The U.K. drugmaker GSK is seeking to expand regulatory approval for its new respiratory syncytial virus vaccine to include younger adults, even as other manufacturers’ new RSV products face shortages across the U.S.
Analysts and executives say that uptake of the RSV vaccines for older adults from GSK and Pfizer has so far been strong, despite a lukewarm recommendation from the influential vaccines advisory committee of the Centers for Disease Control and Prevention. Over the long term, the high demand for RSV prophylactics points to the products developing into substantial blockbusters for these companies. GSK expects sales of its RSV shot Arexvy to peak at more than £3 billion, or $3.6 billion, while Pfizer has said it expects its shot Abrysvo to peak above $2 billion in annual sales.
For now, GSK is looking to expand its approval to allow younger adults to receive the shot. The company said Monday that early results from a new Phase 3 study show the immune responses elicited in adults aged 50 to 59 by the vaccine weren’t worse than those seen in adults aged 60 and above. GSK said it will be the “first company” to hand regulators data on that age group, and that approval could come next year.
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