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#354 – Preventing RSV in the elderly

What is the effectiveness and safety of Respiratory Syncytial Virus (RSV) vaccination in older adults?

For every ~380 medically-stable patients aged ≥60, RSV vaccine prevents 1 RSV-associated lower respiratory tract disease (LRTD) per season over placebo. Study conducted during COVID-19 pandemic, potentially lowering baseline RSV incidence. Fatigue occurs in 34% versus 16% (placebo). General guidance suggests administration based on shared decision-making, particularly those at higher-risk (example long-term care, COPD), but higher-risk largely not studied.

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  • Statistically significant unless noted.
  • Randomized controlled trial (RCT):1 24,966 adults >60 years given single-dose adjuvanted RSV prefusion F protein vaccine (RSVPreF3 OA vaccine, Arexvy®) or placebo. Planned 3-years; First RSV-season (6.7 months) results:
    • RSV-LRTD: 0.06% versus 0.3% (placebo); Number needed to vaccinate (NNV)=379.
    • “Severe” (>2 clinical signs or investigator-assessed) RSV-LRTD: 0.008% versus 0.1% (placebo), NNV=781.
    • Injection site pain (61% versus 9%); fatigue (34% versus 16%): no statistics.
  • RCT:2 34,284 adults >60 years given single-dose unadjuvanted RSVpreF vaccine (Abrysvo®) or placebo. First RSV-season (7 months) results:
    • RSV-LRTD (≥2 signs/symptoms): 0.07% versus 0.2% (placebo), NNV=742.
    • RSV-LRTD (>3 signs/symptoms): 0.01% versus 0.08% (placebo), NNV=1360.
    • Local reactions: 12% versus 7%, no statistics.
  • Systematic review: Published/unpublished two-season results of above RCTs (no statistics).3
    • RSV-LRTD relative efficacy:
      • Arexvy®: 83% (season 1) versus 56% (season 2).
      • Abrysvo®: 89% (season 1) versus 79% (season 2).
      • Actual events not reported.
    • Hospitalizations/deaths:
      • Arexvy®: 0.008% versus 0.04%.
      • Abrysvo®: 0.006% versus 0.02%.
      • No RSV-related deaths.
    • Safety:
      • Atrial fibrillation: 0.06%-0.08% versus 0.02%-0.03% (placebo).
      • 3 inflammatory neurologic events (example Guillain-Barré) with each Arexvy® (non-placebo-controlled trials) and Abrysvo® (placebo=0).
  • Limitations: Industry-funded; studied during pandemic; immunocompromised, unstable comorbidities, and long-term care generally not included.

  • Arexvy® approved in Canada; ~$250/injection.4
    • Abrysvo® not yet approved in Canada.
  • RSV risk >50 years: 1.6-4.9%/year,5-7 declined during pandemic.5,8
    • RSV hospitalization risk >65: 0.02%-0.26%/year.7,9-12
    • Mortality 7-15% in RSV-hospitalized ≥60,7,12 increased with advancing age, long-term care, and comorbidities like chronic kidney disease/COPD.9,12
  • Risk of contracting influenza either 2-10x higher8,10-13 or similar to RSV.14
  • US guidance recommends shared decision-making (aid available)15 for vaccinating ≥60.3

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  • Danielle Perry RN MSc
  • G. Michael Allan MD CCFP

1. Papi A, Ison MG, Langley JM, et al. N Engl J Med. 2023; 16;388(7):595-608.

2. Walsh EE, Perez Marc G, Zareba AM, et al. N Engl J Med. 2023; 20;388(16):1465-77.

3. Melgar M, Britton A, Roper LE, et al. MMWR Morb Mortal Wkly Rep. 2023; 72(29):793-801.

4. Arexvy® cost: Personal communication with Will Chan, Alberta community pharmacist on November 24, 2023.

5. Juhn YJ, Wi CI, Takahashi PY, et al. JAMA Netw Open. 2023;6(1):e2250634.

6. Nguyen-Van-Tam JS, O'Leary M, et al. Eur Respir Rev. 2022;31(166):220105.

7. Savic M, Penders Y, Shi T, et al. Influenza Other Respir Viruses. 2023;17(1):e13031.

8. Nasrullah A, Gangu K, Garg I, et al. Vaccines (Basel). 2023;11(2):412.

9. Branche AR, Saiman L, Walsh EE, et al. Clin Infect Dis. 2022;74(6):1004-11.

10. Matias G, Taylor R, Haguinet F, et al. BMC Public Health. 2017;17(1):271.

11. Zhou H, Thompson WW, Viboud CG, et al. Clin Infect Dis. 2012;54(10):1427-36.

12. Hamilton MA, Liu Y, Calzavara A, et al. Influenza Other Respir Viruses. 2022;16(6):1072-81.

13. Surie D, Yuengling KA, DeCuir J, et al. MMWR Morb Mortal Wkly Rep 2023;72:1083–88.

14. Maggi S, Veronese N, Burgio M, et al. Vaccines (Basel). 2022;10(12):2092.

15. Centre for Disease Control and Prevention (USA). Shared Clinical Decision-Making (SCDM) RSV Vaccination for Adults 60 Years and Older. On-line. Available at: Accessed on: Nov 24, 2023

Authors do not have any conflicts of interest to declare