US FDA approves first RSV vaccine from GSK
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[May 04, 2023]
(Reuters) -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.
![](http://archives.lincolndailynews.com/2023/May/04/images/ads/current/culligan_sda_SFARM_2023.png)
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.
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![](../images/050423PIX/health2.jpg)
Signage is seen outside of the Food and
Drug Administration (FDA) headquarters in White Oak, Maryland, U.S.,
August 29, 2020. REUTERS/Andrew Kelly
![](http://archives.lincolndailynews.com/2019/Sep/05/images/ads/current/stclara_lda_SPONSOR_090519.png) The question on how often the
vaccine should be given is to be placed before CDC's panel of
advisors on immunization. The RSV vaccination is a topic that is
expected to be discussed, when the panel is set to meet in late
June, a CDC spokesperson told Reuters.
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.
(Reporting by Mariam Sunny, Raghav Mahobe, Bhanvi Satija and Aditya
Samal in Bengaluru and Maggie Fick in London; Editing by Anil
D'Silva and Shailesh Kuber)
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