RSV

STOPS HERE

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:

  • individuals 60 years of age and older;
  • individuals 50 through 59 years of age who are at increased
    risk for LRTD caused by RSV.

Vaccination may not protect all recipients.1

See the immunobridging Study

RSV

STOPS HERE

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in1:

  • individuals 60 years of age and older;
  • individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.

Vaccination may not protect all recipients.1

See the immunobridging Study

STUDY 1

Primary Endpoint

82.6%

Overall Efficacy Against RSV-LRTD in
Participants 60 Years of Age and Older1

(96.95% CI, 57.9, 94.1)

AREXVY (7 cases out of 12,466),
placebo (40 cases out of 12,494)

At the time of this analysis, median follow-up was 6.7 months.

STUDY 1

Secondary Endpoint

94.6%

Efficacy Against RSV-LRTD in
Participants 60 Years of Age and Older
With at Least 1 Comorbidity1*

(95% CI, 65.9, 99.9)

AREXVY (1 case out of 4937),
placebo (18 cases out of 4861)

At the time of this analysis, median follow-up was 6.7 months.

Study 1 Design1:

Study 1, an ongoing, phase 3, randomized, placebo-controlled, observer-blind study in individuals aged ≥60 years, evaluated the efficacy of AREXVY in preventing RSV-LRTD during the first season with follow-up planned for up to 36 months. Participants in the primary population for efficacy analysis received 1 dose of AREXVY (n=12,466) or placebo (n=12,494).

LRTD was defined as ≥2 lower respiratory symptoms/signs, including ≥1 lower respiratory sign for at least 24 hours, or ≥3 lower respiratory symptoms for at least 24 hours.

COMORBIDITIES OF INTEREST:

Chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced liver or renal disease.

  • STUDY 1 DESIGNSUP1

    The efficacy of AREXVY against respiratory syncytial virus-associated lower respiratory tract disease (RSV-LRTD) was evaluated in an ongoing, phase 3, randomized, placebo-controlled, observer-blind study in adults aged 60 years and older in 17 countries from Northern and Southern Hemispheres. The primary population for efficacy analysis (referred to as the modified exposed set) included adults aged 60 years and older receiving 1 dose of AREXVY or placebo and who did not report an RSV-confirmed acute respiratory illness (ARI) prior to Day 15 after vaccination. Participants received 1 dose of AREXVY (n=12,466) or placebo (n=12,494). At the time of the primary efficacy analysis, participants had been followed for the development of RSV-associated LRTD for up to 10 months (median of 6.7 months). At the time of first efficacy analysis, the median age of participants was 69 years. At baseline, 39.3% of participants had at least 1 comorbidity of interest. Participants with pre-existing, chronic, stable disease such as diabetes, hypertension, or cardiac disease were allowed to participate in the study if considered by the investigator as medically stable at the time of vaccination. Immunocompromised participants were excluded.

    The primary objective was to demonstrate the efficacy of AREXVY in the prevention of a first episode of confirmed RSV-A and/or B-associated LRTD during the first season. Confirmed RSV cases were determined by quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) on a nasopharyngeal swab during all ARI episodes.

    ARI was defined by the presence of at least 2 respiratory symptoms/signs for at least 24 hours (nasal congestion, sore throat, lower respiratory symptoms/signs), or at least 1 respiratory symptom/sign plus 1 systemic symptom/sign (fever or feverishness, fatigue, body aches, headache, decreased appetite) for at least 24 hours.

    LRTD was defined as at least 2 lower respiratory symptoms/signs, including at least 1 lower respiratory sign for at least 24 hours, or at least 3 lower respiratory symptoms for at least 24 hours. Lower respiratory symptoms included: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, crackles/rhonchi, respiratory rate ≥20 respirations/min, low or decreased oxygen saturation (O2 saturation <95% or ≤90% if baseline is <95%), and need for oxygen supplementation.1

VIEW DEMONSTRATED SAFETY PROFILE

The CDC Updates RSV Vaccine Recommendation2

The CDC recommends
  • Adults 75 years of age and older receive a single dose of RSV vaccine
  • Adults 60-74 years of age who are at increased risk of severe RSV disease receive a single dose of RSV vaccine
Additional information from the CDC

Eligible adults are currently recommended to receive a single dose of RSV vaccine; adults who have already received RSV vaccination should not receive another dose. Eligible adults may be vaccinated at any time of year, but vaccination will have the most benefit if administered in late summer or early fall, just before the RSV season.3

These recommendations replace the June 2023 shared clinical decision-making recommendation for RSV vaccination for adults aged ≥60 years. Based on currently available evidence, ACIP concluded that the benefits of RSV vaccination did not clearly outweigh the potential harms in adults aged 60-74 years without risk factors for severe RSV disease.3

List of CDC-Identified Risk Factors for Severe RSV Disease3

  • SEE THE LIST

    Qualified vaccinators, including pharmacists, nurse practitioners, and other providers (based on state and jurisdictional law) may determine patient eligibility for RSV vaccination based on clinical assessment even in the absence of medical documentation of a named risk condition. Patient attestation is sufficient evidence of the presence of a risk factor; vaccinators should not deny RSV vaccination to a person because of lack of documentation.3

    • Chronic cardiovascular disease (eg, heart failure, coronary artery disease, or congenital heart disease [excluding isolated hypertension])
    • Chronic lung or respiratory disease (eg, chronic obstructive pulmonary disease, emphysema, asthma, interstitial lung disease, or cystic fibrosis)
    • End-stage renal disease or dependence on hemodialysis or other renal replacement therapy
    • Diabetes mellitus complicated by chronic kidney disease, neuropathy, retinopathy, or other end-organ damage, or requiring treatment with insulin or sodium-glucose cotransporter-2 (SGLT2) inhibitor
    • Neurologic or neuromuscular conditions causing impaired airway clearance or respiratory muscle weakness (eg, poststroke dysphagia, amyotrophic lateral sclerosis, or muscular dystrophy [excluding history of stroke without impaired airway clearance])
    • Chronic liver disease (eg, cirrhosis)
    • Chronic hematologic conditions (eg, sickle cell disease or thalassemia)
    • Severe obesity (body mass index ≥40 kg/m2)
    • Moderate or severe immune compromise
    • Residence in a nursing home
    • Other chronic medical conditions or risk factors that a healthcare provider determines would increase the risk for severe disease due to viral respiratory infection (eg, frailty,* situations in which healthcare providers have concern for presence of undiagnosed chronic medical conditions, or residence in a remote or rural community where transportation of patients with severe RSV disease for escalation of medical care is challenging†)

    *Frailty is a multidimensional geriatric syndrome that reflects a state of increased vulnerability to adverse health outcomes. Although no consensus definition exists, one frequently used tool for determination is the Fried frailty phenotype assessment in which frailty is defined as a clinical syndrome with 3 or more of the following symptoms present: unintentional weight loss (10 lbs [4.5 kg] in the past year), self-reported exhaustion, weakness (grip strength), slow walking speed, or low physical activity.

    †Healthcare providers caring for adults aged 60-74 years residing in these communities may use clinical judgement, knowledge of local RSV epidemiology, and community incidence of RSV-associated hospitalization to recommend vaccination for a broader population in this age group.

    Data on the safety and efficacy of AREXVY in individuals with these risk factors for severe RSV disease as described by CDC may be limited.1

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AREXVY is the first RSV vaccine approved for patients 50-59 years of age who are at increased risk† for RSV-LRTD1

†Medical conditions defined as1: chronic pulmonary disease, chronic cardiovascular disease, diabetes, chronic liver disease, or chronic kidney disease.

The immunobridging criteria were met in the comparison of adults 50 to 59 years of age with increased risk for RSV-LRTD to adults 60 years of age and older.1

Study 4-Immunobridging

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#1 in RSV vaccine doses administered to
adults 60 years and older 4‡

Over 7 million adults 60 years and older vaccinated against RSV-LRTD with AREXVY as of June 20244§

‡Retail claims July 2023-June 2024; retail making up majority of RSV market.4

§Based on data of total retail pharmacy prescriptions in the US from July 2023 through June 2024, showing 7.48 million prescriptions for AREXVY.4

Vaccinating with AREXVY is a conversation worth having

It’s important to start the conversation now about AREXVY with your appropriate unvaccinated patients.

  • Review RSV and its potential risks
  • Discuss the option of vaccination with AREXVY

START THE CONVERSATION

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Efficacy and Safety

Learn more about the clinical study results

LEARN ABOUT EFFICACY

LEARN ABOUT SAFETY

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