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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  • Systematic review: Published/unpublished two-season results of above RCTs (no statistics).3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

Andrew Worster December 11, 2023

Good topic and review

Andre Toit December 11, 2023


Omid YAHYAZADEH December 12, 2023

Good update

Nonyelum Agomo December 12, 2023

Helpful summary

Nasir Ayub December 13, 2023

Nice updated Guideline

Colin Baxter December 13, 2023

Evidence may not convinced some POA

Colin Baxter December 13, 2023

Evidence may not convince some families

Greg Sherman December 14, 2023


Sayema Parveen December 31, 2023

good to know about the above statistics

William Dobson January 8, 2024

useful information

paul duchastel January 24, 2024

Does not seem a useful vaccine

Jennifer MacDonald February 4, 2024

Most of my high risk patients who may derive a benefit can’t afford it
Good review, thanks!

James Livingstone February 11, 2024

need studies focusing on the benefits (?significant risk reduction) in the high risk population before this vaccine has much of a role in current clinical practice

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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