Study 1 in participants 60 years and older

Secondary Endpoints:

Efficacy by RSV Type, Severity, and Age

Severe RSV-LRTD

94.1

%

Efficacy against severe RSV-LRTD in Season 11

 

(95% CI, 62.4, 99.9)

 

AREXVY (1 case out of 12,466),

placebo (17 cases out of 12,494)

 

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

67.4

%

Seasons 1-3 vaccine efficacy against severe RSV-LRTD overall for adults aged ≥60 years2

 

(95% CI, 42.4, 82.7)

 

AREXVY (15 cases out of 12,468),

placebo (75 cases out of 12,498)

 

Median follow-up was 30.6 months.2

RSV-LRTD by Subtypes

84.6

%

Efficacy against RSV A-LRTD in Season 11,3

 

(95% CI, 32.1, 98.3)

 

AREXVY (2 cases out of 12,466),

placebo (13 cases out of 12,494)

 

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

80.9

%

Efficacy against RSV B-LRTD in Season 11,3

 

(95% CI, 49.4, 94.3)

 

AREXVY (5 cases out of 12,466),

placebo (26 cases out of 12,494)

 

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

69.8

%

Seasons 1-3 efficacy against RSV A-LRTD for adults aged ≥60 years1,2

 

(97.5% CI, 42.2-85.7)

 

AREXVY (14 cases out of 12,468),

placebo (80 cases out of 12,498)

 

Median follow-up was 30.6 months.

58.6

%

Seasons 1-3 efficacy against RSV B-LRTD for adults aged ≥60 years1,2

 

(97.5% CI, 35.9-74.1)

 

AREXVY (34 cases out of 12,468),

placebo (135 cases out of 12,498)

 

Median follow-up was 30.6 months.

Subgroup Analysis for Participant’s Age

81.0

%

Efficacy against RSV-LRTD in Season 1 in participants aged 60-69 years1

 

(95% CI, 43.6, 95.3)

 

AREXVY (4 cases out of 6963),

placebo (21 cases out of 6979)

 

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

93.8

%

Efficacy against RSV-LRTD in Season 1 in participants aged 70-79 years1

 

(95% CI, 60.2, 99.9)

 

AREXVY (1 case out of 4487),

placebo (16 cases out of 4487)

 

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

60.3

%

Seasons 1-3 efficacy against RSV-LRTD for participants aged 60-69 years1,2

 

(95% CI, 39.5, 74.8)

 

AREXVY (28 cases out of 6962),

placebo (117 cases out of 6981)

 

Median follow-up was 30.6 months.

70.6

%

Seasons 1-3 efficacy against RSV-LRTD in participants aged 70-79 years1,2

 

(95% CI, 48.4, 84.3)

 

AREXVY (15 cases out of 4489),

placebo (85 cases out of 4489)

 

Median follow-up was 30.6 months.

Vaccine Efficacy Over 2 RSV Seasons, With Median Follow-Up of 17.8 Months1,4

 

  • 78.8% (95% CI, 52.6, 92.0; 7/12,469 in AREXVY vs 48/12,498 in placebo) against severe RSV-LRTD
  • 80.5% (95% CI, 54.0, 93.2; 6/12,469 in AREXVY vs 48/12,498 in placebo) in RSV A-LRTD, 59.7% (95% CI, 35.8, 75.5; 24/12,469 in AREXVY vs 90/12,498 in placebo) in RSV B-LRTD
  • 65.4% (95% CI, 40.4, 80.9; 17/6963 in AREXVY vs 74/6981 in placebo) in participants aged 60-69, 74.9% (95% CI, 48.4, 89.2; 9/4489 in AREXVY vs 55/4489 in placebo) in participants aged 70-79

 

Vaccine Efficacy (VE) for ≥80 years cannot be reliably estimated due to the low number of cases accrued in this age group.1

    Demonstrated Safety Profile

    See the AREXVY safety data

    SAFETY INFORMATION

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

    References

    1. Prescribing Information for AREXVY.

    2. Ison MG, Papi A, Athan E, et al; AReSVi-006 study group. Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three respiratory syncytial virus seasons (AReSVi-006): a multicentre, randomised, observer- blinded, placebo-controlled, phase 3 trial. Lancet Respir Med. Published online April 11, 2025. doi:10.1016/S2213-2600(25)00048-7

    3. Papi A, Ison MG, Langley JM, et al. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med. 2023;388(7):595-608. doi:10.1056/NEJMoa2209604 

    4. 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