Pfizer Gets FDA Priority Review of RSV Vaccine Candidate in Older Adults
07 Diciembre 2022 - 6:57AM
Noticias Dow Jones
By Colin Kellaher
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.
There are currently no prophylactic, therapeutic or vaccine
options for RSV for older adults, Pfizer said.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 07, 2022 07:42 ET (12:42 GMT)
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