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AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)



AREXVY is indicated for active immunisation of individuals 60 years and older for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV).1

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Important Information about AREXVY


82.6% overall efficacy against RSV-LRTD after 6.7 months follow-up*1,3 and 67.2% after 17.8 months follow-up#2 in patients 60 years and over.†1-3

*Primary endpoint, vs. placebo 82.6% (96.95% CI 57.9, 94.1). Primary objective met: lower CI limit >20%.

RSV-LRTD events: AREXVY 7/12,466; placebo 40/12,494.3

#Secondary confirmatory endpoint, single dose vs. placebo§ 67.2% (97.5% CI 48.2, 80.0). Secondary objective met: lower CI limit >20%.

RSV-LRTD events: AREXVY 30/12,469; placebo 139/12,498.2



AREXVY: an acceptable safety profile.¥2,3

¥Median follow-up post-dose 1 of 17.8 months.2, Very common adverse events (≥10%) are headache, myalgia, arthralgia, injection site pain and fatigue. Common adverse events (≥1%) are injection site erythema, injection site swelling, fever, chills and rhinorrhoea (not a complete list; see full PI). 1


Dosing and administration 

AREXVY is administered as a single, reconstituted dose of 0.5 mL by intramuscular injection. The need for revaccination has not been established. 1



  • AREXVY should be refrigerated. DO NOT FREEZE (discard if frozen).1
  • Store in the original package to protect vials from light.
  • Store between 2°C and 8°C before reconstitution.
  • After reconstitution, store between 2°C and 8°C or at room temperature up to 25°C for up to 4 hours prior to use.
  • Discard reconstituted vaccine if not used within 4 hours.


Ongoing, international, randomised, observer-blind, placebo-controlled, phase III trial to evaluate the efficacy of one dose of AREXVY (n=12,466) versus placebo (n=12,494) to prevent RSV-LRTD in adults ≥60 years of age during one RSV season (median follow-up 6.7 months, maximum follow up 10.1 months). RSV-LRTD was confirmed by RT-PCR and defined as presence for ≥24 hours of ≥2 lower respiratory symptoms or signs (including at least one sign) or ≥3 lower respiratory symptoms.3 Efficacy and safety were evaluated over two RSV seasons (median follow-up 17.8 months) of one dose of AREXVY vs. placebo and of a first dose followed by revaccination one year later vs. placebo.2
The criterion for meeting the primary endpoint and confirmatory secondary endpoints was a lower limit of the two-sided CI for vaccine efficacy >20%.2,3
§The co-secondary confirmatory endpoint, overall efficacy of annual revaccination vs. placebo against RSV-LRTD after 17.8 months, was met (67.1%; 97.5% CI 48.1, 80.0).2

Reference Materials



  1. AREXVY Product Information.
  2. Ison MG et al. Clin Infect Dis 2024;doi.org/10.1093/cid/ciae010 (Corrected proof).
  3. Papi A et al. N Engl J Med 2023;388(7):595–608.


Please review Product Information before prescribing. Product Information can be accessed at www.gsk.com.au/arexvy

â–¼This medicinal product is subject to additional monitoring in Australia. This will allow quick
identification of new safety information. Healthcare professionals are asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.

PBS Information: AREXVY is not listed on the PBS or the National Immunisation Program (NIP).

For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109.
Trade marks are owned by or licensed to the GSK group of companies. ©2023 GSK group of companies or its licensor.

GlaxoSmithKline Australia Pty Ltd, Melbourne, VIC.
PM-AU-RSA-WCNT-240009 | Date of approval: March 2024