Study 1 in participants 60 years and older

Secondary Endpoints:

Efficacy by Severity, RSV Subtype, 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

%

Efficacy against severe RSV-LRTD over Seasons 1-31

 

(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.1

RSV-LRTD by Subtypes

84.6

%

Efficacy against RSV A-LRTD in Season 11,2

 

(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 11,2

 

(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

%

Efficacy against RSV A-LRTD over Seasons 1-31,3

 

(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

%

Efficacy against RSV B-LRTD over Seasons 1-31,3

 

(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

%

Efficacy against RSV-LRTD among participants aged 60-69 years over Seasons 1-31

 

(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

%

Efficacy against RSV-LRTD among participants aged 70-79 years over Seasons 1-31

 

(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.

    

*The vaccine efficacy in the subgroup of participants 80 years of age and older cannot be reliably estimated due to the low number of cases accrued in this age group. Season 1: 2/1016 in AREXVY vs 3/1028 in placebo. Seasons 1-2: 4/1017 in AREXVY vs 10/1028 in placebo. Seasons 1-3: 5/1017 in AREXVY vs 13/1028 in placebo.1

 

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

    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 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.

    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. 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 

    3. 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

    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