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These adverse (solicited) reactions were usually mild to moderate in intensity and resolved within a few days after vaccination.1,2

  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.2

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

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.2

In study participants 60 years of age and older, the most commonly reported adverse reactions were injection site pain
(61%), fatigue (34%), myalgia (29%), headache (28%), and arthralgia (18%).1

Lungs

EFFICACY

Review efficacy data against RSV-LRTD for your patients aged 60 years and older.3

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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

MECHANISM OF ACTION

AREXVY includes both an antigen component and an adjuvant system.3

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Abbreviations

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

Arexvy Safety Information1

Contraindications:
Hypersensitivity to the active substances or to any of the excipients listed in sections “Powder (RSVPreF3 antigen and Suspension (AS01E Adjuvant System)”

Special Warnings and Precautions: 
Prior to immunisation appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. Vaccination should be postponed in individuals suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination. As with any vaccine, a protective immune response may not be elicited in all vaccinees. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with the vaccination process itself. It is important that precautions are in place to avoid injury from fainting. Precautions for use Do not administer the vaccine intravascularly or intradermally. No data are available on subcutaneous administration of Arexvy. As with other intramuscular injections, Arexvy should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these individuals. Systemic immunosuppressive medicinal products and immunodeficiency Safety and immunogenicity data on Arexvy are not available for immunocompromised individuals. Patients receiving immunosuppresive treatment or patients with immunodeficiency may have a reduced immune response to Arexvy.

Pregnancy and breast-feeding: 
There are no data from the use of Arexvy in pregnant women. After administration of an investigational unadjuvanted RSVPreF3 vaccine to 3 557 pregnant women in a single clinical study, an increase in preterm births was observed compared to placebo. Currently no conclusion on a causal relationship between administration of unadjuvanted RSVPreF3 and preterm birth can be drawn. Results from animal studies with an investigational unadjuvanted RSVPreF3 vaccine and results with Arexvy do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Arexvy is not recommended during pregnancy. 

There are no data on the excretion of Arexvy in human or animal milk. Arexvy is not recommended in breast-feeding/lactating women. 

Undesirable effects 

Very common: Headache, myalgia, arthralgia, injection site pain, fatigue

Common: Injection site erythema, injection site swelling, fever, chills

References

  1. Prescribing Information for AREXVY.
  2. Papi A, Ison MG, Langley JM, et al. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med. 2023;388(7):595-608. doi:10.1056/NEJMoa2209604

For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via
 Gulf.ProductQualityComplaints@gsk.com

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PM-RCH-RSA-WCNT-240001 | August 2024