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

New patient population

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

New patient population

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 individuals 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 individuals 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

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AREXVY is the first and only RSV vaccine approved for patients aged 50-59 years at increased risk for LRTD caused by RSV1

The immunobridging criteria was 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

Study 4-Immunobridging

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

Over 7 million adults 60 years and older vaccinated against RSV-LRTD with AREXVY as of March 20242‡

†Retail claims July 2023-March 2024; retail making up majority of RSV market.

‡Based on data of total retail pharmacy prescriptions in the US from July 2023 through March 2024, showing 7.07 million prescriptions for AREXVY.2

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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