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Canada approves GSK's RSV vaccine for adults aged 50 to 59
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Canada approves GSK's RSV vaccine for adults aged 50 to 59
Nov 5, 2024 8:56 AM

Nov 5 (Reuters) - GSK has received Canadian

approval for its respiratory syncytial virus vaccine in adults

between 50 and 59, the company said on Tuesday, making it the

country's first authorized RSV shot for that age group.

The U.S. Centers for Disease Control and Prevention decided

to hold off recommending the use of the vaccine, Arexvy, in

adults under 60, despite the Food and Drug Administration

approving it for that age group.

Arexvy is already approved in the United States and the

European Union for use in adults between 50 and 59. It was

previously approved only for those 60 and older in Canada, as is

Pfizer's ( PFE ) RSV vaccine, Abrysvo.

RSV, which typically causes cold-like symptoms, is a leading

cause of pneumonia in toddlers and older adults.

Hospitalizations associated with RSV in adults start to

increase at the age of 50, GSK's interim Canada medical

director, Michelle Horn, said.

Among Canadian adults 50 and older who are hospitalized with

RSV, about 98% have at least one chronic condition, according to

GSK.

The company has also filed regulatory submissions for the

approval of Arexvy in adults aged 50 to 59 in Japan and other

countries.

It expects to release data from two studies of the vaccine

in adults 18 and above later in 2024.

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