What are the available Respiratory Syncytial Virus (RSV) vaccines for a senior patient with underlying health conditions and compromised immune system?

Available RSV Vaccines for Senior Patients with Underlying Conditions

Three RSV vaccines are currently available for older adults: RSVPreF3 (Arexvy), RSVpreF (Abrysvo), and mRNA-1345 (mRESVIA), all demonstrating high efficacy in preventing RSV-associated lower respiratory tract disease in seniors with chronic medical conditions and immunocompromise. 1, 2

Approved Vaccine Products

RSVPreF3 (Arexvy - GSK)

• Approved for adults ≥50 years of age with risk factors and all adults ≥60 years 3, 4
• This is an AS01E-adjuvanted recombinant protein subunit vaccine containing RSV prefusion F protein 5, 6
• Demonstrates 82.6% efficacy against RSV-associated lower respiratory tract disease and 94.1% efficacy against severe disease in the first season 3, 5
• Maintains efficacy for at least three consecutive RSV seasons with cumulative efficacy of 62.9% over three years 1, 3
• The only vaccine currently approved for adults aged 50-59 years with risk factors 3, 4

RSVpreF (Abrysvo - Pfizer)

• Approved for adults ≥60 years of age 3, 4
• This is a bivalent recombinant protein subunit vaccine 6
• Shows 88.9% efficacy against RSV-associated lower respiratory tract disease with ≥3 symptoms in the first season 3
• Maintains protection for at least two seasons with cumulative efficacy of 58.8% (≥2 symptoms) and 81.5% (≥3 symptoms) 1, 3

mRNA-1345 (mRESVIA - Moderna)

• Approved for adults ≥60 years of age 2, 7
• This is an mRNA-based vaccine 1
• Demonstrates 83.7% efficacy against RSV-associated lower respiratory tract disease after median follow-up of 3.7 months 1
• Efficacy of 63.3% maintained at 8.6 months follow-up 1
• Available in Europe and recently approved in the United States 3, 2

Vaccine Characteristics Critical for Immunocompromised Patients

All three approved RSV vaccines are non-live, recombinant formulations that cannot replicate in the human body, making them safe for immunocompromised patients including those with cancer, on immunosuppressive therapy, or with compromised immune systems. 4

• These are completely inactivated vaccines containing no live viral particles 4
• No special precautions regarding live vaccine administration apply 4
• Can be safely administered to patients with cancer, those on immunosuppressive therapy, and elderly patients with multiple comorbidities 4

Efficacy in High-Risk Populations

Patients with Chronic Medical Conditions

• RSVPreF3 demonstrates 92.1% efficacy in participants with cardiorespiratory conditions (COPD, asthma, chronic heart failure) over one season and 73.8% over two seasons 1, 8
• 100% efficacy in participants with endocrine/metabolic conditions (diabetes, advanced renal or liver disease) over one season and 63.1% over two seasons 1, 8
• 94.6% efficacy in participants with ≥1 condition of interest and 92.0% in those with ≥2 conditions 8

Immunocompromised Patients

• Post-licensure data shows 73% effectiveness against RSV-associated hospitalization in adults ≥60 years with immunocompromising conditions 1
• 83% effectiveness in patients with end-stage renal disease who have additional immunocompromise 1
• Postvaccination neutralizing antibody titers are at least as high in participants with underlying conditions as in those without 8

Real-World Effectiveness

• Vaccine effectiveness against RSV-associated hospitalization ranges from 75% to 82% across all vaccine products in adults ≥60 years during the first season 1
• High effectiveness demonstrated against RSV-associated emergency department visits and critical illness (ICU admission and/or death) 1

Administration Guidelines

Dosing Schedule

• A single lifetime dose is currently recommended for all three vaccines 3, 4, 9
• Adults who have previously received any RSV vaccine should not receive another dose 3, 9
• Protection lasts for at least two consecutive RSV seasons, with RSVPreF3 showing protection through three seasons 1, 3

Optimal Timing

• Preferably administer between September and November (or August-October), before or early in the RSV season 3, 4, 9
• Eligible adults who have not been vaccinated may receive the vaccine at any time of year 3

Co-Administration

• Can be co-administered with seasonal influenza vaccine at different injection sites 3, 4, 9
• Some studies show numerically lower antibody titers for both RSV and influenza when co-administered, though clinical significance remains unknown 4
• Data on co-administration with pneumococcal, herpes zoster, and COVID-19 vaccines are currently lacking 9

Safety Profile

Common Adverse Events

• Most adverse events are transient and mild to moderate in severity 1
• Injection-site pain and fatigue are the most common adverse events reported 1, 2, 6
• Other common reactions include myalgia, headaches, injection site redness and swelling 2, 6

Serious Safety Considerations

• Postlicensure surveillance has identified a potential increased risk of Guillain-Barré syndrome following protein subunit RSV vaccination (Arexvy and Abrysvo) 3
• Frequency of serious adverse events was similar between vaccine (4.4%) and placebo (4.3%) groups in clinical trials 1
• Atrial fibrillation was reported as an unsolicited event in 0.1% of RSVPreF3 recipients versus <0.1% of placebo recipients 1
• Three cases of inflammatory neurologic events were reported within 42 days after RSVPreF3 vaccination, including 1 case of Guillain-Barré syndrome 1

Risk-Benefit Analysis for High-Risk Patients

• The number of RSV-associated hospitalizations, ICU admissions, and deaths preventable over two RSV seasons per 1 million vaccine doses exceeds the estimated number of potential vaccine-attributable Guillain-Barré syndrome cases 3
• Patients with multiple comorbidities benefit substantially more from vaccination than they are at risk from vaccine-related adverse events 3

Clinical Implementation for Your Patient Population

Who Should Receive RSV Vaccination

• All adults ≥75 years should receive RSV vaccination regardless of health status or comorbidities 3, 4, 9
• Adults 60-74 years with chronic conditions (COPD, asthma, heart failure, coronary artery disease, diabetes, chronic kidney disease, chronic liver disease, immunocompromise) should receive vaccination 3, 4, 9
• Adults 50-59 years with risk factors should receive RSVPreF3 (Arexvy), the only approved vaccine for this age group 3, 4

Documentation Requirements

• Patient attestation alone is sufficient evidence of risk factors; extensive medical documentation should not be required 3, 4, 9
• Adults ≥75 years should not be delayed vaccination while waiting for documentation, as age alone is sufficient indication 3, 9

Prioritization if Supply is Limited

1. Adults ≥75 years (highest priority) 3, 4, 9
2. Adults ≥50 years with multiple comorbidities 3, 9
3. Residents of long-term care facilities 3, 9

Important Clinical Caveats

• Previous RSV infection does not confer long-lasting immunity and does not contraindicate vaccination, as reinfections are common 3, 4, 9
• The burden of RSV in older adults has been underrecognized, accounting for 10.6% of hospitalizations for pneumonia and 11.4% for COPD exacerbations 3, 4
• For cancer patients and severely immunocompromised individuals, while vaccine effectiveness data are limited, consultation with infectious disease specialists is recommended 4
• The need for additional RSV vaccine doses will be evaluated in the future as more data on duration of protection become available 3