The U.S. Food and Drug Administration (FDA) has expanded the approved use of the respiratory syncytial virus (RSV) vaccine Arexvy, developed by British drugmaker GSK, to include adults aged 18 to 49 who are at increased risk of lower respiratory tract disease caused by the virus.
Arexvy had previously been authorized in the United States for the prevention of RSV-related illness in adults aged 60 and older. The vaccine was later cleared for adults aged 50 to 59 who face a heightened risk of severe disease. With the latest regulatory decision, the eligible population now includes younger adults who have medical conditions or other factors that make them more vulnerable to complications from RSV infection.
RSV is a common respiratory virus responsible for seasonal infections similar to influenza. It can lead to severe respiratory illness, including pneumonia, and is a major cause of hospitalization and death among infants and older adults. According to the company, about 21 million adults in the United States under the age of 50 have at least one risk factor that could increase the likelihood of serious RSV illness.
GSK stated that roughly 17,000 people between the ages of 18 and 49 are hospitalized for RSV each year in the United States. Most of those hospitalizations occur among individuals with chronic health conditions that increase the risk of severe infection.
The FDA’s decision places GSK in the same regulatory position as other vaccine manufacturers that already secured approval for RSV vaccines in this younger at-risk population. Moderna obtained authorization for its RSV vaccine mRESVIA for the 18–49 age group in 2024, while Pfizer received approval for its vaccine Abrysvo in 2025. All three vaccines were initially cleared for use in adults aged 60 and older before their indications were broadened.
GSK first expanded Arexvy’s eligibility in June 2024 when regulators allowed its use in adults aged 50 and above who face an elevated risk. Pfizer later secured a similar expansion for its vaccine several months afterward. The most recent authorization for adults aged 18 to 49 extends the vaccine’s potential reach further.
Sanjay Gurunathan, head of vaccines research and development at GSK, commented on the decision, stating, “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.”
Despite the FDA approval, the vaccine cannot yet be provided to individuals in the newly authorized age group. Before distribution begins, the U.S. Centers for Disease Control and Prevention (CDC) must issue its own recommendation for the vaccine’s use. Historically, CDC guidance has often followed regulatory approvals, but some recent decisions have shown greater variability.
For example, in 2024, the CDC adopted a recommendation from its Advisory Committee on Immunization Practices (ACIP) to limit its endorsement of RSV vaccination to adults aged 60 to 74 who are considered at risk. The CDC has also made adjustments to other immunization policies. In December, the agency revised the U.S. childhood immunization schedule by removing six previously recommended shots. Additionally, RSV immunization for infants is now restricted to high-risk children and those whose mothers were not vaccinated.
The FDA’s expansion also aligns U.S. policy more closely with regulatory decisions in Europe. In December, a committee of the European Medicines Agency supported the use of Arexvy for all adults aged 18 and older, and European regulators formally approved the broader use in January.
Since its launch, sales of Arexvy have fluctuated. GSK reported global revenue of 1.2 billion pounds (about $1.49 billion) from the vaccine in 2023, its first year on the market. Sales later declined to 593 million pounds ($757 million) in 2024 and 590 million pounds ($777 million) the following year. During the same period, Pfizer’s RSV vaccine Abrysvo recorded an increase in sales from $755 million in 2024 to $1.03 billion the following year.
Overview of Arexvy Approval Expansion
Arexvy has received expanded approval from the U.S. FDA, allowing its use in adults aged 18 to 49 who are at increased risk of respiratory syncytial virus (RSV) disease. This milestone significantly broadens the reach of Arexvy, which was previously approved for older populations. The updated approval enables Arexvy to protect a wider group of vulnerable individuals from severe respiratory complications.
What This Means for At-Risk Adults
The expanded indication of Arexvy focuses on younger adults with underlying health conditions that increase the risk of severe RSV infection. With this decision, Arexvy becomes an important preventive option for individuals who may experience serious outcomes such as pneumonia or hospitalization. This move positions Arexvy as a key vaccine in addressing RSV across multiple age groups.
