12/7/2022
Pfizer Inc. on Wednesday said the U.S. Food and Drug Administration granted priority review to its application seeking approval of its RSVpreF respiratory syncytial virus vaccine candidate in older adults.
The New York drugmaker said the application covers the prevention of lower respiratory tract disease caused by respiratory syncytial virus, commonly referred to as RSV, in individuals ages 60 and older.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Pfizer said the agency has set a target action date in May 2023 for the application.
RSV, a common respiratory virus that people get many times over the course of their lives, can cause serious illness in the very old and young. The virus has hit earlier than usual this year, causing a surge of cases in emergency rooms and pediatric hospitals.
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