RSV VACCINE INJ,SUSP
Clinical Criteria Summary
Indication & Target Population
- Prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.
- ACIP recommends administration for adults ≥ 75 years of age or those aged 60–74 years with one or more risk factors for severe RSV.
Patient Selection Criteria & Risk Factors
- Risk factors for severe RSV include:
- Chronic lung disease (asthma, COPD, interstitial lung disease)
- Chronic cardiovascular disease (e.g., CHF or coronary artery disease, excluding isolated hypertension)
- Moderate/severe immunocompromise
- Diabetes mellitus with end organ damage (e.g., neuropathy, retinopathy, or requiring insulin or SGLT2 inhibitor)
- Neurologic or neuromuscular condition impairing airway clearance or causing respiratory muscle weakness (e.g., poststroke aphasia, amyotrophic lateral sclerosis)
- Advanced chronic kidney disease or liver disease (e.g., cirrhosis)
- Hematologic disorders (e.g., sickle cell disease or thalassemia)
- Severe obesity (BMI ≥ 40 kg/m2)
- Residence in a nursing home or other long-term care facility
- Frailty
- Advanced age
- Other underlying conditions determined by a healthcare provider to increase severe RSV risk
- Clinical trial exclusions included clinically unstable comorbidities, immunocompromise, and history of myocarditis or pericarditis within 2 months prior to screening.
- Efficacy in patients with multiple comorbidities, immunocompromised states, or frailty remains unknown/unclear.
Contraindications & Precautions
- Contraindicated in patients with a history of severe allergic reaction to any component of MRESVIA.
- Requires prevention and management of allergic reactions and syncope following administration.
- Immunocompromised individuals may have a diminished immune response.
Dosing & Administration
- Single intramuscular dose.
- Supplied as a single-dose prefilled syringe containing frozen suspension; must be thawed prior to administration.
Co-administration Guidelines
- Co-administration with other adult vaccines during the same visit is acceptable (including seasonal influenza, COVID-19, pneumococcal, Td/Tdap, and recombinant zoster).
- Clinical data for co-administration is currently only available for influenza vaccines; co-administration may increase local or systemic reactogenicity.