FDA grants full approval to Pfizer’s Covid-19 vaccine

Behrouz Mehri/Pool Photo via AP


(CNN) – 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 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.

Albert Bourla, the chair and chief executive officer of Pfizer, said the decision reaffirms the vaccine’s safety.

“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans,” Bourla said.

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.”

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