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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 has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older,” 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. In May, the authorization was extended to those 12 and older.,49034001.html


“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.

This weekend, officials familiar with the decision said they discussed how to prepare for the rollout once the FDA grants full approval, given it will be a major messaging opportunity to encourage vaccination.

US Surgeon General Dr. Vivek Murthy said on CNN’s State of the Union on Sunday that approval could encourage more people to get vaccinated, 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.”

Why emergency use authorization came first
Due to the seriousness of the pandemic, vaccine makers originally applied for emergency use authorizations because the authorization process takes less time than what’s required for full approval.

In July, drugmaker Pfizer announced that the FDA granted its vaccine a priority review, and the FDA had been pulling in extra help from across the agency to speed final approval of the vaccine, an agency spokeswoman told CNN in late July.

FDA approval of the Covid-19 vaccine could mean more people will get vaccinated for an unexpected reason
FDA approval of the Covid-19 vaccine could mean more people will get vaccinated for an unexpected reason
Emergency use authorization is what its name suggests — a medical product, such as a vaccine, that gets special FDA authorization to be used during an emergency. When the health emergency is over, “then any EUA(s) issued based on that declaration will no longer remain in effect,” according to the FDA.

Among the two other coronavirus vaccines authorized for emergency use in the United States, Moderna has begun applying for full approval for its Covid-19 vaccine in people ages 18 and up. Johnson & Johnson has not yet filed for full FDA approval of its vaccine.

Some experts have pushed the FDA to approve vaccines quickly, as doing so could help combat vaccine hesitancy.
Full approval of the Covid-19 shots comes days after the Biden administration announced plans to offer booster doses to vaccinated adults starting September 20 — pending approval by the FDA and recommendation from the US Centers for Disease Control and Prevention.

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