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AREXVY efficacy and safety overview

Overall efficacy in helping protect adults aged 60 years and older against RSV-LRTD from both A+B subtypes

82.6%

PRIMARY ENDPOINT1,2

(96.95% CI, 57.9, 94.1)

AREXVY 7 cases of RSV out of 12,466.
Placebo 40 cases of RSV out of 12,494.

Efficacy in helping protect against RSV-LRTD for patients with at least 1 comorbidity of interest*

94.6%

SECONDARY ENDPOINT1,2

(95% CI, 65.9, 99.9)

AREXVY 1 case of RSV out of 4937.
Placebo 18 cases of RSV out of 4861

AREXVY safety data: generally well tolerated 
Most reactions were mild or moderate. 
The most commonly solicited reported  (≥10%) adverse reactions were injection site pain (61%, n=535), fatigue (61%, n=295), myalgia (29%, n=254), headache (28%, n=239), and arthralgia (18%, n=159).1,2  The overall size of the solicited safety cohort was n=879.

Grade 3 injection site pain was reported by 1% (n=9) of participants.3

Unsolicited adverse events were reported by 33% in the exposed population of 12,467.2

*Comorbidities of interest1: chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced liver or renal disease.

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What is RSV?

RESPIRATORY SYNCYTIAL VIRUS (RSV) IS A COMMON AND CONTAGIOUS RNA VIRUS.4-7

  • There are two subtypes of RSV, RSV-A and RSV-B.8
  • Many people think RSV is just a disease of concern for infants.9
  • Each year in industrialised countries, in patients 60 years of age and older, RSV causes approximately:9
5.2 million cases of acute respiratory infection

5.2 M cases of acute respiratory infection (ARI)

470,000 hospitalisations

470,000 hospitalisations

33,000 in hospital deaths

33,000 in-hospital deaths

Who is at risk?

THOSE AT INCREASED RISK FOR SEVERE ILLNESS FROM RSV INCLUDE8:

 

Older adults, especially those 60 years of age and older

Older adults, especially those 60 years of age and older.4,5

Adults with chronic lung of heart disease

Adults with chronic lung or heart disease.10

Adults with weakened immune systems

Adults with weakened inmune systems.10

Older Adults risk

HOSPITALISATION RATES FROM RSV INFECTION INCREASE WITH AGE*

NA

*Includes data from high and low risk groups. Risk group defined according to the chronic conditions indicative of risk for severe infleunza as per UK recommendations for influenza vaccination. These include chronic obstructive respiratory disease; cardiovascular, central nervous system, renal and liver disorders; diabetes; immunosuppressive conditions or stroke

Safety profile

AREXVY SAFETY DATA: GENERALLY WELL TOLERATED1,2

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 61
 9.3
Pain, Grade 3b 1.3
 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

Although solicited injection site pain was reported by 60.9% of participants, Grade 3 injection site pain was reported by 1% (n=9) of participant.3

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).

  AREXVY% Placeboa%
Systemic Adverse Reactions n=879 n=878
Fatigue, Anya 34
 16.1
Fatigue, Grade 3a 1.7 0.5
Myalgia, Anya 29
 8.2
Myalgia, Grade 3a 1.4 0.3
Headache, Anya 28
 12.6
Headache, Grade 3a 1.3 0
Arthralgia, Anya 18
 6.4
Arthralgia, Grade 3a 1.3 0.6
Fever, >38.0ºC/100.4ºFb 2.0 0.3
Fever, >39.0ºC/102.2ºFb 0.1 0.1

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

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

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

References

  1. AREXVY Summary of Product Characteristics (SmPC)
  2. Papi A, Ison MG, Langley JM, et al., for the AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med. 2023;388:595-608. DOI: 10.1056/NEJMoa2209604
  3. GSK. Data on file. Solicited Local Adverse Reactions and Systemic Adverse Reactions
  4. Nguyen-Van-Tam JS, O’Leary M, Martin ET, et al. Burden of respiratory syncytial virus infection in older and high-risk adults: a systematic review and meta-analysis of the evidence from developed countries. Eur Respir Rev. 2022;31(166):220105. doi:10.1183/16000617.0105-2022.
  5. Stephens LM, Varga SM. Considerations for a respiratory syncytial virus vaccine targeting an elderly population. Vaccines (Basel). 2021;9(6):624. doi:10.3390/vaccines9060624.
  6. Mesa-Frias M, Rossi C, Edmond B, et al. Incidence and economic burden of respiratory syncytial virus among adults in the United States: a retrospective analysis using 2 insurance claims databases. J Manag Care Spec Pharm. 2022;28(7):753-765. doi:10.18553/jmcp.2022.21459
  7. Kodama F, Nace DA, Jump RL. Respiratory syncytial virus and other noninfluenza respiratory viruses in older adults. Infect Dis Clin North Am. 2017;31(4):767-790. doi:10.1016/j.idc.2017.07.006.
  8. Giffiths C, Drews SJ, Marchant DJ. Respiratory syncytial virus: infection, detection, and new options for prevention and treatment. Clin Microbiol Rev. 2017;30(1):277-319. doi:10.1128/CMR.00010-16.
  9. Savic M, Penders Y, Shi T, Branche A, Pirçon J-Y. Respiratory syncytial virus disease burden in adults aged 60 years and older in high-income countries: a systematic literature review and meta-analysis [published online ahead of print November 11, 2022].Influenza Other Respir Viruses. 2023;17(1):e13031. doi:10.1111/irv.13031.
  10. RSV in older adults and adults with chronic medical conditions. Centers for Disease Control and Prevention. Accessed March 2024. www.cdc.gov/rsv/high-risk/older-adults.html
  11. Fleming et al. BMC Infectious Diseases (2015)15:443. DOI 10.1186/s12879-015-1218-z.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App Store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441 or UKSafety@gsk.com

April 2024 | PM-GB-RSA-WCNT-230014 (V2.0)