Pfizer starts application for full FDA approval of its COVID-19 vaccine
Pharmaceutical company Pfizer has started its application to the U.S. Food and Drug Administration for full approval of its COVID-19 vaccine.
Since December, Pfizer has been authorized on an emergency use basis and has delivered more than 170 million doses of the shot to people 16 and older. Emergency use authorization only lasts as long as the emergency declared by the country.
Full approval would allow use beyond those limits.
In this photo illustration, a silhouette of hands in medical gloves holds a medical syringe and a vial in front of the Pfizer logo of a US pharmaceutical industry company. (Photo Illustration by Pavlo Gonchar/SOPA Images/LightRocket via Getty Images)
Along with vaccines by Moderna and Johnson & Johnson, Pfizer’s product has accelerated America’s recovery from the pandemic.
Since the winter surge, cases have plummeted, as have the hospitalization and death rates — relieving the health care system.
"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," Pfizer’s Chairman and Chief Executive Officer Albert Bourla said. "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."
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The Biologics License Application (BLA) process involves submitting data nonclinical and clinical data to support licensure of the COVID-19 vaccine.
Pfizer will submit the data over the coming weeks, then seek priority review, which would cause the FDA to take action within six months, instead of the typical 10-month time frame.
"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," BioNtech CEO Dr. Ugur Sahin said. "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."
Full approval would only apply to people 16 and older. Pfizer is also seeking expansion of its EUA for children between 12 and 15 years old.
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Canada approved Pfizer’s vaccine for that age group and the FDA is expected to do the same by next week.
This story was reported from Atlanta.