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EXCEPTIONAL EFFICACY AGAINST RSV-LRTD FOR YOUR PATIENTS AGED 60 YEARS AND OLDER1

82.6%

PRIMARY ENDPOINT

82.6% OVERALL EFFICACY IN PROTECTING* AGAINST RSV-LRTD

(96.95% CI, 57.9, 94.1%)

94.6%

SECONDARY ENDPOINT

94.6% EFFICACY IN PROTECTING* AGAINST RSV-LRTD FOR PATIENTS WITH AT LEAST 1 COMORBIDITY OF INTEREST1

(95% CI, 65.88, 99.87)

AREXVY (1 case out of 4937), placebo (18 cases out of 4861)

Study 1, an ongoing phase 3 study, randomised participants ≥60 years of age to receive 1 dose of AREXVY (n=12,466) or placebo (n=12,494). Median follow-up for this analysis was 6.7 months.1

  • Vaccination may not protect all recipients1

    The efficacy of AREXVY against RSV-associated LRTD in adults 60 years and older was evaluated in an ongoing, phase 3, randomised, placebo-controlled, observer-blind clinical study conducted in 17 countries from Northern and Southern Hemispheres. Participants are planned to be followed for up to 36 months.

    The primary population for efficacy analysis (referred to as the modified exposed set, which included adults 60 years of age and older receiving 1 dose of AREXVY or placebo who did not report an RSV-confirmed acute respiratory infection (ARI) prior to Day 15 after vaccination) included 24,960 participants randomised equally to receive 1 dose of AREXVY (n=12,466) or placebo (n=12,494). At the time of the primary efficacy analysis, participants had been followed for the development of RSV-associated LRTD for up to 10 months (median of 6.7 months).

    At baseline, 39.3% of participants had at least 1 comorbidity of interest; 19.7% of participants had an underlying cardiorespiratory condition (COPD, asthma, any chronic respiratory/pulmonary disease, or chronic heart failure) and 25.8% of participants had endocrinometabolic conditions (diabetes, advanced liver or renal disease).

    Definition: RSV-LRTD
    Respiratory syncytial virus–associated lower respiratory tract disease (RSV-LRTD) was defined as at least 2 lower respiratory symptoms/signs, including at least 1 lower respiratory sign for at least 24 hours, or at least 3 lower respiratory symptoms for at least 24 hours.1

    Lower respiratory symptoms included: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, crackles/rhonchi, respiratory rate ≥20 respirations/min, low or decreased oxygen saturation (O2 saturation <95% or ≤90% if baseline is <95%), need for oxygen supplementation.1

    Definition: Severe RSV-LRTD
    Severe RSV-associated LRTD was defined as RT-PCR–confirmed RSV-associated LRTD with at least 2 lower respiratory signs, or as an RT-PCR–confirmed RSV-associated LRTD episode assessed as 'severe' by the investigator.1

    Definition: RSV-ARI
    Acute respiratory infection (ARI) was defined by the presence of at least 2 respiratory symptoms/signs for at least 24 hours, or at least 1 respiratory symptom/sign plus 1 systemic symptom/sign (fever or feverishness, fatigue, body aches, headache, decreased appetite) for at least 24 hours.1

woman standing with hands together with lungs illuminated

COPD, asthma, or any chronic respiratory/pulmonary disease

man standing with his arms crossed with heart illuminated

Chronic heart failure

man sitting down with liver illuminated

Diabetes mellitus type 1 or type 2

woman sitting down with cane

Advanced liver or renal disease

Not actual patients.

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SAFETY

Review the safety findings now.2

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SECONDARY ANALYSES

AREXVY showed consistent high efficacy in protecting* against RSV-LRTD observed across secondary endpoints.1

*Vaccination may not protect all recipients.1

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two vials and a syringe

ADMINISTRATION

Review details on dosing and administration of AREXVY to learn about the reconstitution process.

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Abbreviations

COPD=chronic obstructive pulmonary disease; LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus.

Arexvy Safety Information1

Contraindications:
Hypersensitivity to the active substances or to any of the excipients listed in sections “Powder (RSVPreF3 antigen and Suspension (AS01E Adjuvant System)”

Special Warnings and Precautions: 
Prior to immunisation appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. Vaccination should be postponed in individuals suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination. As with any vaccine, a protective immune response may not be elicited in all vaccinees. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with the vaccination process itself. It is important that precautions are in place to avoid injury from fainting. Precautions for use Do not administer the vaccine intravascularly or intradermally. No data are available on subcutaneous administration of Arexvy. As with other intramuscular injections, Arexvy should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these individuals. Systemic immunosuppressive medicinal products and immunodeficiency Safety and immunogenicity data on Arexvy are not available for immunocompromised individuals. Patients receiving immunosuppresive treatment or patients with immunodeficiency may have a reduced immune response to Arexvy.

Pregnancy and breast-feeding: 
There are no data from the use of Arexvy in pregnant women. After administration of an investigational unadjuvanted RSVPreF3 vaccine to 3 557 pregnant women in a single clinical study, an increase in preterm births was observed compared to placebo. Currently no conclusion on a causal relationship between administration of unadjuvanted RSVPreF3 and preterm birth can be drawn. Results from animal studies with an investigational unadjuvanted RSVPreF3 vaccine and results with Arexvy do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Arexvy is not recommended during pregnancy. 

There are no data on the excretion of Arexvy in human or animal milk. Arexvy is not recommended in breast-feeding/lactating women. 

Undesirable effects 

Very common: Headache, myalgia, arthralgia, injection site pain, fatigue

Common: Injection site erythema, injection site swelling, fever, chills

References

  1. Prescribing Information for AREXVY.
  2. Papi A, Ison MG, Langley JM, et al; for the AReSVi-006 Study Group.
    Supplementary appendix to: Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med. 2023;388(7):595-608. doi:10.1056/NEJMoa2209604

For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via
 Gulf.ProductQualityComplaints@gsk.com

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PM-RCH-RSA-WCNT-240001 | August 2024