Pfizer and BioNTech are asking drug regulators in the United States for full approval for their COVID-19 vaccines. The two companies announced on Friday that they initiated a rolling submission for a biologics license application by submitting nonclinical and clinical data, including the most recent analyses from a Phase 3 clinical trial, to the Food and Drug Administration (FDA) in the coming weeks. They plan on submitting more data in the coming weeks to complete the application. “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, Pfizers’ chairman and 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.” “The BLA submission is an important cornerstone of …
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