What are the current RSV vaccination recommendations for adults ≥ 60 years and adults 18‑59 years with high‑risk conditions (chronic heart or lung disease, diabetes, obesity, immunocompromise), including vaccine options (Arexvy [glaxial], Abrysvo [pfizer]), dosing schedule, timing, contraindications, and maternal vaccination ≥32 weeks gestation?

RSV Vaccination Recommendations for Adults

All adults aged ≥75 years should receive a single lifetime dose of RSV vaccine, and adults aged 60–74 years should be vaccinated if they have any chronic medical condition or risk factor for severe RSV disease. 1

Age-Based Vaccination Framework

Adults ≥75 Years

• Universal vaccination is recommended regardless of health status or comorbidities due to significantly elevated rates of RSV-associated hospitalization, severe disease, and mortality in this age group. 1
• The 30-day mortality hazard ratio is 2.85 compared to younger adults, and 54.1% of RSV hospitalizations occur in this age group. 2
• Vaccination should not be delayed while waiting for documentation of risk factors—age alone is sufficient indication. 3

Adults Aged 60–74 Years

Vaccination is recommended only if at least one qualifying risk factor is present. 1 This shift from the 2023 shared clinical decision-making approach reflects post-licensure safety surveillance identifying potential Guillain-Barré syndrome (GBS) risk with protein subunit vaccines. 4, 5

Qualifying Risk Factors:

Cardiovascular conditions: 1, 3

• Chronic heart failure
• Coronary artery disease
• Congenital heart disease
• Note: Isolated hypertension does NOT qualify 3

Respiratory conditions: 1, 3

• Chronic obstructive pulmonary disease (COPD)
• Asthma
• Emphysema
• Interstitial lung disease
• Cystic fibrosis
• Bronchiectasis

Metabolic and renal conditions: 1, 3

• End-stage renal disease or dialysis dependence
• Diabetes with complications (requiring insulin, SGLT2 inhibitors, or with end-organ damage such as neuropathy, retinopathy, or chronic kidney disease)

Neurologic/neuromuscular conditions: 3

• Disorders causing impaired airway clearance or respiratory muscle weakness
• Post-stroke dysphagia
• Amyotrophic lateral sclerosis
• Muscular dystrophy
• Note: History of stroke without ongoing airway impairment does NOT qualify 3

Other chronic conditions: 1, 3

• Chronic liver disease (cirrhosis)
• Chronic hematologic disorders (sickle cell disease, thalassemia)
• Severe obesity (BMI ≥40 kg/m²)

Immunocompromise: 1, 3

• Moderate or severe immunocompromise (as defined in COVID-19 vaccination guidance)
• Solid organ or hematopoietic stem cell transplant recipients
• Malignancies
• Immunosuppressive medications

Living situation and functional status: 1, 3

• Nursing home or long-term care facility residence (17.2% of RSV hospitalizations occur in this population) 2
• Frailty (≥3 criteria of the Fried phenotype)
• Dementia

Adults Aged 50–59 Years

• Only RSVPreF3 (Arexvy) is FDA-approved for this age group with qualifying risk factors. 1, 3
• As of June 2024, ACIP has not voted on a recommendation for this age group, citing insufficient evidence on safety, duration of protection, and immunogenicity in immunocompromised patients. 1
• Individual decision-making in consultation with healthcare providers may be considered. 6

Available Vaccines

Three FDA-approved RSV vaccines are acceptable for adults ≥60 years: 1

• Arexvy (GSK) – protein subunit vaccine
• Abrysvo (Pfizer) – protein subunit vaccine
• mResvia (Moderna) – mRNA vaccine

For adults 50–59 years with risk factors, only Arexvy is approved. 1, 3

Dosing Schedule and Timing

Single Lifetime Dose

• Only one dose is recommended for a lifetime; adults who have already received any RSV vaccine should not receive another dose. 1
• A single dose provides protection for at least two consecutive RSV seasons. 1
• The need for additional doses will be evaluated by ACIP as more data on duration of protection become available. 1

Optimal Timing

• Vaccination should preferably occur in late summer or early fall (August–October in most of the continental United States), just before RSV season begins. 1
• Eligible adults may be vaccinated at any time of year, but late summer/early fall administration maximizes benefit. 1

Coadministration

• RSV vaccine may be co-administered with seasonal influenza vaccine at different injection sites. 1
• Data on co-administration with pneumococcal, herpes zoster, and COVID-19 vaccines are currently lacking. 4

Implementation Guidance

Documentation Requirements

• Patient self-attestation of a qualifying risk factor is sufficient; vaccination should not be denied due to lack of formal medical documentation. 1, 3
• Qualified vaccinators (pharmacists, nurse practitioners, other providers per state law) may determine eligibility based on clinical assessment. 1

Provider Flexibility

• Clinicians may offer RSV vaccine to patients they assess as being at increased risk even if the patient does not fall within an explicitly listed category. 1, 3
• This flexibility is particularly important in remote or rural settings where transport is limited. 3

Priority When Supply Is Limited

If vaccine supply is constrained, prioritize in the following order: 4

1. Adults aged ≥75 years
2. Adults aged ≥50 years with multiple comorbidities
3. Residents of long-term care facilities

Safety Considerations

Guillain-Barré Syndrome Risk

• Post-licensure surveillance identified a potential increased risk of GBS following protein subunit RSV vaccines (Arexvy and Abrysvo). 4, 5
• FDA self-controlled case series analysis among Medicare beneficiaries showed increased GBS incidence during days 1–42 post-vaccination compared to days 43–90. 1
• For protein subunit vaccines, patients should be informed of the potential GBS risk. 1
• Despite this signal, modeling demonstrates that the number of preventable RSV-related hospitalizations, ICU admissions, and deaths exceeds estimated vaccine-attributable GBS cases in high-risk populations. 1, 4

Risk-Benefit Analysis

• For adults aged 60–74 years without risk factors, ACIP concluded that benefits did not clearly outweigh potential harms, leading to the risk-based recommendation. 4
• For adults ≥75 years and those 60–74 years with risk factors, benefits substantially outweigh risks. 1, 4

Clinical Outcomes and Disease Burden

Severe Outcomes in Hospitalized Patients

Among adults ≥60 years hospitalized with RSV: 2

• 18.5% experienced severe outcomes
• 17.0% required ICU admission
• 4.8% required mechanical ventilation
• 4.7% died

Cardiovascular Complications

• Acute cardiac events occur in 22.4% of hospitalized RSV patients overall and 33% of those with pre-existing cardiovascular disease. 4
• Heart failure exacerbation during RSV hospitalization independently increases mid- to long-term mortality (adjusted HR 1.86). 4
• Close monitoring for cardiac complications is essential in elderly RSV patients, particularly those with pre-existing cardiovascular disease. 4

Most Common Underlying Conditions

The most prevalent comorbidities among hospitalized RSV patients are: 2

• Obesity
• COPD
• Congestive heart failure
• Diabetes

Vaccine Efficacy

First Season Efficacy

• RSVPreF3 (Arexvy) demonstrates 82.6% efficacy against RSV-associated lower respiratory tract disease and 94.1% efficacy against severe disease in the first season. 4
• RSVpreF (Abrysvo) shows 88.9% efficacy against RSV-associated lower respiratory tract infection with ≥3 symptoms in the first season. 4

Multi-Season Protection

• RSVPreF3 maintains cumulative efficacy of 62.9% over three seasons. 4
• RSVpreF demonstrates cumulative efficacy of 58.8% (≥2 symptoms) and 81.5% (≥3 symptoms) over two seasons. 4
• Despite decreasing efficacy over time, protection remains clinically meaningful compared to placebo. 5

Common Pitfalls to Avoid

1. Do not withhold vaccination from adults ≥75 years while waiting for documentation—age alone qualifies them. 3

2. Do not deny vaccination to adults 60–74 years based on lack of formal medical records—patient attestation is sufficient. 1, 3

3. Do not qualify patients with isolated hypertension alone—cardiovascular qualification requires heart failure, coronary artery disease, or congenital heart disease. 3

4. Do not assume prior RSV infection confers lasting immunity—reinfection is common and does not contraindicate vaccination. 4, 7

5. Do not administer a second dose to previously vaccinated adults—only one lifetime dose is currently recommended. 1

Maternal Vaccination

• Abrysvo (Pfizer) is the only RSV vaccine indicated for use in pregnancy (≥32 weeks gestation) to prevent RSV lower respiratory tract disease in infants from birth to 6 months of age. 5
• This maternal indication is distinct from adult vaccination recommendations. 5

Contraindications and Precautions

• Standard vaccine contraindications apply (severe allergic reaction to vaccine components). 1
• Additional information on contraindications and precautions is available at CDC's RSV vaccination website. 1
• For protein subunit vaccines, inform patients of potential GBS risk as part of shared decision-making. 1