LONDON — The European Commission approved GSK’s RSV vaccine, the company said Wednesday, bringing to the market the first such tool that can protect older adults from the common respiratory bug.
The vaccine, Arexvy, was authorized for adults 60 and older. Arexvy won U.S. regulatory licensure last month, as did another RSV immunization, Pfizer’s Abrysvo. The European Medicines Agency is reviewing Pfizer’s vaccine.
GSK said it plans to launch Arexvy in Europe before RSV season takes off in the fall. With the European approval, the company now has to reach reimbursement deals in each country in the European Union.
Scientists have been working for decades to develop RSV vaccines. While the bug — respiratory syncytial virus — typically just causes mild colds for most people, it can cause serious illness in older adults and babies.
In Europe each year, RSV puts more than 270,000 older adults in the hospital and causes some 20,000 deaths.
“This authorization for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK’s long history of vaccine innovation,” Tony Wood, the company’s chief scientific officer, said in a statement. “Our strong manufacturing capability and scale, including from our vaccine manufacturing site in Belgium, means we are ready to deliver the vaccine as countries begin to launch.”
In the United States, the Centers for Disease Control and Prevention must first recommend the RSV shots before they become available. It’s expected the CDC will issue its recommendation following a meeting of its vaccine expert advisory committee later this month.