The US Food and Drug Administration has expanded the approved indication for the respiratory syncytial virus vaccine (adjuvanted), Arexvy, to include adults aged 18 to 49 years who are at increased risk for lower respiratory tract disease caused by respiratory syncytial virus, according to a press release from GSK.
The vaccine had previously been approved in the US for prevention of respiratory syncytial virus (RSV)-related lower respiratory tract disease in adults aged 60 years and older and in adults aged 50 to 59 years who are at increased risk. The vaccine is not indicated for use during pregnancy.
The expanded indication applies to a population with a measurable RSV burden. In the US, an estimated 21 million adults younger than 50 years have at least 1 risk factor associated with severe RSV infection. Among adults aged 18 to 49 years, RSV is estimated to account annually for approximately 17,000 hospitalizations, 277,000 emergency department visits, and nearly 2 million outpatient visits. Most hospitalizations in this age group occur among patients with chronic medical conditions that increase the risk for severe RSV disease, including chronic cardiopulmonary disease, kidney disease, obesity, and diabetes.
The US Food and Drug Administration decision was supported by findings from a phase 3b open-label immunogenicity trial evaluating immune response and safety of the vaccine in adults aged 18 to 49 years at increased risk for RSV-related lower respiratory tract disease compared with adults aged 60 years and older. The trial enrolled 1,458 participants across 52 locations in 6 countries, including 16 sites in the US, and demonstrated a noninferior immune response in the younger high-risk group. Vaccine efficacy had previously been demonstrated in an earlier phase 3 trial.
The safety profile observed in the phase 3b study was consistent with findings from the broader phase 3 clinical development program that supported the vaccine’s initial approval. The most commonly reported adverse events included injection site pain, fatigue, myalgia, headache, and arthralgia within 4 days following vaccination. These events were generally transient and mild to moderate intensity.
RSV is a contagious respiratory virus that affects the lungs and airways and is estimated to infect approximately 64 million people globally each year. Adults with chronic medical conditions, compromised immune function, or advanced age may face increased risk for severe disease. RSV infection may exacerbate conditions such as chronic obstructive pulmonary disease, asthma, and chronic heart failure and may lead to complications including pneumonia, hospitalization, and death.
Arexvy contains recombinant RSV glycoprotein F stabilized in the prefusion conformation combined with the AS01E adjuvant system. According to the company, the vaccine has been approved for adults aged 60 years and older in 70 countries and for adults aged 50 to 59 years at increased risk in more than 60 countries. In the European Economic Area, the vaccine is approved for adults aged 18 years and older.
Source: GSK
