FDA Expands Approval of Arexvy to Include Adults 18 to 49 Years at Increased Risk of Disease

The FDA expanded the approved age indication for GSK's respiratory syncytial virus (RSV) vaccine (Arexvy) to include adults aged 18 to 49 years who are at an increased risk for lower respiratory tract disease (LRTD). This landmark decision follows previous approvals for adults 60 years and older, as well as those aged 50 to 59 years at increased risk, significantly broadening the population eligible for protection against a virus traditionally associated with infants and the elderly.¹

For pharmacists, this expansion represents a critical opportunity to intervene in a demographic where an estimated 21 million adults under the age of 50 years possess at least 1 risk factor for severe RSV infection, such as asthma, diabetes, or chronic heart disease.

“This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions and help ease pressure on the healthcare system,” Sanjay Gurunathan, head of vaccines and infectious diseases research and development at GSK, said in a news release.

The medical necessity for this expansion is underscored by the annual burden of RSV among younger US adults, which accounts for approximately 17,000 hospitalizations and nearly 2 million outpatient visits. Clinical data supporting the FDA’s decision demonstrated that a single dose of the vaccine elicited a noninferior immune response in high-risk adults aged 18 to 49 years compared to those 60 years and older. The safety profile remained consistent with earlier trials, with common adverse events including injection site pain, fatigue, and headache, although pharmacists should note that Arexvy is specifically not indicated for use in pregnant individuals.

This regulatory update arrives as the broader clinical community moves toward more inclusive vaccination strategies, as evidenced by the CDC's Advisory Committee on Immunization Practices (ACIP) recently voting to expand RSV vaccine recommendations to include all adults aged 50 to 59 years at increased risk. Currently, standard recommendations prioritize individuals 75 years and older, alongside those aged 60 to 74 years with underlying medical conditions such as chronic cardiovascular or lung disease.²

As more vaccines like Pfizer’s Abrysvo and Moderna’s mResvia enter the market with varying indications, pharmacists must remain the frontline experts in navigating these complex, age-based recommendations for their patients.^2,3

Despite the expanding eligibility, significant gaps in patient awareness and vaccine uptake persist, highlighting a pivotal role for community pharmacists. Research indicates that while television commercials and primary care providers are the most influential factors in a patient’s decision to vaccinate, only about 20% of patients report hearing about RSV vaccines from their pharmacist.³

This data suggests that proactive communication and partnerships between pharmacists and local primary care providers are essential for increasing immunization rates. By identifying high-risk individuals during routine prescription counseling and addressing concerns about common side effects like myalgia or arthralgia, pharmacists can bridge the gap between clinical eligibility and actual protection.^1,3

Ultimately, the expansion of Arexvy’s indication into the 18-to-49-year age bracket empowers pharmacists to protect a much younger, yet vulnerable, segment of the population from severe respiratory complications. As the true number of adult RSV cases is often underestimated due to a lack of routine testing, the pharmacist's ability to educate patients on the risks of bronchiolitis and pneumonia is more vital than ever. Through consistent education and collaboration with the broader health care system, the pharmacy profession can help ease the pressure on the health care system and reduce the significant morbidity associated with RSV across all adult age groups.^1-3

READ MORE: Infectious Diseases Resource Center

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REFERENCES

1. GSK’s RSV vaccine, Arexvy, approved in us for expanded age indication in adults aged 18–49 years at increased risk. News release. GSK. March 13, 2026. Accessed March 13, 2026. https://www.businesswire.com/news/home/20260313340226/en/GSKs-RSV-Vaccine-AREXVY-Approved-in-US-for-Expanded-Age-Indication-in-Adults-Aged-1849-Years-at-Increased-Risk

2. Gallagher A. ACIP Votes to Expand RSV Vaccine Recommendation to Include Adults 50 Years and Older. Drug Topics. April 17, 2025. Accessed March 13, 2026. https://www.drugtopics.com/view/acip-votes-to-expand-rsv-vaccine-recommendation-to-include-adults-50-years-and-older

3. Meara K. Pharmacist, Provider Partnership Can Help Increase RSV Vaccine Uptake. Drug Topics. August 12, 2025. Accessed March 13, 2026. https://www.drugtopics.com/view/pharmacist-provider-partnership-can-help-increase-rsv-vaccine-uptake