Arexvy: Indication and Use
Arexvy is prescribed for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years and older. 1, 2
Primary Indication
- Arexvy (RSVPreF3) is a recombinant subunit RSV vaccine approved by the FDA specifically to prevent RSV-related lower respiratory tract illness in older adults. 1, 2
- The vaccine contains recombinant respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation. 1
Target Population and Recommendations
Strongly Recommended Groups
- Adults 75 years of age and older should receive RSV immunization, particularly those with chronic health conditions who are at increased risk of severe RSV disease. 3
- Adults 60 years of age and older who are residents of nursing homes and other chronic care facilities should receive RSV immunization. 3
May Be Considered
- Adults 50 to 74 years of age may consider receiving an RSV vaccine as an individual decision in consultation with their healthcare provider. 3
- Arexvy is authorized for adults 50 years and older, though the strongest recommendations focus on those 60 and above. 3
Clinical Context and Disease Burden
- RSV causes approximately 6,000-10,000 deaths and 60,000-160,000 hospital admissions annually among adults aged 65 years and older in the United States. 2
- Older adults, particularly those with chronic medical conditions, are at higher risk of severe outcomes from RSV infection. 3
- Prior to Arexvy's approval, there was no vaccine or targeted treatment for RSV in older adults, with management limited to supportive care. 2
Efficacy
- Arexvy offers approximately 83% protection against lower respiratory tract illness caused by RSV in adults. 1
- Protection appears to be maintained for up to two RSV seasons based on clinical trial data. 1
- The vaccine demonstrates sustained antibody responses, with neutralizing antibodies remaining elevated for at least six months post-vaccination. 4
Safety Profile
- The vaccine was generally well tolerated in clinical trials. 1
- Most frequently reported adverse events were mild to moderate and included: injection site pain, fatigue, myalgia, headache, and arthralgia. 1
- No serious adverse events were observed in transplant recipient studies. 4
Important Clinical Considerations
- This is the first FDA-approved vaccine to prevent RSV-related lower respiratory tract disease in older adults, representing a significant breakthrough in prevention. 1, 2
- The duration of protection and need for booster doses remain under investigation. 3
- Evidence suggests the vaccine may provide similar reductions in RSV-associated hospitalizations and medically attended RSV respiratory tract infections across the approved age groups. 3