Moderna has completed its submission to the US Food and Drug Administration for full approval of its Covid-19 vaccine for people age 18 and older
Moderna said it has requested priority review from the agency. The company began submitting data for its Biologics License Application, or BLA, to the FDA in June."This BLA submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company's history," Moderna CEO Stéphane Bancel said in a statement.
Even with priority review, the approval process typically takes months; the FDA moved resources around in order to be able to approve the Pfizer/BioNTech vaccine in less time.Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said Monday that the agency worked around the clock to conducts its own analyses and inspect facilities, completing all the same work it would for any approval.
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