(Reuters) -The European Union health regulator on Friday recommended expanded use of GSK’s respiratory syncytial virus (RSV) vaccine in adults aged between 50 and 59.
Any recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use has to be formally approved by the European Commission, which usually follows the regulator’s decision.
The vaccine, branded Arexvy, was approved by the U.S. Food and Drug Administration in June but the Centers for Disease Control and Prevention (CDC) did not recommend RSV shots for adults under 60 years.
The CDC had recommended that adults aged 75 and older, as well as those between the ages of 60 and 74 at an increased risk of severe RSV due to medical conditions, should receive shots against the virus.
The recommendation downsized GSK’s U.S. market for the shot in 2024-25 from 93 million to about 55 million, according to analysts.
GSK had forecast peak annual sales of more than 3 billion pounds for the vaccine.
(Reporting by Prerna Bedi in Bengaluru; Editing by Shounak Dasgupta)
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