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

FDA Approves First RSV Vaccine from GSK

RSV entry in medical book, pills, syringe
(Dreamstime)

Wednesday, 03 May 2023 01:31 PM EDT

The U.S. Food and Drug Administration has approved GSK Plc's respiratory syncytial virus (RSV) vaccine, the British drugmaker said on Wednesday, making it the first shot to be cleared for protection against a common respiratory disease that can be fatal for older people.

The vaccine, Arexvy, was approved for people aged 60 and older, the company said.

The approval makes GSK, which has been neck-and-neck with Pfizer in RSV vaccine development, the first company to tap into a multi-billion-dollar market and also puts it ahead of rivals such as Moderna Inc and Bavarian Nordic.

Analysts have estimated the market for RSV vaccines to surpass $10 billion by 2030. Credit Suisse analysts expect $2.5 billion in peak sales for GSK's RSV vaccine for older adults.

GSK expects the vaccine to be available before the next RSV season in the United States, Chief Commercial Officer Luke Miels told Reuters on Wednesday, ahead of the approval.

He said the vaccine would be priced above $120 per shot provided the data from a study, which is expected soon, shows that it offers protection for two RSV seasons.

RSV cases in the most recent season started last year in June and peaked in November, the U.S. Centers for Disease Control and Prevention (CDC) said.

The question on how often the vaccine should be given is to be placed before CDC's panel of advisors on immunization. The panel is scheduled to meet in June and the agenda was not immediately clear.

The CDC did not immediately respond to a Reuters request for comment.

RSV is responsible for 14,000 deaths in adults aged 65 and older annually in the United States, according to government estimates.

GSK's vaccine showed overall efficacy of 82.6% and was about 94% effective against severe lower respiratory tract disease associated with an RSV infection among participants aged 60 and older in its late-stage trial.

© 2024 Thomson/Reuters. All rights reserved.


Health-News
The U.S. Food and Drug Administration has approved GSK Plc's respiratory syncytial virus (RSV) vaccine, the British drugmaker said on Wednesday, making it the first shot to be cleared for protection against a common respiratory disease that can be fatal for older people. The...
respiratory syncytial virus, rsv, vaccine, fda, approval, first, gsk
311
2023-31-03
Wednesday, 03 May 2023 01:31 PM
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