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recombinant Herpes zoster vaccine (Shingrix)

Indications: 1) prevention of shingles in the elderly - recombinant adjuvanted Herpes zoster vaccine (Shingrix) recommended for all adults >= 50 years [9]* - FDA-approved for immunodeficient & immunocompromised [2] 2) may lower risk of postherpetic neuralgia in elderly * regardless of previous immunization or prior infection [13] Contraindications: - pregnancy & breast feeding (relative contraindications) - not indicated for prevention of primary varicella virus infection (chickenpox) [14]* - does not reduce risk of dementia - may increase incidence of dementia in the elderly after a 2-year lag period [15] - may lower risk or delay onset of dementia [18] - 164 additional days at end of life without a diagnosis of dementia * safe for patients regardless of history of prior vaccination or infection [13] Benefit/risk: - Shingrix superior to Zostavax - number needed to treat (NNT) to prevent one episode of shingles - 11 when vaccinated at age 60 (Shingrix) [6] 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] - immunogenicity & safety profile of Shingrix similar in those previously vaccinated with Zostavax & vaccine-naive patients [8] - Shigrex more effective than Zostavax [10] - Shigrex more cost effective than Zostavax even when only 1 of 2 doses given [11] - GRS11 [14] recommends two doses IM 2-6 months apart regardless of prior immunization with Zostvax, failing to recognize refs [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: - contains recombinant varicella zoster virus glycoprotein E with a potent adjuvant Notes: - covered under Medicare part D of [14] - two-dose, adjuvanted herpes zoster subunit vaccine (Shingrix) is cost effective [3]

General

Herpes zoster (shingles) vaccine (Zostavax, Shingrix)

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 PMID: 27626517 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 PMID: 27626522 http://www.nejm.org/doi/full/10.1056/NEJMe1610652
  2. 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. 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: 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: 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. 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: 34724025 https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2785607
  6. 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 PMID: 25416754 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. PMID: 25416752 http://cid.oxfordjournals.org/content/60/6/910
  8. 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: 29029122 https://academic.oup.com/jid/article-abstract/doi/10.1093/infdis/jix482/4209275?redirectedFrom=fulltext
  9. 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. 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: 30361202 Free full text https://www.bmj.com/content/363/bmj.k4029
  11. 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: 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: 30776802 https://annals.org/aim/article-abstract/2725148/prevention-shingles-better-protection-better-value-recombinant-vaccine
  12. 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: 34283213 https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciab629/6324611
  13. Medical Knowledge Self Assessment Program (MKSAP) 19 American College of Physicians, Philadelphia 2022
  14. Geriatric Review Syllabus, 11th edition (GRS11) Harper GM, Lyons WL, Potter JF (eds) American Geriatrics Society, 2022 - Medicare.gov Shingles shots https://www.medicare.gov/coverage/shingles-shots
  15. 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: 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: 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. Zerbo O et al Effectiveness of Recombinant Zoster Vaccine Against Herpes Zoster in a Real-World Setting. Ann Intern Med 2024. Jan 9 PMID: 38190712 https://www.acpjournals.org/doi/10.7326/M23-2023
  18. Taquet M, Dercon Q, Todd JA, Harrison PJ. The recombinant shingles vaccine is associated with lower risk of dementia. Nat Med. 2024 Jul 25. PMID: 39053634 https://www.nature.com/articles/s41591-024-03201-5