May 10, 2021 -- Pfizer and its European partner BioNTech are seeking the FDA’s full approval for their COVID-19 vaccine, which is already being widely administered in the United States under an emergency use authorization.

If the FDA says yes, Pfizer would be the first COVID vaccine to gain full approval in the United States.

In a news release, Pfizer said it will initiate a Biologics License Application and submit information to the FDA on a rolling basis over the coming weeks. The vaccine application is only for people 16 and over.

Pfizer says it’s seeking a priority review, which the FDA defines as “a 6-month review of the entire BLA rather than the usual 10-month review.”

How would full approval affect the public?

Schools, government agencies, and companies would be more likely to require vaccinations, The New York Times reported. Many organizations have been urging vaccinations but holding off on making them a requirement until the FDA formally approves a vaccine, the Times said.

The Equal Opportunity Commission said in December that employers can create a mandatory vaccine policy that requires most employees to get a COVID-19 vaccine.

FDA approval also might put a dent into vaccine hesitancy among the public. The government says demand for vaccines is slowing.

All COVID vaccines being used in the U.S. were granted an emergency use authorization, which the FDA grants for a medical product that’s needed because of a public health emergency.

Pfizer was the first vaccine to receive an EUA in the United States, in December.

The CDC says that 134 million doses of the Pfizer vaccine have been administered in the United States, compared to 109 million doses of Moderna vaccine and 8.6 million doses of the Johnson & Johnson vaccine.

Pfizer is also seeking an EUA for a vaccine to be given to children 12-15 years old

"We are proud of the tremendous progress we've made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government," Albert Bourla, chairman and chief executive officer of Pfizer, said in a statement. "We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months."

WebMD Health News Brief

Sources

Pfizer. “PFIZER AND BIONTECH INITIATE ROLLING SUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR U.S. FDA APPROVAL OF THEIR COVID 19 VACCINE”

NYT. Pfizer and BioNTech apply for full U.S. approval for their Covid vaccine

FDA. Regulatory Perspective on Development of Preventive Vaccines for Global Infectious Diseases 

FDA. Emergency Use Authorization

CDC Vaccine Tracker

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