Exceptional Efficacy For Your Patients 60+1

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+ for up to 3 RSV seasons.

 

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

 

See full study design provided below

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 Seasons1-3

SECONDARY ENDPOINTS

Seasons 1-3 Vaccine Efficacy for Adults Aged ≥60 Years, With Median Follow-Up of 30.6 Months Up to the End of the Third Season1

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)

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 evaluated the efficacy of a single dose of AREXVY in preventing RSV-LRTD in adults aged ≥60 years up to the end of the third RSV season (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 (N=12,498) 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. The efficacy analysis up to the end of the third RSV season included participants who received a single dose of AREXVY before Season 1 (N=12,468); duplicate data from one participant was excluded from end of Season 3 analysis.1

*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

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

Effectiveness of AREXVY in individuals 50 through 59 years of age with chronic medical conditions† was assessed by a comparison of RSV neutralizing antibody responses induced by AREXVY in this age group to antibody responses of individuals 60 years of age and older. The comparison met the criteria for immunobridging.1

 

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

 

†Medical conditions defined as: chronic pulmonary disease, chronic cardiovascular disease, diabetes, or chronic kidney or liver disease.1

EFFECTIVENESS FOR 50-59

Additional Secondary Endpoints

Dive deeper into the data

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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.

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

References

  1. Prescribing Information for AREXVY.

  2. 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

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

Questions About AREXVY?

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