Arexvy: Canada approves GSK's RSV vaccine

GSK has received Canadian approval for Arexvy, 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 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.