Moderna has requested the FDA's full approval of its COVID-19 vaccine for adults ages 18 and older.
under FDA emergency use authorization for ages 18 and older. The company has also filed for emergency use authorization for ages 12 and older.
The news comes after the FDA fully approved Pfizer’s COVID-19 vaccine on Monday for ages 16 and older. If Moderna receives full approval, its vaccine would be the second COVID-19 shot available under full FDA approval.. The FDA reviews thousands of documents on safety and efficacy, does its own analyses, and inspects facilities.
To approve the Pfizer vaccine, the agency pulled in extra resources to complete the process as soon as possible, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, told CNN on Monday. “It’s actually 97 days since Pfizer completed the role of its BLA and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude,” he said.Moderna: “Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine.”CNN: “Moderna completes submission for full FDA approval of Covid-19 vaccine.
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