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 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

 

Limitations of Use

AREXVY is not for use in pregnant individuals.

 

Vaccination may not protect all recipients.1

SEE THE IMMUNOBRIDGING STUDIES

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, a phase 3, randomized, placebo-controlled, observer-blind study in individuals aged ≥60 years, evaluated the efficacy of AREXVY in preventing RSV-LRTD for up to 3 RSV seasons. 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 INTEREST1:

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.

    VIEW DEMONSTRATED SAFETY PROFILE

    See the CDC Recommendation for RSV Vaccination in Adults

    Recommendation guidelines for adults 50-74 years of age at increased risk for severe RSV and adults 75+ years of age.

    SEE THE FULL RECOMMENDATION

    Effectiveness in patients 18-59 years of age who are at increased risk for RSV-LRTD1

    Effectiveness of AREXVY in individuals 18 through 49 (Study 7) and 50 through 59 years of age (Study 4) with chronic medical conditions† was assessed by a comparison of RSV neutralizing antibody responses induced by AREXVY in these age groups to antibody responses of individuals 60 years of age and older. The comparisons met the criteria for immunobridging.

     

    Vaccine efficacy in adults 60 years of age and older was demonstrated in Study 1.1

     

    †Medical conditions for individuals 18 through 59 years of age defined as: chronic pulmonary disease, chronic cardiovascular disease, diabetes, chronic liver disease, chronic kidney disease, and, for individuals 18 through 49 years of age, neurological or neuromuscular conditions.1

    IMMUNOBRIDGING STUDIES

    Over 10.2 million adults 60 years and older vaccinated against RSV-LRTD with AREXVY2‡

    ‡Based on data of total retail pharmacy prescriptions in the US from July 2023 through September 2025, showing 10.29 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

    Efficacy and Safety

    Learn more about the clinical study results

    LEARN ABOUT EFFICACY
    LEARN ABOUT SAFETY

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    Indication & Important Safety Info

    Indication

    Important Safety Information

    Indication

    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 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

     

    Limitations of Use

    AREXVY is not for use in pregnant individuals.

    Important Safety Information

    • AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY
    • The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY
    • Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY
    • Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting
    • Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY
    • In adults 60 years of age and older, the most commonly reported adverse reactions (≥10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%)
    • In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%)
    • In adults 18 through 49 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (76.0%), myalgia (59.9%), fatigue (59.6%), headache (43.6%), and arthralgia (28.3%)
    • Vaccination with AREXVY may not result in protection of all vaccine recipients

     

    Please see full Prescribing Information.

    To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or
    1-888-825-5249, or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

    CDC=Centers for Disease Control and Prevention; RSV-LRTD=respiratory syncytial virus-associated lower respiratory tract disease.

    References

    1. Prescribing Information for AREXVY.

    2. Data on file, GSK.

    Questions About AREXVY?

    Call: 1-877-AREXVY1 (1-877-273-9891) Available Monday - Friday 8:30 am - 5:30 pm ET