GSK Seeks FDA Nod To Broaden RSV Vaccine For Younger At-Risk Adults

On Monday, the U.S. Food and Drug Administration (FDA) agreed to review GSK plc’s (NYSE:GSK) application to extend the indication of Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18-49 who are at increased risk.

GSK's RSV vaccine is approved in the U.S. to prevent lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, as well as those aged 50-59 years at increased risk for LRTD caused by RSV.

RSV, a common contagious virus affecting the lungs and breathing passages, impacts an estimated 64 million people of all ages globally every year. More than 125 million adults in the U.S. are under 50. An estimated 21 million of these people have at least one diagnosed risk factor for severe RSV infection, such as chronic obstructive pulmonary disease, asthma, congestive heart failure, and coronary heart disease.

The regulatory submission is supported by a Phase 3b trial evaluating immune response and safety in adults aged 18-49 who are at increased risk compared to adults aged 60 and above.

The safety and reactogenicity data were consistent with those from the Phase 3 program, which supported the vaccine’s initial approval in the U.S.

A regulatory decision by the FDA on this submission is expected in the first half of 2026.

In June, the FDA expanded approval of Moderna Inc.'s (NASDAQ:MRNA) respiratory syncytial virus vaccine to adults aged 18-59 at increased risk for disease. That same month, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Merck & Co Inc's (NYSE:MRK) Enflonsia (clesrovimab-cfor) as an option for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants younger than 8 months of age who are born during or entering their first RSV season.

With a five-to-two majority, RFK Jr.'s newly constituted committee made its first ruling. This body was formed after RFK Jr. entirely replaced the previous 17-member panel with his selections.

Also, in June, Sanofi SA (NASDAQ:SNY) announced that it will begin shipping Beyfortus (nirsevimab) in early Q3 to ensure broad availability well ahead of the 2025-2026 respiratory syncytial virus (RSV) season, which typically starts in November and runs through March.

In collaboration with its partner AstraZeneca plc (NASDAQ:AZN), Sanofi has tripled production capacity and doubled the number of manufacturing sites since the launch of Beyfortus in 2023.

Last week, GSK announced it has started shipping doses of its trivalent seasonal influenza vaccines to U.S. healthcare providers and pharmacies in preparation for the 2025-26 flu season.

This immediately follows FDA licensing and approval of the lot release. FLULAVAL and FLUARIX will be available in a 0.5mL, single-dose, pre-filled syringe and are indicated for people six months and older.

Price Action: GSK stock is down 1.36% at $37.77 at the last check on Tuesday.

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