On Friday, the U.S. Food and Drug Administration (FDA) expanded the approved age indication for GSK plc’s (NYSE:GSK) respiratory syncytial virus vaccine, Arexvy.

The approval allows its use in adults aged 18 to 49 who face a higher risk of lower respiratory tract disease caused by RSV.

The vaccine was previously approved to prevent RSV-related lower respiratory tract disease in adults aged 60 and older, as well as those aged 50 to 59 who are at increased risk of complications.

The shot is not approved for use in pregnant individuals.

FDA Expands Access To RSV Protection

Sanjay Gurunathan, head of vaccines and infectious diseases research and development at GSK, said the broader age indication addresses an unmet medical need among younger adults with underlying health conditions.

He added that expanding eligibility for the vaccine could help protect people vulnerable to severe RSV disease while also easing pressure on healthcare systems.

In the fourth quarter, Arexvy sales reached 198 million pounds, up 25%.

GSK’s fourth quarter vaccine sales edged 4% higher (+4% cc) to 2.29 billion pounds. The increase was driven by strong ex-U.S. demand for Shingrix, Arexvy, and Meningitis vaccines.

RSV Burden Among Younger Adults

RSV continues to place a notable healthcare burden on adults aged 18 to 49 in the U.S., with an estimated 17,000 hospitalizations each year.

The virus also leads to roughly 277,000 emergency department visits and nearly 1.97 million outpatient consultations annually.

Most hospitalizations in this age group occur in people with chronic health conditions that increase the risk of severe disease. These include cardiopulmonary disorders, kidney disease, obesity, and diabetes.

In February, GSK shared new effectiveness data for AREXVY, an RSV vaccine, at the conference.

For GSK's RSV vaccine, the study showed an association with 75.6% vaccine effectiveness (VE) against RSV-related hospitalization at a median follow-up of 5.6 months (maximum 9.7 months) post-vaccination.

Trial Data Supported FDA Decision

The regulatory decision was backed by results from a Phase 3b study that showed the vaccine produced an immune response in adults aged 18 to 49 that was non-inferior to the response observed in adults aged 60 and older.

Efficacy for the vaccine had previously been demonstrated in an earlier Phase 3 trial.

Safety findings in the latest study aligned with earlier data supporting the vaccine's initial approval.

Broader Global Rollout Strategy

GSK said it continues to pursue regulatory submissions for the RSV vaccine in multiple regions as part of efforts to expand access and support long-term growth for the product.

GSK Price Action: GSK stock is up 0.24% at $54.41 at the time of publication on Friday, according to Benzinga Pro data.

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