Pfizer, BioNTech seek full FDA approval for COVID-19 vaccine
Companies announced initiation of a BLA, said data will be submitted on a rolling basis over coming weeks
Pharmaceutical Research and Manufacturers of America CEO Stephen Ubl argues waiving the COVID-19 vaccine patent would hinder U.S. efforts to ramp up supply, undermine U.S. leadership and upend intellectual property protection.
Pfizer and BioNTech said Friday that they have begun the process of seeking full FDA approval for their COVID-19 vaccine.
The companies announced the initiation of a Biologics License Application (BLA) with the agency and said data will be submitted on a rolling basis over the coming weeks, potentially paving the way for full approval within the next several months.
The BLA is the next step following emergency use authorization, which the companies received in December. The FDA is currently reviewing a request to expand the existing EUA to include adolescents ages 12-15.
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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," Albert Bourla, Pfizer CEO, 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."
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Over 168.6 million doses of the Pfizer-BioNTech mRNA two-shot vaccine have been delivered across the U.S., with more than 134.1 million jabs administered. On Thursday, the companies announced an agreement in which they will provide COVID-19 vaccines to athletes competing in the Tokyo Olympics.