The British Pharmaceutical Laboratory GSK announced on Monday that it had applied to the American Food and Drug Products (FDA) agency in order to extend the use of its syncytial respiratory virus vaccine (RSV) to adults under 50 with an increased risk of contracting the disease.
If this authorization was granted on the largest global pharmaceutical market, the GSK vaccine, Arexvy, would then compete for the market share of 18-49 year olds with the Mresvia de Moderna and the Abrysvo de Pfizer.
The RSV is a common respiratory virus responsible for seasonal infections similar to flu and is one of the main causes of pneumonia and mortality in infants as well as in the elderly.
The GSK vaccine is currently approved in the United States for the prevention of RSV diseases in adults aged 60 and over, as well as in adults at risk aged 50 to 59. Although GSK benefited from an advance during the first authorizations, the company has since lagged behind its competitors and sales have dropped sharply.
According to GSK, the FDA should make its decision concerning the expansion of the use of Arexvy in the first half of 2026. The European authorities should also decide on a similar request by then.