US panel backs GSK vaccine, heating up RSV vaccine race

[March 02, 2023]  By Khushi Mandowara and Mariam ESunny

(Reuters) -A panel of outside advisers to the U.S. health regulator on Wednesday backed GSK Plc's respiratory syncytial virus (RSV) vaccine, setting it up for a race with rival Pfizer to become the first approved U.S. shot against the disease. The Food and Drug Administration's (FDA) advisory committee voted unanimously in favor of the vaccine's effectiveness in preventing lower respiratory tract disease caused by RSV in adults aged 60 and above, and voted 10 to 2 for its safety.

The panelists seemed significantly more confident about the demographic profile used during the GSK study in comparison to Pfizer's RSV vaccine, which was recommended by the FDA panel on Tuesday.

"The population is more representatives of those who are going to get the disease... giving me a lot of comfort in the vaccine" said Jay Portnoy, one of the 12 FDA panelists, about the GSK shot.

Pfizer and GSK are running a tight race to tap into the RSV vaccine market, which is estimated to be over $5 billion and could exceed $10 billion by 2030, according to analysts.

There is currently no approved vaccine to prevent lower respiratory tract disease caused by RSV in older adults, which causes death of 14,000 adults aged 65 and older annually in the United States.

GSK (GlaxoSmithKline) logo is seen in this illustration, August 10, 2022. REUTERS/Dado Ruvic/Illustration

The FDA is scheduled to decide on the vaccines by May, and typically follows the recommendations of its independent panel of experts.

In October, late-stage data of GSK's RSV vaccine showed it to be 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over, while Pfizer's vaccine was 66.7% effective.

If approved, we estimate peak sales for GSK vaccine to be about $2.8 billion globally, said Evan Wang, Guggenheim Securities analyst, ahead of the panel vote.

(Reporting by Khushi Mandowara and Mariam E Sunny in Bengaluru; Editing by Shinjini Ganguli)

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