RSV

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AREXVY is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.1

Vaccination may not protect all recipients.1

RSV

STOPS HERE

AREXVY is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.1

Vaccination may not protect all recipients.1

Primary Endpoint

82.6%


Overall Efficacy Against RSV-LRTD1

(96.95% CI, 57.9, 94.1)

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

Secondary Endpoint

94.6%


Efficacy Against RSV-LRTD in Participants
With at Least 1 Comorbidity1*

(95% CI, 65.9, 99.9)

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

Study Design1:

Study 1, an ongoing, phase 3, randomized, placebo-controlled, observer-blind study in adults aged ≥60 years, evaluated the efficacy of AREXVY in preventing RSV-LRTD during the first season. Participants in the primary population for efficacy analysis received 1 dose of AREXVY (n=12,466) or placebo (n=12,494). At the time of this analysis, median follow-up was 6.7 months.

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 DESIGN

    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

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Advisory Committee on Immunization Practices (ACIP) Recommends RSV Vaccination2

The ACIP recommends a single dose of RSV vaccine, including AREXVY, for adults aged 60 years and older, using shared clinical decision-making. Shared clinical decision-making recommendations are individually based and informed by a decision process between the healthcare provider and the patient.2,3

Vaccinating with AREXVY is a conversation worth having.

It’s important to start the conversation now about vaccination against RSV with your appropriate patients aged 60 and older.

  • Review RSV and its potential risks for people aged 60 and older, including those with certain comorbidities
  • Discuss the option of vaccination with AREXVY

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RSV Season

In the United States, RSV infections typically occur in the fall and winter, and begin to offset in the spring, though some regions vary4
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Choose AREXVY

Choose AREXVY for appropriate patients
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Efficacy and Safety

Learn more about the clinical study results for adults 60 years and older, including those with certain comorbidities
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