GSK's RSV Vaccine Receives FDA Review for Expanded Use in Young Adults

GSK's RSV vaccine, Arexvy, has been accepted for review by the FDA to extend its indication to adults aged 18-49 who are at increased risk. The vaccine is currently approved in the US for adults aged 60 and older, and those aged 50-59 who are at increased risk. A regulatory decision is expected in H1 2026. GSK is also seeking expanded indications for the vaccine in other geographies, including the European Economic Area and Japan.

GSK's RSV vaccine, Arexvy, has been accepted for review by the FDA to extend its indication to adults aged 18-49 who are at increased risk. The vaccine is currently approved in the US for adults aged 60 and older, and those aged 50-59 who are at increased risk. A regulatory decision is expected in H1 2026. GSK is also seeking expanded indications for the vaccine in other geographies, including the European Economic Area and Japan.

The Centers for Disease Control and Prevention (CDC) recommends a single dose of RSV vaccine for all adults aged 75 and older, and for adults aged 50-74 at increased risk of severe RSV disease. Three RSV vaccines are currently available: GSK's Arexvy, Moderna's mResvia, and Pfizer's Abrysvo [1].

GSK's Arexvy has shown real-world effectiveness of approximately 77% in preventing RSV-associated emergency department encounters and 83% in preventing RSV-associated hospitalizations in adults 60 and older during the 2023-2024 RSV season. The vaccine also demonstrated effectiveness among adults with certain immunocompromising conditions and those with end-stage renal disease [1].

The expansion of Arexvy's indication to adults aged 18-49 who are at increased risk aligns with the CDC's recommendation for RSV vaccination for this age group. The vaccine's effectiveness and safety profile in this population will be closely monitored by the FDA and the CDC. If approved, this expansion could significantly impact GSK's market share in the RSV vaccine market and provide additional revenue streams.

GSK's ongoing efforts to expand Arexvy's indications in other geographies, including the European Economic Area and Japan, further underscore the company's commitment to addressing the global burden of RSV disease. These efforts also present potential opportunities for increased revenue and market growth.

Investors and financial professionals should closely monitor the regulatory review process for Arexvy's expanded indications and the potential impact on GSK's financial performance. The success of these efforts could have significant implications for the company's stock price and market valuation.

References:
[1] https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/adults.html