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.
March 1 - A panel of outside advisers to the U.S. health regulator on Wednesday backed GSK Plc's
respiratory syncytial virus 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 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"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.
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