Herpes zoster (shingles) vaccine (Zostavax, Shingrix)
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Introduction
Tradenames:
Indications
- prevention of shingles in the elderly
- recombinant adjuvanted Herpes zoster vaccine (Shingrix) recommended for all adults >= 50 years[32]
- may lower risk of postherpetic neuralgia in elderly]
- vaccine likely effective & safe in patients taking biologic response modifiers for autoimmune disease (Zostavax)[18]
- effective (41%) in patients vaccinated prior to chemotherapy (Zostavax)[22]
- Zostavax may reduce new diagnosis of dementia within 7 years (RR=0.8)[43]
* above
Contraindications
- Zostavax
- immunocompromised patients
- lymphoma[21]
- HIV1[21]
- chemotherapy for cancer
- treatment with immunosuppressive agents
- >= 20 mg of prednisone/day (ACIP)
- safe for patients with immune-related diagnoses such as rheumatoid arthritis or inflammatory bowel disease[15]
- safe for patients treated with biologic immunosuppressive agents, including TNF-alpha inhibitors[17]
- tuberculosis[13]
- see live virus vaccine
- symptomatic shingles or active postherpetic neuralgia[12][13]
- no need to ask about varicella exposure or check a varicella titer[13]
- allergy to neomycin or gelatin[13]
- secondary prevention of shingles ?
- immunocompromised patients
- Shingrix
- Shingrix may be safe for immunocompromised patients[34]
- Shingrix effective after autologous stem cell transplantation[38]
Benefit/risk
- Zostavax
- number needed to treat (NNT) to prevent one episode of shingles = 71[10], 17[13], 11[23]; 40 when vaccinated at age 50[25];] 13 when vaccinated at age 50[29];
- NNT to prevent one case of post-herpetic neuralgia = 43[11], 31[13]
- NNT to prevent one case of post-herpetic neuralgia when vaccinated at age 50 = 1000[25]
- NNT to prevent one Herpes zoster-related death = 3762[11]
- no difference in recurrence of shingles in vaccinated vs unvaccinated individuals[16]
- risk to benefit ratio uncertain
- vaccination equally common among cases & controls[26]
- Zostavax may reduce >= 3 year incidence of dementia[41]
- Zostavax may reduce of Alzheimer's Disease, Parkinson's Disease & 0ther neurodegenerative disorders[42]
- Shingrix superior to Zostavax
- number needed to treat (NNT) to prevent one episode of shingles
Dosage
* Shingrix also recommended (1 dose) after Zostvax[29][32]
- immunogenicity & safety profile of Shingrix similar in those previously vaccinated with Zostavax & vaccine-naive patients[30]
- Shigrex more effective than Zostavax[35]
- Shigrex more cost effective than Zostavax even when only 1 of 2 doses given[37]
- GRS11[17] recommends two doses IM 2-6 months apart regardless of prior immunization with Zostvax, failing to recognize refs[29][32]
Keep frozen (< -15 degrees C), reconstitute & use immediately. 19,400 plaque forming units per dose
Pharmacokinetics
- after 10 years, Zostavax largely ineffective[24]
- overall estimates of Zostavax efficacy between 5-12 years after vaccination are 21% against incidence of shingles, 35% against postherpetic neuralgia[24]
- Shingrix reportedly 84% effective after 5-7 years[39]
Adverse effects
- 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[36]
- risk of Guillain-Barre syndrome is low (10 excess cases per 1 million vaccinations in one analysis)[40]
Drug interactions
- labeling suggests spacing Zostavax & pneumococcal vaccines 4 weeks apart, but CDC does NOT advocate waiting[12]
Mechanism of action
- live virus vaccine (Zostavax)
- Shingrix is a recombinant herpes zoster glycoprotein combined with adjuvant, not a live virus vaccine[34]
Notes
- Zostavax cost is about $150 (2006)
- covered under part D of Medicare[13]
- may not be cost-effective[4]
- vaccine efficacy may wane with time[19]
- two-dose, adjuvanted herpes zoster subunit vaccine (Shingrix) is cost effective[31]
More general terms
More specific terms
Additional terms
References
- ↑ Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, Arbeit RD, Simberkoff MS, Gershon AA, Davis LE, Weinberg A, Boardman KD, Williams HM, Zhang JH, Peduzzi PN, Beisel CE, Morrison VA, Guatelli JC, Brooks PA, Kauffman CA, Pachucki CT, Neuzil KM, Betts RF, Wright PF, Griffin MR, Brunell P, Soto NE, Marques AR, Keay SK, Goodman RP, Cotton DJ, Gnann JW Jr, Loutit J, Holodniy M, Keitel WA, Crawford GE, Yeh SS, Lobo Z, Toney JF, Greenberg RN, Keller PM, Harbecke R, Hayward AR, Irwin MR, Kyriakides TC, Chan CY, Chan IS, Wang WW, Annunziato PW, Silber JL; Shingles Prevention Study Group. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005 Jun 2;352(22):2271-84. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15930418
- ↑ 2.0 2.1 Prescriber's Letter 12(7): 2005 Vaccination for Herpes Zoster and Postherpetic Neuralgia Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=210712&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Prescriber's Letter 13(7): 2006 Herpes Zoster (Zostavax) Vaccine Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220702&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 4.0 4.1 Hornberger J and Robertus K Cost-effectiveness of a vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. Ann Intern Med 2006, 145:317 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16954357
Koplan JP & Harpaz R Shingles vaccine: Effective and costly or cost-effective? Ann Intern Med 2006, 145:386 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16954362 - ↑ Prescriber's Letter 13(12): 2006 Issues with Herpes Zoster (Zosatvax) Vaccine Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=221201&pb=PRL (subscription needed) http://www.prescribersletter.com http://www.cdc.gov/nip/publications/VIS/vis-shingles.pdf
- ↑ Kimberlin DW & Whitley RJ Varicella-zoster vaccine for the prevention of herpes zoster. N Engl J Med 2007, 356:1338 PMID: https://www.ncbi.nlm.nih.gov/pubmed/17392303
Chaves SS et al, Loss vaccine-induced immunity to varicella overtime. N Engl J Med 2007, 356:1121 PMID: https://www.ncbi.nlm.nih.gov/pubmed/17360990 - ↑ Prescriber's Letter 15(1): 2008 Reimbursement for Medicare Part D-Covered Vaccines Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=240113&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008 Jun 6;57(RR-5):1-30; quiz CE2-4. PMID: https://www.ncbi.nlm.nih.gov/pubmed/18528318
- ↑ Simberkoff MS et al Safety of herpes zoster vaccine in the shingles prevention study: A randomized trial. Ann Intern Med 2010 May 4; 152:545. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/20439572 <Internet> http://dx.doi.org/10.1059/0003-4819-152-9-201005040-00004
Hurley LP et al. Barriers to the use of herpes zoster vaccine. Ann Intern Med 2010 May 4; 152:555. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/20439573 <Internet> http://dx.doi.org/10.1059/0003-4819-152-9-201005040-00005
Donahue JG and Belongia EA. The looming rash of herpes zoster and the challenge of adult immunization. Ann Intern Med 2010 May 4; 152:609. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/20439578 <Internet> http://dx.doi.org/10.1059/0003-4819-152-9-201005040-00011 - ↑ 10.0 10.1 Tseng HF et al Herpes Zoster Vaccine in Older Adults and the Risk of Subsequent Herpes Zoster Disease JAMA. 2011;305(2):160-166 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21224457 <Internet> http://jama.ama-assn.org/content/305/2/160.short
- ↑ 11.0 11.1 11.2 FDA NEWS RELEASE: March 24, 2011 FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm248390.htm
- ↑ 12.0 12.1 12.2 Prescriber's Letter 19(1): 2012 Lower Age Limit for Zostavax (Herpes Zoster Vaccine) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=280118&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 13.0 13.1 13.2 13.3 13.4 13.5 13.6 13.7 Geriatric Review Syllabus, 7th edition Parada JT et al (eds) American Geriatrics Society, 2010
Geriatric Review Syllabus, 8th edition (GRS8) Durso SC and Sullivan GN (eds) American Geriatrics Society, 2013
Geriatric Review Syllabus, 9th edition (GRS9) Medinal-Walpole A, Pacala JT, Porter JF (eds) American Geriatrics Society, 2016
Medicare.gov Shingles shots https://www.medicare.gov/coverage/shingles-shots - ↑ Schmader KE et al. Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years. Clin Infect Dis 2012 Apr 1; 54:922. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22291101
Li H-T et al. Herpes zoster vaccination in people aged 50-59 years. Clin Infect Dis 2012 Apr 1; 54:929. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22291101 - ↑ 15.0 15.1 Zhang J, Xie F, Delzell E et al Association Between Vaccination for Herpes Zoster and Risk of Herpes Zoster Infection Among Older Patients With Selected Immune-Mediated Diseases JAMA. 2012;308(1):43-49 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22760290 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=1212306
- ↑ 16.0 16.1 16.2 Tseng HF et al. Herpes zoster vaccine and the incidence of recurrent herpes zoster in an immunocompetent elderly population. J Infect Dis 2012 Jul 15; 206:190. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22669900
- ↑ 17.0 17.1 17.2 Geriatric Review Syllabus, 9th edition (GRS9) Medinal-Walpole A, Pacala JT, Porter JF (eds) American Geriatrics Society, 2016
Geriatric Review Syllabus, 11th edition (GRS11) Harper GM, Lyons WL, Potter JF (eds) American Geriatrics Society, 2022 - ↑ 18.0 18.1 Medical Knowledge Self Assessment Program (MKSAP) 17, American College of Physicians, Philadelphia 2015
- ↑ 19.0 19.1 Schmader KE et al. Persistence of the efficacy of zoster vaccine in the shingles prevention study and the short-term persistence substudy. Clin Infect Dis 2012 Nov 15; 55:1320. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22828595
- ↑ 20.0 20.1 Oxman MN. Zoster vaccine: current status and future prospects. Clin Infect Dis. 2010 Jul 15;51(2):197-213 PMID: https://www.ncbi.nlm.nih.gov/pubmed/20550454
- ↑ 21.0 21.1 21.2 Forbes HJ et al Quantification of risk factors for herpes zoster: population based case-control study. BMJ 2014;348:g2911 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25134101 <Internet> http://www.bmj.com/content/348/bmj.g2911
- ↑ 22.0 22.1 Tseng HF et al. Vaccination against zoster remains effective in older adults who later undergo chemotherapy. Clin Infect Dis 2014 Oct 1; 59:913. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25097079 <Internet> http://cid.oxfordjournals.org/content/59/7/913
Oxman MN and Schmader KE. Zoster vaccine in immunocompromised patients: Time to reconsider current recommendations. Clin Infect Dis 2014 Oct 1; 59:920. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25097080 <Internet> http://cid.oxfordjournals.org/content/59/7/920 - ↑ 23.0 23.1 Brisson M. Estimating the number needed to vaccinate to prevent herpes zoster-related disease, health care resource use and mortality. Can J Public Health. 2008 Sep-Oct;99(5):383-6. PMID: https://www.ncbi.nlm.nih.gov/pubmed/19009921
- ↑ 24.0 24.1 24.2 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 - ↑ 25.0 25.1 25.2 Le P, Rothberg MB Cost-Effectiveness of Herpes Zoster Vaccine for Persons Aged 50 Years. Ann Intern Med. Published online 8 September 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26344036 <Internet> http://annals.org/article.aspx?articleid=2434619
- ↑ 26.0 26.1 Kwon HJ et al. Asthma as a risk factor for zoster in adults: A population- based case-control study. J Allergy Clin Immunol 2015 Dec 11 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26739414 <Internet> http://www.jacionline.org/article/S0091-6749%2815%2901641-3/abstract
- ↑ Langan SM, Smeeth L, Margolis DJ, Thomas SL. Herpes zoster vaccine effectiveness against incident herpes zoster and post-herpetic neuralgia in an older US population: a cohort study. PLoS Med. 2013;10(4):e1001420. Epub 2013 Apr 9. PMID: https://www.ncbi.nlm.nih.gov/pubmed/23585738 Free PMC Article
- ↑ Centers for Disease Control and Prevention (CDC). Update on herpes zoster vaccine: licensure for persons aged 50 through 59 years. MMWR Morb Mortal Wkly Rep. 2011 Nov 11;60(44):1528. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22071592
- ↑ 29.0 29.1 29.2 29.3 29.4 29.5 29.6 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
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 - ↑ 30.0 30.1 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
- ↑ 31.0 31.1 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 - ↑ 32.0 32.1 32.2 32.3 32.4 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
- ↑ 33.0 33.1 Shimabukuro TT, Miller ER, Strikas RA, et al. Notes from the Field: Vaccine Administration Errors Involving Recombinant Zoster Vaccine - United States, 2017-2018. MMWR Morb Mortal Wkly Rep 2018;67:585-586 https://www.cdc.gov/mmwr/volumes/67/wr/mm6720a4.htm
- ↑ 34.0 34.1 34.2 Zuger A New Shingles Vaccine is here! NEJM Journal Watch. Jan 1, 2018. pg 8 Massachusetts Medical Society (subscription needed) http://www.jwatch.org
- ↑ 35.0 35.1 35.2 35.3 35.4 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
- ↑ 36.0 36.1 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
- ↑ 37.0 37.1 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 - ↑ 38.0 38.1 Bastidas A, de la Serna J, El Idrissi M et al Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell TransplantationA Randomized Clinical Trial. JAMA. 2019;322(2):123-133 PMID: https://www.ncbi.nlm.nih.gov/pubmed/31287523 https://jamanetwork.com/journals/jama/fullarticle/2737683
- ↑ 39.0 39.1 39.2 39.3 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
- ↑ 40.0 40.1 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
- ↑ 41.0 41.1 Lophatananon A, Mekli K, Cant R et aL Shingles, Zostavax vaccination and risk of developing dementia: a nested case-control study-results from the UK Biobank cohort. BMJ Open. 2021 Oct 8;11(10):e045871 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34625411 PMCID: PMC8504358 Free PMC article
- ↑ 42.0 42.1 Lehrer S, Rheinstein PH Vaccination Reduces Risk of Alzheimer's Disease, Parkinson's Disease and Other Neurodegenerative Disorders. Discov Med. 2022 Sep-Oct;34(172):97-101. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36281030 PMCID: PMC9608336 Free PMC article
- ↑ 43.0 43.1 Reardon S Does shingles vaccination cut dementia risk? Large study hints at a link. Analysis of nearly 300,000 people finds an association between the shingles jab and a lower rate of dementia - but questions linger. Nature. 2023. June 6 https://www.nature.com/articles/d41586-023-01824-1
Eyting M et al Causal evidence that herpes zoster vaccination prevents a proportion of dementia cases. MedRxiv. 2023. May 25. https://www.medrxiv.org/content/10.1101/2023.05.23.23290253v1