• February 26, 2024

Pfizer Seeks Full FDA Approval For COVID-19 Vaccine : Coronavirus Updates : NPR

Pfizer-BioNTech is filing for FDA approval for its COVID-19 vaccine with the aim of getting the agency green light “in the coming months”. Ben Hasty / MediaNews Group / ReadingEagle via Getty Images Hide caption

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Ben Hasty / MediaNews Group / ReadingEagle via Getty Images

Pfizer-BioNTech is filing for FDA approval for its COVID-19 vaccine with the aim of getting the agency green light “in the coming months”.

Ben Hasty / MediaNews Group / ReadingEagle via Getty Images

Pfizer and its vaccine partner BioNTech have filed an application to seek Food and Drug Administration approval for the COVID-19 vaccine.

Pfizer is the first coronavirus vaccine manufacturer in the United States to apply for full approval. Like Pfizer, Moderna and Johnson & Johnson vaccines had previously been approved for use by the Agency Emergency approval – a less stringent approval method to support a faster response to the pandemic.

A FDA approval For a vaccine, this means that after reviewing the manufacturer’s test results, the agency decided that its benefits outweigh any known risks.

If granted, Pfizer’s full seal of approval will only apply to the vaccine for individuals 16 years of age and older. In the meantime, the vaccine maker is applying for approval to use its COVID-19 vaccine for emergency purposes for children aged 12-15.

“We look forward to working with the FDA to complete this ongoing filing and support its review with the aim of ensuring full regulatory approval for the vaccine in the months ahead,” said Albert Bourla, CEO of Pfizer a press release on Friday.

Dr. Ugur Sahin, CEO of BioNTech, described the filing of the application for FDA approval as “an important cornerstone for achieving long-term herd immunity and the future containment of COVID-19”.

“We are excited to be working with US regulators to apply for approval of our COVID-19 vaccine based on our key Phase 3 study and follow-up data.”

In this final phase of clinical trials, Pfizer determined that it was a vaccine 95% effective against COVID-19, the highest efficacy of any emergency vaccine approved in the United States

In order for the FDA to approve, Pfizer-BioNTech must meet an important requirement: to provide follow-up data six months after vaccination.

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