Arexvy Indications
Arexvy (RSVPreF3 OA) is FDA-approved for the prevention of respiratory syncytial virus (RSV)-associated lower respiratory tract disease in adults aged ≥60 years. 1
Primary Indication
The vaccine is specifically indicated for:
- Prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) in adults aged 60 years and older
- Prevention of severe RSV-LRTD requiring hospitalization in this same population 2
Current ACIP Recommendations (2024)
The most recent CDC/ACIP guidance from June 2024 provides specific recommendations for who should receive Arexvy:
Recommended Populations:
- All adults aged ≥75 years (universal recommendation)
- Adults aged 60-74 years at increased risk for severe RSV disease (risk-based recommendation)
Key Restrictions:
- Single dose only - adults who have previously received any RSV vaccine should not receive another dose 1
- Not indicated for pregnant adults - separate recommendations exist for maternal RSV vaccination to protect infants 1
Clinical Context
RSV causes significant morbidity and mortality in older adults, particularly during fall and winter months in the United States. The vaccine demonstrated:
- 82.6% efficacy against RT-PCR-confirmed RSV-LRTD 2
- 94.1% efficacy against severe RSV-LRTD 2
- 71.7% efficacy against RSV-related acute respiratory infection 2
- Effectiveness against both RSV-A and RSV-B subtypes (84.6% and 80.9% respectively for LRTD) 2
Important Caveats
This is a single-dose vaccine - there is currently no recommendation for booster doses, and adults who received RSV vaccine in the 2023-2024 season should not receive another dose 1. The vaccine maintains effectiveness for at least two RSV seasons 3.
The 2024 ACIP update moved away from shared clinical decision-making to more definitive age-based and risk-based recommendations to maximize coverage among those most likely to benefit from vaccination 1.