AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)

INDICATION

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

Important Information about AREXVY

Efficacy

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

Safety

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

Storage¹

• 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