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The Burden of RSV Infection Is High in Older Adults* and Adults With Certain Underlying Conditions1

Not actual patients.

Risk of Hospitalisation From RSV Increases With Age, Especially for Those With Certain Comorbidities2,3

INDICATION

Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:

  • adults 60 years of age and older4;
  • adults 50 through 59 years of age who are at increased risk for RSV disease.4

The use of this vaccine should be in accordance with official recommendations.4
The need for revaccination with a subsequent dose has not been established.
*Older adults are considered aged 60 years and older.

AREXVY Helps to Prevent† RSV-LRTD5-8

A phase 3, randomised, placebo-controlled, observer-blind study in adults aged ≥60 years evaluated the efficacy of a single dose of AREXVY in preventing RSV-LRTD during the first season (primary endpoint), with follow-up planned for up to 36 months. Participants in the primary population for efficacy analysis received 1 dose of AREXVY (n=12,466) or placebo (n=12,494). LRTD was defined as ≥2 lower respiratory symptoms/signs, including ≥1 lower respiratory sign for at least 24 hours, or ≥3 lower respiratory symptoms for at least 24 hours.4,5

SEASON 1

PRIMARY ENDPOINT
OVERALL VACCINE EFFICACY AGAINST RSV-LRTD4,5

82.6 percentage

(96.95% CI, 57.9, 94.1)

NA

AREXVY (7 CASES OUT OF 12,466),
PLACEBO (40 CASES OUT OF 12,494)

At the time of this analysis,
median follow-up was 6.7 months.4,5

SEASON 1-2

SECONDARY CONFIRMATORY ENDPOINT
OVERALL VACCINE EFFICACY AGAINST RSV-LRTD6‡

67.2 percentage

(97.5% CI, 48.2, 80.0)

NA

AREXVY (30 CASES OUT OF 12,469),
PLACEBO (139 CASES OUT OF 12,498)

Median follow-up 17.8 months6

SEASON 1-3

SECONDARY CONFIRMATORY ENDPOINT
OVERALL VACCINE EFFICACY AGAINST RSV-LRTD7,8‡

62.9 percentage

(97.5% CI, 46.7, 74.8)

NA

AREXVY (48 CASES OUT OF 12,468),
PLACEBO (215 CASES OUT OF 12,498)

Median follow-up 30.6 months7

Safety and Tolerability

The most commonly reported adverse reactions up to 4 days after the first dose were injection site pain (61%; n=535/879), fatigue (34%; n=295/879), myalgia (29%; n=254/879), headache (28%; n=239/879), and arthralgia (18%; n=159/879). These adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination.4,5

The frequency of serious events and potential immune-mediated diseases remained low and balanced across groups through the study. No cases of Guillain-Barré syndrome or acute disseminated encephalomyelitis were reported up to study end.7

Guillain-Barré syndrome has been reported very rarely following vaccination in 2 other studies. Healthcare professionals should be attentive to signs and symptoms of Guillain-Barré syndrome in AREXVY recipients to ensure correct diagnosis, initiate adequate supportive care and treatment, and rule out other causes.4

For more information about adverse events, contraindications, and special warnings and precautions for use, see the Summary of Product Characteristics.4

†Vaccination may not protect all recipients.4
‡With season as covariate.

HELP TO PREVENT RSV-LRTD IN AT-RISK PATIENTS AGED 60+4,5

FACHKURZINFORMATION

Arexvy Pulver und Suspension zur Herstellung einer Injektionssuspension Respiratorischer Synzytial-Virus (RSV)-Impfstoff (rekombinant, adjuvantiert); Qualitative und Quantitative Zusammensetzung: Nach der Rekonstitution enthält eine Dosis (0,5 ml): RSVPreF31-Antigen2,3: 120 Mikrogramm; 1 rekombinantes, in der Präfusionskonformation stabilisiertes, Respiratorisches Synzytial-Virus-Glykoprotein F = RSVPreF3; 2 RSVPreF3 hergestellt in immortalisierten Ovarialzellen des chinesischen Hamsters (CHO-Zellen) mittels rekombinanter DNA-Technologie; 3 adjuvantiert mit AS01E; dieses enthält: Pflanzenextrakt aus Quillaja saponaria Molina, Fraktion 21 (QS-21): 25 Mikrogramm, 3-O-Desacyl-4’-monophosphoryl-Lipid A (MPL) aus Salmonella minnesota: 25 Mikrogramm; Sonstige Bestandteile: Pulver (RSVPreF3-Antigen): Trehalose-Dihydrat, Polysorbat 80 (E 433), Kaliumdihydrogenphosphat (E 340), Kaliummonohydrogenphosphat (E 340); Suspension (AS01E Adjuvanssystem): Colfosceriloleat (E 322), Cholesterol, Natriumchlorid, Natriummonohydrogenphosphat (E 339), Kaliumdihydrogenphosphat (E 340), Wasser für Injektionszwecke, Adjuvans siehe auch Fachinformation Abschnitt 2.
Pharmakotherapeutische Gruppe: Impfstoffe, Andere virale Impfstoffe, ATC-Code: J07BX05. Anwendungsgebiete: Arexvy ist indiziert für die aktive Immunisierung zur Prävention von durch das Respiratorische Synzytial-Virus verursachten Erkrankungen der unteren Atemwege (lower respiratory tract disease, LRTD) von: - Erwachsenen im Alter von 60 Jahren und älter. - Erwachsenen im Alter von 50 bis 59 Jahren mit erhöhtem Risiko für eine RSV-Erkrankung. Die Anwendung von Arexvy sollte gemäß offiziellen Empfehlungen erfolgen. Gegenanzeigen: Überempfindlichkeit gegen die Wirkstoffe oder einen der in der Fachinformation Abschnitt 6.1 genannten sonstigen Bestandteile. Inhaber der Zulassung: GlaxoSmithKline Biologicals SA, Rue de l’Institut 89, 1330 Rixensart, Belgien. Rezeptpflicht/Apothekenpflicht: Rezept- und apothekenpflichtig, wiederholte Abgabe verboten. Zulassungsnummer: EU/1/23/1740/001, EU/1/23/1740/002. ▼Dieses Arzneimittel unterliegt einer zusätzlichen Überwachung. Dies ermöglicht eine Schnelle Identifizierung neuer Erkenntnisse über die Sicherheit. Angehörige von Gesundheitsberufen sind aufgefordert, jeden Verdachtsfall einer Nebenwirkung zu melden. Hinweise zur Meldung von Nebenwirkungen, siehe Fachinformation Abschnitt 4.8. Weitere Angaben zu Warnhinweisen und Vorsichtsmaßnahmen für die Anwendung, Wechselwirkungen mit anderen Arzneimitteln und sonstigen Wechselwirkungen, Fertilität, Schwangerschaft und Stillzeit und Nebenwirkungen entnehmen Sie bitte der veröffentlichten Fachinformation.

Ausführliche Informationen zu diesem Arzneimittel sind auf den Internetseiten der Europäischen
Arzneimittel-Agentur http://www.ema.europa.eu/ verfügbar.

Stand der Fachkurzinformation: 08/2024

References

  1. 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
  2. Branche AR, Saiman L, Walsh EE, et al. Incidence of respiratory syncytial virus infection among hospitalized adults, 2017-2020. Clin Infect Dis. 2022;74(6):1004-1011. doi:10.1093/cid/ciab595
  3. Colosia AD, Yang J, Hillson E, et al. The epidemiology of medically attended respiratory syncytial virus in older adults in the United States: a systematic review. PLoS One. 2017;12(8):e0182321. doi:10.1371/journal.pone.0182321
  4. Summary of Product Characteristics for AREXVY.
  5. 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(7):595-608. doi:10.1056/NEJMoa2209604
  6. Ison MG, Papi A, Athan E, et al. Efficacy and safety of respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over 2 RSV seasons. Clin Infect Dis. 2024;78(6):1732-1744. doi:10.1093/cid/ciae010
  7. Ison MG et al. The Efficacy of a Single Dose of the Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults ≥60 Years of Age Over 3 RSV Seasons. Abstract at CHEST annual meeting, 6-9 Oct, Boston, USA. CHEST 2024 Abstract link (Checked on 31 January 2025)
  8. Ison MG et al. The Efficacy of a Single Dose of the Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults ≥60 Years of Age Over 3 RSV Seasons. Poster presented at CHEST annual meeting, 6-9 Oct, Boston, USA. CHEST 2024 Poster link (Checked on 31 January 2025)

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 +44 (0) 800 221 441 or UKSafety@gsk.com.

PM-GBL-RSA-WCNT-240007 | April 2025