Zoster vaccine

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Zoster vaccine
Shingrix.jpg
Shingrix (one of two types of zoster vaccines)
Vaccine description
Target diseaseHerpes zoster, postherpetic neuralgia[1]
TypeShingrix (recombinant protein subunit)
Zostavax (attenuated)
Names
Trade namesShingrix, Zostavax
Other namesZoster vaccine recombinant (RZV)
Zoster vaccine live (ZVL)
Clinical data
Pregnancy
category
Routes of
use
Shingrix (intramuscular injection)
Zostavax (subcutaneous injection)
External links
AHFS/Drugs.comShingrix Monograph
Zostavax Monograph
US NLMZoster vaccine
Legal
License data
Legal status
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only) [4]
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
  (verify)

Zoster vaccines, of which there are two types Shingrix and Zostavax, are vaccines that reduce the risk of herpes zoster (shingles) and postherpetic neuralgia, diseases caused by reactivation of the varicella zoster virus (VZV), which is also responsible for chickenpox.[1] Shingrix appears to prevent more cases of shingles than Zostavax, although side effects are more frequent and it requires two doses.[5][6] They are approved for use in people over 50 years old.[1] They are given by injection.[7][8]

Shingrix is a recombinant subunit vaccine.[5] Zostavax is an live attenuated vaccine which basically consists of a larger-than-normal dose of chickenpox vaccine.[1][9] Unlike Shingrix, Zostavax is not suitable for people with immunosuppression or who are pregnant.[1][10] The side effects of both vaccines are generally mild to moderate and can include pain at the site of injection, tiredness, and headache.[6][7][8]

Shingrix was approved for medical use in the United States in 2017 while Zostavax was approved for medical use in in 2006.[11] In the United States Shingrix costs 310 USD for two dose as of 2021.[12] In the United Kingdom a dose of Zostavax costs the NHS about £100.[13] As of 2020, Zostavax is no longer available in the United States.[10]

Medical uses

Zoster vaccination is used to prevent shingles and its complications, including postherpetic neuralgia.[1][9] It can be considered a therapeutic vaccine, given that it is used to treat a latent virus that has remained dormant in cells since chicken pox infection earlier in life.[9] The two available zoster vaccines are intended for use in people over the age of 50.[1] Booster doses are not indicated for either vaccine, since there is little evidence of any significant reduction in immunity in the years following vaccination.[5][9]

Shingrix

The Advisory Committee on Immunization Practices (ACIP) in the United States recommends Shingrix for adults over the age of 50, including those who have already received Zostavax. The Committee voted that Shingrix is preferred over Zostavax for the prevention of zoster and related complications because data showed vaccine efficacy of more than 90% against shingles across all age groups, as well as sustained efficacy over a 4-year follow-up. Unlike Zostavax, which is given as a single shot, Shingrix is given as two intramuscular doses, two to six months apart.[14]

The absolute decrease in risk of herpes zoster following immunization over three and a half years is 3.3% (3.54% down to 0.28%) while the decrease in the risk of postherpetic neuralgia is 0.3% (0.34% down to 0.06%).[15]

Zostavax

Zostavax (UK)

Zostavax is a live attenuated vaccine given in the UK to adults over the age of 70 to prevent shingles.[13] It is given by subcutaneous injection or intramuscular injection in the upper arm.[13] Due to a rare chance of transmitting the varicella-zoster virus to another person, if a rash appears within 6 weeks of the vaccine, the person should keep away from pregnant women and people with weakened immune systems.[13] It is not given to people who are immunocompromised.[13] It can be given on the same day as the MMR vaccine or with a 4 week interval.[13] As of 2020, Zostavax is no longer available in the United States.[10]

Zostavax is effective in preventing zoster for up to three years.[6] The duration of protection beyond four years after vaccination is unknown. The need for re-vaccination has not been defined.[medical citation needed]

Zostavax was shown to reduce the risk of shingles by 50% in those aged 60 and older. The vaccine also reduced by 67% the number of cases of postherpetic neuralgia (PHN) and reduced the severity and duration of pain and discomfort associated with shingles, by 61%.[16][17][18] The FDA originally recommended it for individuals 60 years of age or older who are not severely allergic to any of its components and who meet the following requirements:[19][20]

  • does not have a weakened immune system due to HIV/AIDS or another disease or medications (such as steroids, radiation and chemotherapy) that affect the immune system;
  • does not have a history of cancer affecting the bone marrow or lymphatic system, such as leukemia or lymphoma; and
  • does not have active, untreated tuberculosis.

In 2006, the U.S. Advisory Committee on Immunization Practices (ACIP) recommended that the live vaccine be given to all adults age 60 and over, including those who have had a previous episode of shingles,[21] and those who do not recall having had chickenpox, since more than 99% of Americans ages 40 and older have had chickenpox.[22]

Side effects

Shingrix

Temporary side effects from the Shingrix shots are likely, and can be severe enough in one out of six people to affect normal daily activities for up to three days.[23] Mild to moderate pain at the injection site is common, and some may have redness or swelling.[23] Side effects include fatigue, muscle pain, headache, shivering, fever, and nausea.[23] Symptoms usually resolve in two to three days.[23] Side effects with Shingrix are greater than those with Zostavax and occur more frequently in individuals aged 50 to 69 years compared with those 70 years and older.[5][24]

Zostavax

The live vaccine (Zostavax) is generally safe; one to a few percent of people develop a mild form of chickenpox, often with about five or six blisters around the injection site, and without fever. The blisters are harmless and temporary.[25][26] In one study 64% of the Zostavax group and 14% of the controls had some adverse reaction. However, the rates of serious adverse events were comparable between the Zostavax group (0.6%) and those receiving the placebo (0.5%).[27] A study including children with leukaemia found that the risk of getting shingles after vaccination is much lower than the risk of getting shingles for children with natural chicken pox in their history. Data from healthy children and adults point in the same direction.[25] Uncommon side effects include cough and sleepiness.[13] Rare side effects include conjunctivitis, Kawasaki disease, stroke, seizures, low platelets or vasculitis.[13]

Composition

Shingrix

Shingrix is a suspension for intramuscular injection consisting of a lyophilized recombinant varicella zoster virus (VZV) glycoprotein E (gE) antigen that is reconstituted at the time of use with AS01B suspension as an immunological adjuvant. The antigen is a purified truncated form of the glycoprotein, expressed in Chinese hamster ovary cells. The AS01B adjuvant suspension is composed of 3-O-desacyl-4'- monophosphoryl lipid A (MPL) from Salmonella (Minnesota strain) and a saponin molecule (QS-21) purified from Quillaja saponaria (soap bark tree) extract, combined in a liposomal formulation consisting of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate-buffered saline solution.[28]

Zostavax

The Zostavax vaccine contains live attenuated varicella-zoster virus.[25][10] The live vaccine is produced using the MRC-5 line of fetal cells.[18] This has raised religious and ethical concerns for some potential users, since that cell line was derived from an aborted fetus.[29]

History

The reasoning for vaccinating older adults against zoster stems from the observations of British general practitioner R. E. Hope-Simpson published in 1965 that the immunity conferred by natural chicken-pox in childhood waned with age.[30]

European Union

In 2006, the European Medicines Agency (EMA) issued a marketing authorization for the zoster vaccine to Sanofi Pasteur for routine vaccination in individuals aged 60 and over.[31][32] In 2007, the EMA updated the marketing authorization for routine vaccination in individuals aged 50 and over.[32][33]

Shingrix was approved for medical use in the European Union in March 2018, with an indication for the prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in adults 50 years of age or older.[34]

United Kingdom

From 2013, the UK National Health Service (NHS) started offering shingles vaccination to elderly people. People aged either 70 or 79 on 1 September 2013, were offered the vaccine. People aged 71 to 78 on that date would only have an opportunity to have the shingles vaccine after reaching the age of 79.[35] The original intention was for people aged between 70 and 79 to be vaccinated, but the NHS later said that the vaccination program was being staggered as it would be impractical to vaccinate everyone in their 70s in a single year.[36]

United States

Zostavax was developed by Merck & Co. and approved and licensed by the U.S. Food and Drug Administration (FDA) in May 2006,[16] In 2011, the FDA approved the live vaccine for use in individuals 50 to 59 years of age.[18][37] Shingrix is a zoster vaccine developed by GlaxoSmithKline that was approved in the United States in October 2017.[38]

As of June 30, 2020, Merck discontinued the sale of Zostavax in the U.S. market. Existing vaccine already in the hands of practitioners, none having expiration dates later than November 2020, could still be administered up to the expiration date.[39] As of November 2020, Zostavax is not available in the United States.[10]

The U.S. Centers for Disease Control and Prevention (CDC) recommends that healthy adults 50 years and older get two doses of Shingrix, at least two months apart. Initial clinical trials only tested a gap of less than six months between doses, but unexpected popularity and resulting shortages caused further testing to validate wider spacing of the two doses.[40][41] Shingrix, which provides strong protection against shingles and PHN, is preferred over Zostavax.[42]

The zoster vaccine is covered by Medicare Part D. More than 90% of Medicare Part D vaccine spending is for the zoster vaccine.[43] In 2019, 5.8 million vaccine doses were administered to Part D beneficiaries at a cost of $857 million.

Society and culture

Cost

In Canada the cost of Shingrix is about CA$300 for the two doses.[15]

A 2007 study found that the live vaccine is likely to be cost-effective in the U.S., projecting an annual savings of US$82 to US$103 million in healthcare costs with cost-effectiveness ratios ranging from US$16,229 to US$27,609 per quality-adjusted life year gained.[44] In 2007, the live vaccine was officially recommended in the U.S. for healthy adults aged 60 and over.[45][46]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 Saguil A, Kane S, Mercado M, Lauters R (November 2017). "Herpes zoster and postherpetic neuralgia: prevention and management". American Family Physician. 96 (10): 656–663. PMID 29431387.
  2. 2.0 2.1 "Zoster vaccine live (Zostavax) Use During Pregnancy". Drugs.com. 3 January 2020. Retrieved 23 January 2020.
  3. "Zoster vaccine, inactivated (Shingrix) Use During Pregnancy". Drugs.com. 12 March 2018. Retrieved 23 January 2020.
  4. "Zostavax vaccine - Summary of Product Characteristics (SmPC)". (emc). 28 January 2019. Retrieved 6 September 2020.
  5. 5.0 5.1 5.2 5.3 Tricco AC, Zarin W, Cardoso R, Veroniki AA, Khan PA, Nincic V, et al. (October 2018). "Efficacy, effectiveness, and safety of herpes zoster vaccines in adults aged 50 and older: systematic review and network meta-analysis". BMJ. 363: k4029. doi:10.1136/bmj.k4029. PMC 6201212. PMID 30361202.
  6. 6.0 6.1 6.2 Gagliardi AM, Andriolo BN, Torloni MR, et al. (November 2019). "Vaccines for preventing herpes zoster in older adults". The Cochrane Database of Systematic Reviews. 2019 (11). doi:10.1002/14651858.CD008858.pub4. PMC 6836378. PMID 31696946.
  7. 7.0 7.1 "Zoster Vaccine Recombinant Monograph for Professionals". Drugs.com. Retrieved 5 August 2021.
  8. 8.0 8.1 "Zoster Vaccine Live Monograph for Professionals". Drugs.com. Retrieved 5 August 2021.
  9. 9.0 9.1 9.2 9.3 Gershon AA, Breuer J, Cohen JI, Cohrs RJ, Gershon MD, Gilden D, et al. (July 2015). "Varicella zoster virus infection". Nature Reviews. Disease Primers. 1: 15016. doi:10.1038/nrdp.2015.16. PMC 5381807. PMID 27188665.
  10. 10.0 10.1 10.2 10.3 10.4 "Shingles Zostavax Vaccination | What You Should Know | CDC". www.cdc.gov. 25 February 2021. Retrieved 5 August 2021.
  11. "Varicella and herpes zoster vaccines: WHO position paper, June 2014" (PDF). Releve epidemiologique hebdomadaire. 89 (25): 265–87. 20 June 2014. PMID 24983077.
  12. "Shingrix Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 5 August 2021.
  13. 13.0 13.1 13.2 13.3 13.4 13.5 13.6 13.7 "14. Vaccines". British National Formulary (BNF) (82 ed.). London: BMJ Group and the Pharmaceutical Press. September 2022 – March 2022. pp. 1393–1394. ISBN 978-0-85711-413-6.
  14. Han, Da Hee (25 October 2017). "ACIP: New Vaccine Recommendations for Shingles Prevention". MPR. Retrieved 30 October 2017.
  15. 15.0 15.1 "[114] Shingrix: A New Vaccine for Shingles". Therapeutics Initiative. 11 October 2018. Retrieved 14 October 2018.
  16. 16.0 16.1 Mitka M (July 2006). "FDA approves shingles vaccine: herpes zoster vaccine targets older adults". JAMA. 296 (2): 157–8. doi:10.1001/jama.296.2.157. PMID 16835412.
  17. "FDA Licenses New Vaccine to Reduce Older Americans' Risk of Shingles" (Press release). U.S. Food and Drug Administration (FDA). 26 May 2006. Retrieved 31 October 2009.
  18. 18.0 18.1 18.2 "Zostavax- zoster vaccine live injection, powder, lyophilized, for suspension STERILE DILUENT- sterile water injection". DailyMed. 26 September 2019. Retrieved 6 September 2020.
  19. "Patient Information (Text) about Zostavax-May 2006". U.S. Food and Drug Administration (FDA). May 2006. Archived from the original on 19 June 2009. Retrieved 31 October 2009.
  20. "Patient Information about Zostavax (Text) 12/2008". U.S. Food and Drug Administration (FDA). December 2008. Archived from the original on 27 August 2009. Retrieved 31 October 2009.
  21. "CDC's Advisory Committee Recommends "Shingles" Vaccination" (Press release). U.S. Centers for Disease Control and Prevention (CDC). 26 October 2006. Retrieved 31 October 2009.
  22. Vaccines: VPD-VAC/Shingles/Shingles (Herpes zoster) Vaccination: What You Need to Know
  23. 23.0 23.1 23.2 23.3 "Shingrix shingles vaccination: What you should know". CDC. 28 February 2018. Retrieved 29 April 2018.
  24. "Shingrix- zoster vaccine recombinant, adjuvanted kit". DailyMed. 4 October 2019. Retrieved 6 September 2020.
  25. 25.0 25.1 25.2 "About Zostavax". Merck Sharp & Dohme Corp. May 2018. Retrieved 16 November 2018.
  26. Harris S (18 January 2011). "Shingles Vaccine: Expert Q&A". WebMD. Retrieved 4 January 2014.
  27. Cunha, John P. "Zostavax Side Effects Center". RxList. Retrieved 4 January 2014.
  28. "FDA Shingrix Briefing Document" (PDF). U.S. Food and Drug Administration (FDA). Retrieved 28 October 2017.
  29. Davidson MW (13 November 2015). "Human Fetal Lung Fibroblast Cells (MRC-5 Line)". Florida State University.
  30. Harbecke, Ruth; Cohen, Jeffrey I.; Oxman, Michael N. (30 September 2021). "Herpes Zoster Vaccines". The Journal of Infectious Diseases. 224 (Supplement_4): S429–S442. doi:10.1093/infdis/jiab387. ISSN 1537-6613. PMID 34590136.
  31. "Zostavax EPAR" (PDF). European Medicines Agency (EMA). July 2006. Retrieved 27 March 2011.
  32. 32.0 32.1 "Zostavax EPAR". European Medicines Agency (EMA). Retrieved 31 July 2020.
  33. "Zostavax-H-C-674-II-03 Scientific Discussion" (PDF). 21 June 2007. Retrieved 27 March 2011.
  34. "Shingrix EPAR". European Medicines Agency (EMA). Retrieved 31 July 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
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  36. "Who can have the shingles vaccine?". Archived from the original on 10 April 2014. Retrieved 31 May 2014.
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  38. "BBL approval" (PDF). U.S. Food and Drug Administration (FDA). 20 October 2017. Retrieved 29 April 2018.
  39. "Product Discontinuation Notice: Zostavax (Zoster Vaccine Live)" (PDF). Archived from the original (PDF) on 18 August 2020.
  40. Cimons M (29 July 2018). "Don't panic if you're put on a waiting list for the new shingles vaccine". The Washington Post. Retrieved 24 January 2020. The Centers for Disease Control and Prevention, which issues vaccine recommendations, says patients who wait longer than six months needn't worry, but they should get that second dose as soon as possible. Be sure not to skip it, because two doses convey the maximum immunity, more than 90%.
  41. "Frequently Asked Questions About Shingrix". U.S. Centers for Disease Control and Prevention (CDC). 26 March 2018. Retrieved 23 January 2020. You and patients should make every effort to ensure that two doses are administered within the recommended 2-6 month interval. If more than 6 months have elapsed since the first dose, administer the second dose as soon as possible. Do not restart the vaccine series...
  42. "Shingles (Herpes Zoster) Vaccination". U.S. Centers for Disease Control and Prevention (CDC). 25 October 2018. Retrieved 18 January 2019.
  43. Report to the Congress: Medicare and the Health Care Delivery System (PDF). Medicare Payment Advisory Commission. June 2021. p. 254.
  44. Pellissier JM, Brisson M, Levin MJ (2007). "Evaluation of the cost-effectiveness in the United States of a vaccine to prevent herpes zoster and postherpetic neuralgia in older adults". Vaccine. 25 (49): 8326–37. doi:10.1016/j.vaccine.2007.09.066. PMID 17980938.
  45. Harpaz R, Ortega-Sanchez IR, Seward JF (June 2008). "Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP)" (PDF). MMWR Recomm. Rep. 57 (RR–5): 1–30, quiz CE2–4. PMID 18528318.
  46. Advisory Committee on Immunization Practices (20 November 2007). "Recommended adult immunization schedule: United States, October 2007 – September 2008". Annals of Internal Medicine. 147 (10): 725–29. doi:10.7326/0003-4819-147-10-200711200-00187. PMID 17947396. S2CID 31630647.

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