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Friday, December 09, 2022 7:04:24 AM
Pfizer had more good news Wednesday. According to the company, the U.S. Food & Drug Administration accepted for priority review a Biologics License Application (BLA) for a respiratory syncytial virus (RSV) vaccine candidate submitted by Pfizer. The treatment should prevent respiratory tract disease caused by that particular virus in people ages 60 and older....
Priority review designation by the FDA cuts the standard BLA review time period by four months.
In a statement issued by Pfizer, Annaliesa Anderson, senior vice president and chief scientific officer of vaccine research and development, said, "With no RSV vaccines currently available, older adults remain at risk for RSV disease and potential severe outcomes, including serious respiratory symptoms, hospitalization, and in some cases, even death.”....
She noted that the FDA’s acceptance of the BLA for the company’s vaccine candidate is an important regulatory milestone."
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