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SAFETY

Generally well tolerated with an acceptable safety profile1

These adverse (solicited) reactions were usually mild to moderate in intensity and resolved within a few days after vaccination.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)

  AREXVY % Placeboa %
Local Adverse Reactions N=879 N=874
Pain, Anyb 60.9 9.3
Pain, Grade 3b 1 0
Erythema, >20 mm 7.5 0.8
Erythema, >100 mm 0.2 0
Swelling, >20 mm 5.5 0.6
Swelling, >100 mm 0.2 0
  AREXVY % Placeboa %
Systemic Adverse Reactions N=879 N=878
Fatigue, Anyc 33.6 16.1
Fatigue, Grade 3c 1.7 0.5
Myalgia, Anyc 28.9 8.2
Myalgia, Grade 3c 1.4 0.3
Headache, Anyc 27.2 12.6
Headache, Grade 3c 1.3 0
Arthralgia, Anyc 18.1 6.4
Arthralgia, Grade 3c 1.3 0.6
Fever, ≥38.0 °C/100.4 °Fd 2.0 0.3
Fever, >39.0 °C/102.2 °Fd 0.1 0.1

N=exposed set for solicited safety set included all participants with at least 1 documented dose.
aPlacebo was a saline solution.
bAny grade pain: Defined as any pain neither interfering with nor preventing normal everyday activities (Grade 1), painful when limb is moved and interferes with everyday activities (Grade 2), or significant pain at rest and prevents normal everyday activities (Grade 3).
cAny grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).
dTemperature taken by any route (oral, axillary, or tympanic).

  • The safety of AREXVY was evaluated in a placebo-controlled phase 3 clinical study, Study 1 (NCT04886596), conducted in Europe, North America, Asia, and the Southern Hemisphere involving 24,966 participants aged 60 years and older who received at least 1 dose of AREXVY (n=12,467) or placebo (n=12,499).

    In Study 1, solicited adverse events were collected from a subset of study participants (solicited safety set) using standardised paper diary cards during the 4 days (ie, day of vaccination and subsequent 3 days) following a dose of AREXVY (n=879) or placebo (n=874). The remaining study participants did not prospectively record solicited adverse events on a diary card but reported them as unsolicited adverse events.

    In all study participants, unsolicited adverse events were monitored using paper diary cards during the 30-day period following vaccination (day of vaccination and the next 29 days). Participants were monitored for all serious adverse events (SAEs) that occurred during the 6-month period following administration of AREXVY.

    Deaths are collected from vaccination through the first analysis of the ongoing Study 1. Participants were monitored for all potential immune-mediated diseases (pIMDs) that occurred during the 6-month period following administration of AREXVY or placebo.

Additional Safety Data

In the solicited safety set, the local administration site adverse reactions reported with AREXVY had a median duration of 2 days.1

In the solicited safety set, the systemic adverse reactions reported with AREXVY had a median duration ranging between 1 and 2 days.1

Similar rates of SAEs during the 6-month period following administration of AREXVY (n=12,467) and placebo (n=12,499): 522 AREXVY, 506 placebo (4.2% vs 4.0%); deaths: 49 AREXVY, 58 placebo (0.4% vs 0.5%); and pIMDs: 40 AREXVY, 34 placebo (0.3% vs 0.3%) were reported, respectively.1

The most commonly reported (≥10%) adverse reactions were injection site pain (60.9%, 535), fatigue (33.6%, 295), myalgia (28.9%, 254), headache (27.2%, 239), and arthralgia (18.1%, 159).1

Lungs

EFFICACY

Review efficacy data against RSV-LRTD* for your patients aged 60 years and older.1

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two vials and one syringe

ADMINISTRATION

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

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lungs with particles on the right side

VACCINE DESIGN

AREXVY includes both an antigen component and an adjuvant system.1

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Abbreviations

LRTD=lower respiratory tract disease;
pIMD=potential immune-mediated disease;
RSV=respiratory syncytial virus;
SAE=serious adverse event.

References

  1. Arexvy SPC, available from https://www.medicines.ie/medicines/arexvy-powder-and-suspension-for-suspension-for-injection-35441/spc. Accessed April 2024
  2. 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

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.

▼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.

©2023 GSK group of companies. All rights reserved

PM-IE-ABX-WCNT-230002 | April 2024

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