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FDA clears GSK's RSV vaccine for adults ages 50-59

By Ehren Wynder
GSK's Arexvy became the first FDA-approved RSV vaccine in May 2023. File photo by EPA-EFE
GSK's Arexvy became the first FDA-approved RSV vaccine in May 2023. File photo by EPA-EFE

June 8 (UPI) -- The U.S. Food and Drug Administration approved GSK's respiratory syncytial virus vaccine for high-risk adults ages 50 to 59, expanding the shot's accessibility to younger patients.

GSK's Arexvy became the first FDA-approved RSV vaccine in May 2023. At the time, it was only cleared for use on adults aged 60 and older, who are more vulnerable to severe cases of RSV lower respiratory tract disease.

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"Today's approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50 to 59 who are at increased risk," Tony Wood, chief scientific officer, GSK, said in a statement Friday. "For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD."

The company's application for FDA approval followed results from a late-stage trial that showed immune responses to the vaccine in high-risk adults ages 50 to 59 were similar to those observed in adults 60 and over who received the jab.

Side effects included mild to moderate fatigue, headaches and muscle pain.

More than13 million Americans ages 50 to 59 have a medical condition that increases their risk of having a severe RSV outcome according to GSK. The virus causes and estimated 2,000 hospitalizations in adults ages 50 to 64 every year.

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Arexvy won't reach the younger demographic immediately. A Centers for Disease Control and Prevention advisory panel is set to vote in June on recommendations for the shot, as well as rival shots from Pfizer and Moderna.

GSK, meanwhile, is pursuing regulatory approval to expand the vaccine's age range in Europe, Japan and other countries. The company also is studying the vaccine's application in high-risk and immunocompromised adults ages 18 to 49.

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