recombinant Herpes zoster vaccine (Shingrix)

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[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17]

Indications

* regardless of previous immunization or prior infection[13]

Contraindications

* safe for patients regardless of history of prior vaccination or infection[13]

Benefit/risk

Dosage

  • two doses IM 2-6 months apart[13]
  • may be given simultaneously with other vaccines

* Shingrix also recommended (1 dose) after Zostvax[6][9]

Keep frozen (< -15 degrees C), reconstitute & use immediately. 19,400 plaque forming units per dose

Pharmacokinetics

  • Shingrix reportedly 84% effective after 5-7 years[12]
    • effective after 4 years[17]

Adverse effects

  • local reactions, most mild to moderate (75%)
  • mild systemic reactions (fatigue) 50%
  • adverse effects with Shingrix not greater than Zostavax
    • 3% of adverse effects with Shingrix serious (hospitalization, life-threatening illness)
    • rate of 4.0 serious events per 100,000 doses (Shingrix)
    • rate of 4.4 serious events per 100,000 doses (Zostavax)
  • most commonly reported adverse events with Shingrix were fever (24%), injection site pain, & chills 4]
  • risk of Guillain-Barre syndrome is low (10 excess cases per 1 million vaccinations in one analysis)[5]

Mechanism of action

Notes

More general terms

References

  1. ↑ Cunningham AL, Lal H, Kovac M et al Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. N Engl J Med 2016; 375:1019-1032. September 15, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27626517 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1603800
    Neuzil KM, Griffin MR Preventing Shingles and Its Complications in Older Persons. N Engl J Med 2016; 375:1079-1080. September 15, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27626522 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMe1610652
  2. ↑ 2.0 2.1 Anderson TC, Masters NB, Guo A et al. Use of recombinant zoster vaccine in immunocompromised adults aged >=19 years: Recommendations of the advisory committee on immunization practices - United States, 2022. MMWR Morb Mortal Wkly Rep 2022 Jan 21; 71:80-84 https://www.cdc.gov/mmwr/volumes/71/wr/mm7103a2.htm
  3. ↑ 3.0 3.1 Le P, Rothberg, MB Cost-effectiveness of the Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. JAMA Intern Med. Published online January 2, 2018. PMID: https://www.ncbi.nlm.nih.gov/pubmed/29297049 https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2666789
    Najafzadeh M. Evolution of Herpes Zoster Vaccines and Their Economic Value. JAMA Intern Med. Published online January 2, 2018 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29297047 https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2666787
  4. ↑ Hesse EM, Shimabukuro TT, Su JR, et al. Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) - United States, October 2017 - June 2018. MMWR Morb Mortal Wkly Rep 2019;68:91-94 https://www.cdc.gov/mmwr/volumes/68/wr/mm6804a4.htm
  5. ↑ 5.0 5.1 Goud R, Lufkin B, Duffy J et al. Risk of Guillain-Barre syndrome following recombinant zoster vaccine in Medicare beneficiaries. JAMA Intern Med 2021 Nov 1; [e-pub] PMID: https://www.ncbi.nlm.nih.gov/pubmed/34724025 https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2785607
  6. ↑ 6.0 6.1 6.2 NEJM JWatch Editors FDA Advisers Recommend Approval of New Shingles Vaccine. Physician's First Watch, Sept 14,2017 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
    GlaxoSmithKline. Oct 23, 2017 Shingrix approved in the US for prevention of shingles in adults aged 50 and over. Pooled clinical trial results showed > 90 percent efficacy across all age groups. https://www.gsk.com/en-gb/media/press-releases/shingrix-approved-in-the-us-for-prevention-of-shingles-in-adults-aged-50-and-over/
    Young K, Sadoughi S, Saitz R CDC Advisers Recommend New Herpes Zoster Vaccine over Zostavax. Physician's First Watch, Oct 23, 2017 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
  7. ↑ Morrison VA et al. Long-term persistence of zoster vaccine efficacy. Clin Infect Dis 2015 Mar 15; 60:900 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25416754 <Internet> http://cid.oxfordjournals.org/content/60/6/900
    Whitley RJ. Waning efficacy of the herpes zoster vaccine. Clin Infect Dis 2015 Mar 15; 60:910. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25416752 <Internet> http://cid.oxfordjournals.org/content/60/6/910
  8. ↑ 8.0 8.1 Grupping K, Campora L, Douha M, et al. Immunogenicity and safety of the HZ/su adjuvanted herpes zoster subunit vaccine in adults previously vaccinated with a live- attenuated herpes zoster vaccine. J Infect Dis 2017 Sep 26 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29029122 https://academic.oup.com/jid/article-abstract/doi/10.1093/infdis/jix482/4209275?redirectedFrom=fulltext
  9. ↑ 9.0 9.1 9.2 Dooling KL, Guo A, Patel M, et al. Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. MMWR Morb Mortal Wkly Rep 2018;67:103-108 https://www.cdc.gov/mmwr/volumes/67/wr/mm6703a5.htm
  10. ↑ 10.0 10.1 Tricco AC, Zarin W, Cardoso R et al Efficacy, effectiveness, and safety of herpes zoster vaccines in adults aged 50 and older: systematic review and network meta-analysis. BMJ 2018;363:k4029 PMID: https://www.ncbi.nlm.nih.gov/pubmed/30361202 Free full text https://www.bmj.com/content/363/bmj.k4029
  11. ↑ 11.0 11.1 Prosser LA, Harpaz R, Rose AM et al A Cost-Effectiveness Analysis of Vaccination for Prevention of Herpes Zoster and Related Complications: Input for National Recommendations. Ann Intern Med. 2019. Feb 19 PMID: https://www.ncbi.nlm.nih.gov/pubmed/30776797 https://annals.org/aim/article-abstract/2725147/cost-effectiveness-analysis-vaccination-prevention-herpes-zoster-related-complications-input
    Shafran SD Prevention of Shingles: Better Protection and Better Value With Recombinant Vaccine. Ann Intern Med. 2019. Feb 19 PMID: https://www.ncbi.nlm.nih.gov/pubmed/30776802 https://annals.org/aim/article-abstract/2725148/prevention-shingles-better-protection-better-value-recombinant-vaccine
  12. ↑ 12.0 12.1 Boutry C, Hastie A, Diez-Domingo J et al. The adjuvanted recombinant zoster vaccine confers long-term protection against herpes zoster: Interim results of an extension study of the pivotal phase III clinical trials (Zoe-50 And Zoe-70). Clin Infect Dis 2021 Jul 20; [e-pub] PMID: https://www.ncbi.nlm.nih.gov/pubmed/34283213 https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciab629/6324611
  13. ↑ 13.0 13.1 13.2 13.3 Medical Knowledge Self Assessment Program (MKSAP) 19 American College of Physicians, Philadelphia 2022
  14. ↑ 14.0 14.1 Geriatric Review Syllabus, 11th edition (GRS11) Harper GM, Lyons WL, Potter JF (eds) American Geriatrics Society, 2022
  15. ↑ 15.0 15.1 Douros A et al. Common vaccines and the risk of incident dementia: A population-based cohort study. J Infect Dis 2022 Dec 21; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36542511 https://academic.oup.com/jid/advance-article-abstract/doi/10.1093/infdis/jiac484/6948438
    Salmon DA et al. Commentary on "Common vaccines and the risk of dementia: a population-based cohort study": Science can be messy but eventually leads to truths. J Infect Dis 2022 Dec 21; [e-pub] PMID: https://www.ncbi.nlm.nih.gov/pubmed/36542509 https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiac487/6950650
  16. ↑ HIGHLIGHTS OF PRESCRIBING INFORMATION. SHINGRIX SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) Suspension for Intramuscular Injection https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Shingrix/pdf/SHINGRIX.PDF
  17. ↑ 17.0 17.1 Zerbo O et al Effectiveness of Recombinant Zoster Vaccine Against Herpes Zoster in a Real-World Setting. Ann Intern Med 2024. Jan 9 PMID: https://www.ncbi.nlm.nih.gov/pubmed/38190712 https://www.acpjournals.org/doi/10.7326/M23-2023
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