U.S. FDA grants priority review to Pfizer's RSV vaccine
Send a link to a friend
[December 07, 2022]
(Reuters) -Pfizer Inc said on Wednesday the U.S. Food and Drug
Administration will review its respiratory syncytial virus (RSV) vaccine
candidate on priority.
The drugmaker is seeking approval for use of the vaccine, RSVpreF, in
adults aged 60 years and older and the agency is set to make its
decision by May 2023. It could become the first approved RSV vaccine in
the U.S. for older adults who are at risk of the lung disease.
Pfizer's application to the FDA is supported by data from a late-stage
study in which the vaccine was found safe and effective.
The vaccine was 85.7% effective among participants with three or more
symptoms, and 66.7% for two or more symptoms, according to an interim
analysis carried out by an external data monitoring panel.
[to top of second column]
|
A compagny logo is seen at a Pfizer
office in Puurs, Belgium, December 2, 2022. REUTERS/Johanna Geron
There are no U.S. approved vaccines
for RSV, a common virus that typically causes mild cold-like
symptoms but can be fatal for young kids and older adults. RSV is
estimated to cause about 14,000 annual deaths among older adults in
the United States.
(Reporting by Bhanvi Satija and Khushi Mandowara in Bengaluru;
Editing by Krishna Chandra Eluri)
[© 2022 Thomson Reuters. All rights
reserved.] This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content. |