GSK has received Canadian approval for its respiratory syncytial virus vaccine in adults aged 50 to 59, the company said Tuesday, making it the first RSV vaccine authorized in the country for this group of people. age.
The U.S. Centers for Disease Control and Prevention has decided not to recommend the Arexvy vaccine for use in adults younger than 60, although the Food and Drug Administration has approved it for that age group.
Arexvy is already approved in the United States and the European Union for adults aged 50 to 59. Previously, it was only authorized for people aged 60 and older in Canada, just like Pfizer’s RSV vaccine, Abrysvo.
RSV, which usually causes cold-like symptoms, is a leading cause of pneumonia in young children and older adults.
RSV-associated hospitalizations among adults begin to increase at age 50, said Michelle Horn, GSK’s interim medical director in Canada.
According to GSK, approximately 98% of Canadian adults aged 50 and older hospitalized due to RSV have at least one chronic illness.
The company has also filed applications for Arexvy in adults ages 50 to 59 in Japan and other countries.
It plans to release data from two studies of the vaccine in adults 18 and older sometime in 2024.
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