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Pfizer, BioNTech begin process seeking full FDA approval for COVID vaccine

Pfizer and BioNTech said they are starting the process to request full FDA approval for their COVID-19 vaccine.

WASHINGTON — Drugmakers Pfizer and BioNTech on Friday announced they started the process to request full approval from the U.S. Food and Drug Administration for their mRNA coronavirus vaccine.

The FDA has only given Emergency Use Authorization in December 2020 for the two-dose vaccine to be used on individuals 16 years of age and older. Since receiving the Emergency Use Authorization, more than 170 million doses of the vaccine have been delivered across the U.S.

Pfizer and BioNTech said data to support its vaccine will be submitted to the FDA on a "rolling basis" over the coming weeks. The companies requested a priority review, which asks the FDA to fast-track the application within six months instead of the usual 10 months.

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“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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “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.”

To apply for full approval from the FDA, the companies need to submit a Biologics License Application or BLA. These include the most recent analyses on its Phase 3 clinical trial, which found that its vaccine is effective up to six months after the second dose.

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The companies said they are currently just requesting approval for adults 16 years and older. Pfizer/BioNTech said they plan to submit an additional BLA to cover younger age groups once they collect efficient data.

“Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”

For most people, the coronavirus causes mild or moderate symptoms. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia and death.

The United States has more than 32 million confirmed cases of COVID-19, according to data from Johns Hopkins University.

As of Friday, the U.S. had more than 580,000 deaths from the virus. Worldwide, there are more than 156 million confirmed cases with more than 3.2 million deaths.