Can mRESVIA be Given When RSVPreF3 is Not Available?
Yes, mRESVIA (mRNA-1345) is an appropriate alternative RSV vaccine for this 56-year-old patient with Huntington's disease and dysphagia when RSVPreF3 is unavailable. 1, 2
Rationale for mRESVIA Use in This Patient
Age and Risk Factor Qualification
- This patient qualifies for RSV vaccination based on age (56 years) and neurologic disease. Adults aged 50-59 years with neurologic/neuromuscular conditions affecting airway clearance are at increased risk for severe RSV disease and should receive vaccination. 2, 3
- Huntington's disease with dysphagia represents a chronic neurological condition that impairs airway clearance, placing this patient at substantially elevated risk for RSV-related lower respiratory tract disease. 2, 4
Vaccine Selection When RSVPreF3 is Unavailable
- While RSVPreF3 (Arexvy) is the only vaccine specifically FDA-approved for adults aged 50-59 years with risk factors 2, 3, mRESVIA is approved for adults ≥60 years and can be considered off-label for high-risk adults aged 50-59 years when the preferred vaccine is unavailable. 1, 2, 5
- mRESVIA demonstrated 78.7% efficacy against RSV-associated lower respiratory tract disease with ≥2 symptoms during the primary analysis period (median 3.7 months follow-up), and 80.9% efficacy against disease with ≥3 symptoms. 1
- Over extended follow-up (median 18.8 months), efficacy remained at 47.4% for disease with ≥2 symptoms and 48.4% for disease with ≥3 symptoms, demonstrating sustained protection. 1
Safety Profile of mRESVIA
Reactogenicity and Adverse Events
- mRESVIA is more reactogenic than placebo (pooled relative risk = 1.54 [95% CI = 1.40–1.68]), with injection-site pain and fatigue being the most common solicited adverse events. 1
- The pooled relative risk for serious adverse events was 1.00 (95% CI = 0.95–1.05), indicating no increased risk of serious complications compared to placebo. 1
- Importantly, no cases of Guillain-Barré syndrome, other inflammatory neurologic events, myocarditis, or pericarditis were recorded within 42 days after mRESVIA vaccination. 1
Special Consideration for Neurologic Disease
- The absence of inflammatory neurologic adverse events in clinical trials is particularly reassuring for this patient with pre-existing Huntington's disease. 1
- Dysphagia itself is not a contraindication to intramuscular vaccination. 2, 3
Administration Guidelines
Timing and Dosing
- Administer a single dose of mRESVIA intramuscularly, preferably between September and November to maximize protection during peak RSV season. 1, 2, 3
- Only one lifetime dose is currently recommended; no booster doses are indicated at this time. 2, 3
Co-administration Considerations
- mRESVIA can be co-administered with seasonal influenza vaccine at different injection sites, though numerically lower antibody titers for both vaccines may occur (clinical significance unknown). 1, 2
- Co-administration with COVID-19 vaccines has not been studied and should be avoided until more data are available. 1
Important Clinical Caveats
Documentation Requirements
- Patient attestation of risk factors (Huntington's disease with dysphagia) is sufficient evidence; extensive medical documentation should not be required to avoid barriers to vaccination. 2, 3
Priority Justification
- This patient should be prioritized for vaccination given the combination of neurologic disease affecting airway clearance and the increased risk of aspiration pneumonia associated with dysphagia. 2, 4
- Previous RSV infection (if any) does not confer long-lasting immunity and does not contraindicate vaccination. 2, 3