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AREXVY is the only RSV vaccine with published efficacy data across 3 full RSV seasons. *‡+4

*Vaccination may not prevent RSV-LRTD in all recipients.1,2

‡Participants in the Northern Hemisphere were followed for 3 consecutive RSV seasons (seasons defined as from 1 October to 30 April); those in the Southern Hemisphere for at least 2 consecutive seasons (seasons defined as from 1 March to 30 September) and evaluated in a phase 3, observer-blind, randomised, placebo-controlled study

Efficacy demonstrated against RSV-LRTD for patients aged 60 years and older in Season 1.1

Content Cards - Efficacy Graphic

*Vaccination does not protect all recipients1
†*comorbidities of interest3: Chronic obstructive pulmonary disease (COPD), asthma, any other chronic respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2 or liver or renal diseases (endocrinometabolic).1
Efficacy against RSV-associated LRTD in adults 60 years and older was evaluated for up to 3 RSV seasons in a Phase III, randomised, placebo-controlled, observer-blind clinical study conducted in 17 countries from Northern and Southern Hemispheres. Overall, 24 960 participants were randomised equally to receive 1 dose of Arexvy (N= 12 466) or placebo (N= 12 494) during the first season.
CI = Confidence Interval; LRTD = Lower Respiratory Tract Disease; RSV = Respiratory Syncytial Virus.

Efficacy was established in patients with at least 1 comorbidity of interest:3

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

Caucasian Woman Patient in denim jacket

Advanced liver or renal disease

Not actual patients.

Administration and storage

  • Arexvy is supplied as 2 vials. The powder and suspension must be reconstituted before administration.1
  • Administer 1 dose (0.5 ml) of Arexvy as an intramuscular injection, preferably in the deltoid muscle.1
  • Arexvy can be administered concomitantly with inactivated seasonal influenza vaccines (standard dose unadjuvanted, high dose unadjuvanted, or standard dose adjuvanted).1
  • Arexvy should be refrigerated. DO NOT FREEZE (discard if frozen).1

VIEW FULL PRESCRIBING INFORMATION

syringe et vials

Safety Profile

Clinically acceptable safety profile

Arexvy is administered as a single 0.5 mL intramuscular dose, preferably in the deltoid muscle. Very common side effects (≥1/10): Headache, myalgia, arthralgia, injection site pain, injection site erythema, fatigue. Common side effects (≥1/100 to <1/10): injection site swelling, fever, chills. Uncommon side effects (≥1/1000 to <1/100): lymphadenopathy, hypersensitivity reactions, nausea, abdominal pain, vomiting, injection site pruritus, pain, malaise. Medical supervision is advised for potential anaphylaxis. Vaccination should be postponed during acute febrile illness. Anxiety-related reactions may occur in association with the vaccination process itself. Caution in individuals with thrombocytopenia or coagulation disorder. Patients with immunodeficiency or on immunosuppressive treatment may have a reduced immune response to Arexvy. No data on the effects on human fertility. Not recommended during pregnancy or in breast-feeding/lactating women.1

Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination in adults aged 60 years and older (solicited safety set with 4-day diary card, N=1757)3, 4

Question about AREXVY?

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How to order AREXVY

Wholesalers in Ireland:

  • United Drug – 01 463 2300
  • Uniphar – 01 468 7501

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

References:

  1. AREXVY Summary of Product Characteristics, GSK.
  2. Ison MG, Papi A, Athan E, et al. 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. The Lancet RespMed. 2025. Published Online April 14, 2025: https://www.medicines.ie/medicines/arexvy-powder-and-suspension-for-suspension-for-injection-35441/spc
  3. Papi A, lson MG, Langley JM, et for the AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med. 2023;388(7):595-608. doi:10.1056/NEJMoa2209604
  4. Arexvy CHMP assessment report, European Medicines Agency (EMA) April 2023
  5. 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 - PubMed

POM. Further information is available from GlaxoSmithKline (Ireland) Ltd

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie.
Adverse events should also be reported to GlaxoSmithKline on 1800 244 255 or via online form https://gsk.public.reportum.com/.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Arexvy is a registered trademark of the GlaxoSmithKline group of companies.

©2026 GSK group of companies. All rights reserved.

PM-IE-RSA-WCNT-260001 | March 2026