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.