Exceptional Efficacy For Your Patients 60+1

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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)

Study 1, a phase 3 study, randomized participants ≥60 years of age to receive 1 dose of AREXVY (n=12,466) or placebo (n=12,494) to evaluate the efficacy of AREXVY in preventing RSV-LRTD in adults 60+.

 

At the time of this analysis, median follow-up was 6.7 months.1

 

See full study design provided below

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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.1

AREXVY Is the Only RSV Vaccine With Efficacy Data Available Through 3 Full Seasons2-4

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SECONDARY ENDPOINTS

Seasons 1-3 Vaccine Efficacy for Adults Aged ≥60 Years, With Median Follow-Up of 30.6 Months2

62.9

%

RSV-LRTD Overall

 

(97.5% CI, 46.7, 74.8)

 

AREXVY (48 cases out of 12,468),

placebo (215 cases out of 12,498)

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64.7

%

Participants With at Least 1 Comorbidity of Interest*

 

(95% CI, 45.1, 78.1)

 

AREXVY (25 cases out of 5014),

placebo (116 cases out of 4951)

Over 2 RSV seasons in Study 1 (median follow-up of 17.8 months), vaccine efficacy against RSV-LRTD was 67.2% (97.5% CI, 48.2, 80.0; 30/12,469 in AREXVY vs 139/12,498 in placebo) in participants aged 60 years and older, and 66.7% (95% CI, 41.8, 82.0; 16/4983 in AREXVY vs 72/4919 in placebo) in participants with at least 1 comorbidity of interest.1*

 

Study 1 also evaluated the efficacy of a single dose of AREXVY in preventing RSV-LRTD in adults aged ≥60 years over 3 seasons (median 30.6 months). Pre-Season 2, participants who received AREXVY were re-randomized to receive placebo (n=4991) or a second dose of AREXVY (n=4966). Participants who received placebo before Season 1 received a second dose of placebo before Season 2 (n=10,031). Participants who received a second dose of AREXVY did not contribute to these efficacy analyses after receipt of Dose 2.2,5

*Comorbidities of interest1

Chronic respiratory or pulmonary disease image

COPD, asthma, or any chronic respiratory/pulmonary disease

Chronic heart failure image

Chronic heart failure

Patient pancreas image

Diabetes mellitus type 1 or type 2

Advanced liver disease patient

Advanced liver disease

Advanced renal disease patient

Advanced renal disease

Not actual patients.

*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.1

 

Respiratory syncytial virus–associated lower respiratory tract disease (RSV-LRTD) was defined based on the following criteria: the participant must have experienced at least 2 lower respiratory symptoms/signs, including at least 1 lower respiratory sign for at least 24 hours, or experienced at least 3 lower respiratory symptoms for at least 24 hours.1

Additional Secondary Endpoints

Dive deeper into the data

LEARN MORE

AREXVY is the first RSV vaccine approved for patients aged 50-59 years at increased risk for RSV-LRTD1

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 older1

STUDY 4-IMMUNOBRIDGING

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.

LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus.

References

  1. Prescribing Information for AREXVY.

  2. Data on file, GSK.

  3. Walsh EE, Pérez Marc G, Falsey AR, et al. RENOIR trial — RSVpreF vaccine efficacy over two seasons. N Engl J Med. 2024;391(15):1459-1460. doi:10.1056/nejmc2311560

  4. 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. 2024;73(32):696-702. doi:10.15585/mmwr.mm7332e1

  5. Ison MG, Papi A, Athan E, et al. Efficacy and safety of respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over 2 RSV seasons. Clin Infect Dis. 2024;78(6):1732-1744. doi:10.1093/cid/ciae010

Questions About AREXVY?

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