Pfizer gets FDA panel's backing in RSV vaccine race
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[March 01, 2023]
By Khushi Mandowara and Mariam ESunny
(Reuters) - A panel of outside advisers to the U.S. health regulator on
Tuesday recommended Pfizer Inc's respiratory syncytial virus (RSV)
vaccine, bringing it closer to becoming one of the first approved RSV
shots for older adults in the United States.
The Food and Drug Administration's (FDA) advisory committee voted 7-4 in
favor of the vaccine, saying data from the company's study established
that the shot was effective and safe in preventing lower respiratory
tract disease caused by RSV in people aged 60 years and older. One
member abstained during voting.
GSK, which is another forerunner in a crowded race to develop the first
RSV vaccine, will face scrutiny from a panel of experts to the FDA on
Wednesday.
Companies such as Johnson & Johnson, Moderna Inc and Merck are also
looming on the horizon.
While panelists backed Pfizer's vaccine, concerns were voiced over
insufficient efficacy data in the company's study for adults 80 and
above, who need the vaccine the most, and suggested a need for detailed
post-marketing safety surveillance to address issue of any serious
adverse event.
"The population where the vaccine is going to potentially have the
biggest impact is less represented in this study," said Hana Sahly, one
of the 12 FDA panelists.
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![](../images/030123PIX/health69.jpg)
Pfizer logo is seen in this illustration
taken, May 1, 2022. REUTERS/Dado Ruvic/Illustration/
![](http://archives.lincolndailynews.com/2023/Mar/01/images/ads/current/graue_lda_22COLORADOpreowned_022023.jpg) The first approved vaccines for the
virus, which kills roughly 14,000 older adults in the United States
annually, could help the firms gain a foothold in a market estimated
at $5 billion to $10 billion, according to analysts.
The FDA is scheduled to decide on the vaccines by May, and typically
follows the recommendations of its independent panel of experts.
Pfizer's vaccine was 66.7% effective in preventing RSV-related lower
respiratory tract illness with over two symptoms, while GSK's
vaccine was 82.6% effective in preventing lower respiratory tract
disease in people aged 60 and over.
(Reporting by Manas Mishra, Khushi Mandowara, Mariam E Sunny in
Bengaluru and Michael Erman in New York; Editing by Caroline Humer,
Sriraj Kalluvila and Maju Samuel)
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