EU Health Regulator Endorses GSK's RSV Vaccine for Expanded Age Group

The European Union's health regulator has recommended the expanded use of GSK's respiratory syncytial virus (RSV) vaccine for adults aged 50-59. The decision is pending formal approval by the European Commission. The CDC had previously limited RSV vaccine recommendations in the U.S., impacting GSK's market size.

The European Union health regulator on Friday recommended the expanded use of GSK's respiratory syncytial virus (RSV) vaccine for adults aged 50 to 59 years.

The European Medicines Agency's Committee for Medicinal Products for Human Use made the recommendation, which now requires formal approval from the European Commission. Approval is typically in line with the health regulator's decision. The vaccine, Arexvy, had previously received approval from the U.S. Food and Drug Administration in June. However, the Centers for Disease Control and Prevention (CDC) did not advise RSV shots for adults under 60 years of age.

Currently, the CDC recommends RSV vaccination for adults aged 75 and older, and those between 60 and 74 who are at a higher risk due to medical conditions. This decision significantly reduced GSK's U.S. market for the vaccine from an anticipated 93 million to approximately 55 million people for the 2024-25 period, according to analysts.

GSK had projected peak annual sales of the vaccine to exceed 3 billion pounds.