A Demonstrated Safety Profile1

For patients aged 60 years and older

Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination in
individuals aged 60 years and older (solicited safety set with 4-day diary card)

 
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
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.

  • a

    Placebo was a saline solution.

  • b

    Any 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).

  • c

    Any grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).

  • d

    Temperature taken by any route (oral, axillary, or tympanic).

In the solicited safety set, the local administration site adverse reactions reported with AREXVY had a median duration of 2 days, and the systemic adverse reactions reported with AREXVY had a median duration ranging between 1 and 2 days.1
Similar rates of SAEs (4.2% vs 4.0%) and pIMDs (0.3% vs 0.3%) were reported between AREXVY (n=12,467) and placebo (n=12,499), respectively.1
Deaths were reported in 0.8% and 0.9% of participants who received AREXVY (n=12,470) and placebo (n=12,503), respectively.

For patients aged 50-59 years

Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination from Study 4 (exposed set)
 
AREXVY 50-59 YOA %
Placeboa 50-59 YOA %
Local Adverse Reactions
N=756
N=379
Pain, Anyb 75.8 12.1
Pain, Grade 3b
 3.4 0.3
Erythema, >20 mm
 13.2 0.5
Erythema, >100 mm
 0.5 0
Swelling, >20 mm 10.4 0.8
Swelling, >100 mm 0.1 0
Systemic Adverse Reactions
N=756
N=380
Fatigue, Anyc 39.8 18.2
Fatigue, Grade 3c 2.8 0.8
Myalgia, Anyc 35.6 9.7
Myalgia, Grade 3c 2.5 0.5
Headache, Anyc 31.7 16.8
Headache, Grade 3c  2.6 1.1
Arthralgia, Anyc 23.4 7.9
Arthralgia, Grade 3c 1.7 0.8
Fever, ≥38.0 °C/100.4 °Fd 3.2 1.1
Fever, >39.0 °C/102.2 °Fd 0.1 0.5
 
AREXVY
50-59 YOA %
Placeboa
50-59 YOA %
Local Adverse Reactions
N=756
N=379
Pain, Anyb 75.8 12.1
Pain, Grade 3b
 3.4 0.3
Erythema, >20 mm
 13.2 0.5
Erythema, >100 mm
 0.5 0
Swelling, >20 mm 10.4 0.8
Swelling, >100 mm 0.1 0
Systemic Adverse Reactions
N=756
N=380
Fatigue, Anyc 39.8 18.2
Fatigue, Grade 3c 2.8 0.8
Myalgia, Anyc 35.6 9.7
Myalgia, Grade 3c 2.5 0.5
Headache, Anyc 31.7 16.8
Headache, Grade 3c  2.6 1.1
Arthralgia, Anyc 23.4 7.9
Arthralgia, Grade 3c 1.7 0.8
Fever, ≥38.0 °C/100.4 °Fd 3.2 1.1
Fever, >39.0 °C/102.2 °Fd 0.1 0.5

N=exposed set included all participants with at least 1 documented dose and with completed diary card.

  • a

    Placebo was a saline solution.

  • b

    Any 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).

  • c

    Any grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).

  • d

    Temperature taken by any route (oral or axillary).

The median duration of solicited local and systemic adverse reactions after AREXVY vaccination was 2-3 days and 1-2 days, respectively.1
The rates of solicited local and systemic adverse reactions were similar in participants 50-59 years of age with or without medical conditions associated with an increased risk of RSV-LRTD.1
Among participants 50-59 years of age, serious adverse events (2.3% vs 2.1%), deaths (0.5% vs 0.3%), and potential immune-mediated diseases (0.5% vs 0.3%) were reported after receiving AREXVY (N=769) or placebo (N=383), respectively.1

Indication & Important Safety Info

Indication

Important Safety Information

Indication

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:

  • individuals 60 years of age and older;
  • individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.

Important Safety Information

  • AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY
  • The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY
  • Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY
  • Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting
  • Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY
  • In adults 60 years of age and older, the most commonly reported adverse reactions (≥10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%)
  • In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%)
  • There are no data on the use of AREXVY in pregnant or breastfeeding individuals. AREXVY is not approved for use in persons <50 years of age
  • Vaccination with AREXVY may not result in protection of all vaccine recipients

 

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or
1-888-825-5249, or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

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

References

  1. Prescribing Information for AREXVY.

Questions About AREXVY?

Call: 1-877-AREXVY1 (1-877-273-9891) Available Monday - Friday 8:30 am - 5:30 pm ET