Expanded Patient Population

The First RSV Vaccine Approved for Patients 50–59 Years of Age Who Are at Increased Risk* for RSV-LRTD1

Study 4

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Adults aged

50-59

YEARS AT INCREASED RISK* FOR LRTD CAUSED BY RSV

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.

 

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

 

Study 4 Design – Immunobridging

 

In Study 4, individuals 50 through 59 years of age with chronic medical conditions (chronic pulmonary disease, chronic cardiovascular disease, diabetes, or chronic kidney or liver disease) were randomized to receive AREXVY (n=386) or saline placebo (n=191). A comparator group of individuals 60 years and older also received AREXVY (n=381).

 

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 neutralizing antibody responses to RSV-A and RSV-B subtypes in individuals 50 through 59 years of age with chronic medical conditions met the criteria for immunobridging, as the upper limit (UL) of the 2-sided 95% CI for the GMT ratio (GMT for individuals 60 years and older/GMT for individuals 50 through 59 years of age with chronic medical conditions) was ≤1.50 and the UL of the 2-sided 95% CIs for seroresponse rate (SRR) difference (SRR for individuals 60 years and older minus SRR for individuals 50 through 59 years of age with chronic medical conditions) was ≤10% for the RSV-A and RSV-B subtypes.

*Medical conditions defined as1:

Female chronic pulmonary disease patient

Chronic pulmonary disease

Female chronic liver disease patient

Chronic liver disease

Male chronic cardiovascular disease patient

Chronic cardiovascular disease

Male chronic kidney disease patient

Chronic kidney disease

Male diabetes patient

Diabetes

Not actual patients.

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

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.

Questions About AREXVY?

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