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

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.

VIEW DEMONSTRATED SAFETY PROFILE

The CDC Recommendation for RSV Vaccination2

The CDC recommends

 

  • Adults 60-74 years of age who are at increased risk of severe RSV disease receive a single dose of RSV vaccine
  • Adults 75 years of age and older 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

 

List of CDC-Identified Risk Factors for Severe RSV Disease3
 
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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 9.6 million adults 60 years and older vaccinated against RSV-LRTD with AREXVY as of March 2025.

 

‡Retail claims July 2023-March 2025; retail making up majority of RSV market.4

 

§Based on data of total retail pharmacy prescriptions in the US from July 2023 through March 2025, showing 9.64 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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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 50 through 59 years of age who are at increased risk for LRTD caused by RSV.

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%)
  • There are no data on the use of AREXVY in pregnant or breastfeeding individuals. AREXVY is not approved for use in persons <50 years of age
  • 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=respiratory syncytial virus; RSV-LRTD=respiratory syncytial virus-associated lower respiratory tract disease.

References

  1. Prescribing Information for AREXVY.

  2. RSV vaccine guidance for older adults. Centers for Disease Control and Prevention. Accessed March 3, 2025.

    https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/older-adults.html

  3. Britton A, Roper LE, Kotton CN, et al. Use of respiratory syncytial virus vaccines in adults aged ≥60 years: updated recommendations of the Advisory Committee on Immunization Practices — United States, 2024. MMWR. Published online August 6, 2024. doi:10.15585/mmwr.mm7332e1

  4. 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