×
Newsmax TV & Webwww.newsmax.comFREE - In Google Play
VIEW
×
Newsmax TV & Webwww.newsmax.comFREE - On the App Store
VIEW
Tags: rsv | respiratory syncytial virus | fda | vaccine | priority | review

FDA Grants Priority Review to Pfizer's RSV Vaccine

baby in hospital with RSV, oxygen in nose
(Dreamstime)

Wednesday, 07 December 2022 07:32 AM EST

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.

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.

© 2023 Thomson/Reuters. All rights reserved.


Health-News
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...
rsv, respiratory syncytial virus, fda, vaccine, priority, review
171
2022-32-07
Wednesday, 07 December 2022 07:32 AM
Newsmax Media, Inc.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 
Find Your Condition
Get Newsmax Text Alerts
TOP

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved
NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved