RSV VACCINE INJ,LYPHL
Clinical Criteria Summary
Document 475
Indication & Eligibility
- Prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older
- Indicated for immunocompetent patients aged ≥60 years; patients with pre-existing chronic conditions may be included if medically stable
Dosing & Administration
- Single intramuscular dose (0.5 mL) of lyophilized antigen with adjuvant suspension
- Revaccination at 12 months does not confer additional protection over a single dose
Contraindications & Warnings/Precautions
- Contraindicated in patients with a history of severe allergic reaction to AREXVY or any component of the product
- Appropriate treatment must be available for management of possible anaphylactic reactions or syncope
- Immunocompromised persons may have a diminished response
Safety & Adverse Reactions
- Solicited adverse events include injection site pain, fatigue, myalgia, headache, and arthralgia
- Severe reactogenicity events (Grade 3) occurred in 3.8% of vaccine recipients vs 0.9% of placebo
- Inflammatory neurologic events reported (1 case of Guillain-Barre syndrome, 2 cases of acute disseminated encephalomyelitis/transverse myelitis)
- Numeric imbalance in atrial fibrillation within 30 days postvaccination observed
- Trend towards higher reactogenicity when co-administered with high-dose or adjuvanted influenza vaccine
Clinical Guidance & Recommendations
- FDA approved for ≥60 years of age as a single dose
- ACIP recommends adults ≥60 years may receive a single dose based on shared clinical decision making (SDCM) between patient and provider
- Co-administration with other adult vaccines during the same visit is acceptable, though data is limited to influenza vaccines; co-administration with other adjuvanted or reactogenic vaccines may increase local or systemic reactogenicity
- Efficacy in highest-risk populations (immunocompromised, frail, multiple comorbidities) and benefit on hospitalization or death remain unknown; more post-marketing surveillance data is needed
Risk Factors for Severe Disease & Benefit Considerations
- Decision to vaccinate should consider individual risk for disease, characteristics/values/preferences, provider clinical discretion, and vaccine characteristics
- Those most likely to benefit include individuals with chronic medical conditions: chronic lung disease (asthma or COPD), cardiovascular disease (CHF or coronary artery disease), moderate/severe immunocompromise, diabetes mellitus, neurologic or neuromuscular condition, kidney or liver disease, hematologic disorders
- Additional risk factors include residence in a nursing home or other long-term care facility, frailty, advanced age, and other underlying conditions determined by a healthcare provider to increase severe RSV risk
Document 476
Indication & Target Population
- Prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older.
- ACIP recommends a single dose for adults ≥60 years based on shared clinical decision making.
Eligibility & Exclusions
- Target population: Immunocompetent patients (healthy or with stable chronic conditions) aged ≥60 years.
- Trial exclusions: End stage renal disease, unstable cardiac disease, and conditions associated with risk of prolonged bleeding.
- Efficacy in highest risk populations (multiple comorbidities, immunocompromised, frail) is unknown as they were not included or underrepresented in clinical trials.
Contraindications & Warnings/Precautions
- Contraindicated in patients with a history of severe allergic reaction to ABRYSVO or any component of the product.
- Requires prevention and management of allergic reactions and syncope following administration.
- Immunocompromised individuals may have a diminished immune response.
Dosing & Administration
- Single intramuscular injection (0.5 mL) of lyophilized antigen reconstituted with Sterile Water Diluent.
Co-administration Guidelines
- Co-administration with influenza vaccine is acceptable and met non-inferiority criteria, though titers were somewhat lower.
- Co-administration with other adult vaccines during the same visit is acceptable, but data is only available for flu vaccines; administering with other vaccines may increase local or systemic reactogenicity.
Clinical Decision-Making & Risk Assessment
- Vaccination decision should be guided by shared clinical decision making between patient and provider.
- Consideration of individual risk for severe RSV disease, characteristics/values/preferences, provider clinical discretion, and vaccine characteristics.
- Factors increasing likelihood of benefit include: chronic lung disease (asthma or COPD), cardiovascular disease (CHF or coronary artery disease), moderate/severe immunocompromise, diabetes mellitus, neurologic or neuromuscular condition, kidney or liver disease, hematologic disorders, residence in a nursing home or long-term care facility, frailty, advanced age, and other underlying conditions determined by a healthcare provider to increase severe RSV risk.
- Post-marketing surveillance is recommended for potential immune-mediated diseases (e.g., Guillain-Barre syndrome) and atrial fibrillation.