What is Arexvy Used For?
Arexvy is a respiratory syncytial virus (RSV) vaccine used to prevent RSV-associated lower respiratory tract disease in adults aged 60 years and older. 1
Primary Indication
Arexvy (RSVPreF3) is specifically approved by the FDA for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) in adults aged ≥60 years. 1 This includes protection against symptomatic RSV infections that affect the lungs, such as pneumonia and bronchitis, which can lead to hospitalization and death in older adults. 1
Current CDC Recommendations for Use
The Advisory Committee on Immunization Practices (ACIP) issued updated recommendations in June 2024 that specify who should receive Arexvy:
Universal Recommendation
- All adults aged ≥75 years should receive a single dose of RSV vaccine (including Arexvy), regardless of health status or comorbidities. 1, 2 This age group experiences markedly higher rates of RSV-related hospitalization, severe disease, and mortality. 2
Risk-Based Recommendation for Younger Adults
- Adults aged 60-74 years should receive Arexvy only if they have at least one qualifying risk factor for severe RSV disease. 1, 2 This risk-based approach reflects postlicensure safety data indicating a possible Guillain-Barré syndrome signal with protein subunit vaccines like Arexvy. 1, 2
Expanded Indication for High-Risk Younger Adults
- Adults aged 50-59 years with risk factors may receive Arexvy, as it is the only RSV vaccine approved for this younger age group. 2 However, ACIP has not issued a formal recommendation for this population due to limited evidence. 2
Qualifying Risk Factors (Ages 60-74 Years)
Adults in the 60-74 age range should receive Arexvy if they have any of the following conditions:
Respiratory conditions: 2
- Chronic obstructive pulmonary disease (COPD)
- Asthma
- Bronchiectasis
- Interstitial lung disease
- Cystic fibrosis
Cardiovascular conditions: 2
- Chronic heart failure
- Coronary artery disease
- Congenital heart disease (isolated hypertension does NOT qualify)
Metabolic and renal conditions: 2
- End-stage renal disease or dialysis dependence
- Diabetes with complications (insulin requirement or end-organ damage)
Neurologic/neuromuscular conditions: 2
- Conditions impairing airway clearance or respiratory muscle strength
- Post-stroke dysphagia
- Amyotrophic lateral sclerosis
- Muscular dystrophy
Other chronic conditions: 2
- Cirrhosis or chronic liver disease
- Severe obesity (BMI ≥40 kg/m²)
- Sickle cell disease or thalassemia
Immunocompromise: 2
- Moderate or severe immunosuppression
- Solid organ or hematopoietic stem cell transplant
- Malignancy
- Immunosuppressive medications
Living situation/functional status: 2
- Residence in nursing homes or long-term care facilities
- Frailty (≥3 Fried criteria)
- Dementia
Dosing and Administration
Single lifetime dose: Only one dose of Arexvy is recommended for a lifetime; individuals who have already received any RSV vaccine should not receive another dose. 2 This single dose provides protection for at least two consecutive RSV seasons. 2
Optimal timing: Vaccination should ideally occur in late summer or early fall (August-October in most of the continental United States) to align with the onset of RSV season and maximize benefit. 2 However, eligible adults may be vaccinated at any time of year. 2
Co-administration: Arexvy can be safely co-administered with seasonal influenza vaccine at different injection sites. 2, 3 Data on simultaneous administration with pneumococcal, herpes zoster, or COVID-19 vaccines are currently lacking. 2
Clinical Efficacy
Arexvy demonstrates strong efficacy in preventing RSV disease:
- 82.6% efficacy against RSV-associated lower respiratory tract disease in the first season 2
- 94.1% efficacy against severe RSV disease in the first season 2
- Sustained protection: Cumulative efficacy of 62.9% against RSV-LRTD over three seasons 2
The vaccine maintains clinically meaningful efficacy even as protection decreases over time, which is expected for a virus characterized by short-term natural immunity. 4
Important Safety Considerations
Guillain-Barré Syndrome (GBS) risk: Postlicensure surveillance has identified a potential increased risk of GBS following Arexvy vaccination. 1, 2 A self-controlled case series showed higher GBS incidence during days 1-42 post-vaccination compared with days 43-90. 2 Patients should be informed of this possible risk as part of shared decision-making. 2
Risk-benefit analysis: Despite the GBS signal, modeling studies demonstrate that the number of preventable RSV-related hospitalizations, ICU admissions, and deaths in high-risk populations exceeds the estimated vaccine-attributable GBS cases. 1, 2 For adults ≥75 years and adults 60-74 years with qualifying risk factors, benefits substantially outweigh risks. 2
Common adverse effects: Injection-site pain, myalgia, fatigue, and headache are the most frequently reported side effects. 2, 4
Clinical Implementation
Patient attestation is sufficient: Healthcare providers should not require extensive medical documentation of risk factors; patient self-attestation alone is adequate evidence. 2 This approach facilitates vaccination access, particularly in remote or underserved settings. 2
Provider flexibility: Qualified vaccinators (pharmacists, nurse practitioners, etc.) may determine eligibility based on clinical assessment and may offer the vaccine to patients they judge to be at increased risk even if not explicitly listed in a category. 2
Priority when supply is limited: If vaccine supply is constrained, prioritize adults ≥75 years, followed by adults with multiple comorbidities, and then residents of long-term care facilities. 2
Common Pitfalls to Avoid
- Do not administer more than one RSV vaccine dose: A single lifetime dose is sufficient; repeat vaccination is not recommended. 2, 3
- Do not withhold vaccination from adults ≥75 years: Age alone is adequate indication; do not delay while waiting for documentation of risk factors. 2
- Do not ignore the GBS risk discussion: Patients receiving Arexvy should be counseled about the possible GBS risk as part of informed consent. 2
- Do not assume prior RSV infection provides lasting immunity: Previous RSV infection does not confer long-lasting protection and does not contraindicate vaccination. 2