vaccinated.”
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