Pfizer’s two-dose Covid-19 vaccine becomes the first vaccine in the US to receive full approval from the Food and Drug Administration (FDA).
The vaccine had initially been given emergency use authorization. Both of its shots are now fully approved for those aged 16 and older.
In a statement, the FDA said its review for approval included data from approximately 44,000 people.
Acting FDA Commissioner Janet Woodcock said that the public “can be very confident” the vaccine meets high safety, effectiveness, and manufacturing quality standards.
President Biden spoke directly to the “millions” of Americans he said were waiting for full and final FDA approval in a televised address.
“The moment you’ve been waiting for is here,” he said. “It’s time for you to go get your vaccination. Get it today.”
Additionally, Mr. Biden called on private sector companies and nonprofits to require employees to get vaccinated.
The approval is expected to set off more vaccine mandates by employers and organizations across the country.
Following the announcement, the US military said they would officially require all 1.3m active-duty US troops to get vaccinated.
The vaccine, which will now be marketed as Comirnaty, was found to be 91% effective in preventing Covid disease.
The FDA initially gave Pfizer temporary authorization – a clearance given if the agency determines the benefits of a product outweigh potential risks during a public health emergency.
It comes amid lingering vaccine hesitancy among many Americans.
Critics had been calling on the FDA to speed up this approval process as the nation struggled with dropping vaccination rates earlier this year.
While the agency took steps to increase staff and resources, it had previously said it would take six months to get the required data.
Polling data released at the end of June by the Kaiser Family Foundation found that about 30% of unvaccinated American results said they would be more likely to get a vaccine if it received full FDA approval. The number rises to nearly 50% among Americans taking a “wait and see” approach to vaccines.
Companies, healthcare systems, universities, and other organizations are now expected to announce vaccine requirements as the country embarks on a return to normalcy.
To date, more than 92 million vaccinated Americans – more than half of the total – have received the Pfizer vaccine.