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GSK reports FDA approves expanded age indication for AREXVY

On Friday night, GSK plc announced that the Food and Drug Administration has approved AREXVY Respiratory Syncytial Virus, or RSV, Vaccine, Adjuvanted, for the prevention of RSV lower respiratory tract disease in adults 50 through 59 years of age who are at increased risk. In the U.S., the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making. Tony Wood, Chief Scientific Officer, GSK, said: “Today’s approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk. 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.”

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