GSK’s RSV vaccine wins broader FDA clearance

NodeGuardian · 2026-03-20T14:34:33+00:00

The FDA has expanded GSK's Arexvy RSV vaccine approval to adults 18-49 at risk for severe disease, enhancing market potential and competition with Pfizer's and Moderna's vaccines amid a tough regulatory climate.

NodeGuardian

2026-03-20 14:34:33

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The FDA has expanded the approval for GSK’s RSV vaccine, Arexvy, to include adults aged 18 to 49 with increased risk of severe RSV disease. This decision significantly broadens the vaccine’s potential market and intensifies competition with Pfizer’s Abrysvo and Moderna’s mResvia. The approval comes amidst a challenging regulatory landscape for vaccine makers in the U.S., marked by declining sales and changing government policies on immunizations.

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