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US drug regulator grants full approval to Pfizer-BioNTech Covid-19 vaccine

The US Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people aged 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.

“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.

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