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Zoster vaccine

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Zoster vaccine
Vaccine description
TargetHerpes zoster, postherpetic neuralgia, Ramsay Hunt syndrome type II, chickenpox
Vaccine typeLive attenuated (Zostavax), recombinant (Shingrix)
Clinical data
Trade namesZostavax, Shingrix
License data
Pregnancy
category
Routes of
administration		subcutaneous injection (Zostavax), intramuscular injection (Shingrix)
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only)[2]
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
Identifiers
DrugBank
ChemSpider
  • none
UNII
KEGG
  (verify)

Zoster vaccines are two vaccines that have been shown to reduce the rates of herpes zoster (also known as shingles). One type, Zostavax, is essentially a larger-than-normal dose of the chickenpox vaccine, as both shingles and chickenpox are caused by the same virus, the varicella zoster virus (VZV).[4][5] A recombinant version, Shingrix, was approved in the United States in 2017.[6]

While the recombinant version appears to prevent more cases of shingles, it has greater side effects and requires two doses.[7]

Medical uses

Zostavax

A Cochrane review concluded that Zostavax is "effective in preventing herpes zoster disease for up to three years".[8] The duration of protection beyond four years after vaccination with the zoster vaccine is unknown. The need for re-vaccination has not been defined.

Zostavax was shown to reduce the incidence of shingles by 51% in a study of 38,000 adults aged 60 and older who received the vaccine. 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%.[9][10][11] 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:[12][13]

  • 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,[14] and those who do not recall having had chickenpox, since more than 99% of Americans ages 40 and older have had chickenpox.[15]

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.[16]

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%).[17]

Side effects

Zostavax

The live vaccine (Zostavax) is very 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.[18][19] 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%).[20] 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.[18]

Zostavax should not be used in people with compromised immune function.[21][22]

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.[7][24]

Composition

The Zostavax vaccine contains live attenuated varicella-zoster virus.[18][25] It is injected subcutaneously (under the skin) in the upper arm.[26] The live vaccine was developed using the MRC-5 line of fetal stem cells.[11] This has raised religious and ethical concerns for some potential users, since that cell line was derived from an aborted fetus.[27]

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]

Society and culture

Cost effectiveness

In Canada the cost of Shingrix is about CA$300 for the two doses.[17]

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.[29] In 2007, the live vaccine was officially recommended in the U.S. for healthy adults aged 60 and over.[30][31]

Approval

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.[32][33] In 2007, the EMA updated the marketing authorization for routine vaccination in individuals aged 50 and over.[34][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.[35]

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.[36] 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.[37]

United States

Zostavax was developed by Merck & Co. and approved and licensed by the U.S. Food and Drug Administration (FDA) in May 2006,[9] In 2011, the FDA approved the live vaccine for use in individuals 50 to 59 years of age.[11][38] Shingrix is a zoster vaccine developed by GlaxoSmithKline that was approved in the United States in October 2017.[39]

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.[40] It was "no longer available for use in the United States, as of November 18, 2020." [41]

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.[42][43] Shingrix, which provides strong protection against shingles and PHN, is preferred over Zostavax.[44]

References

  1. ^ a b "Zoster vaccine live (Zostavax) Use During Pregnancy". Drugs.com. 3 January 2020. Retrieved 23 January 2020.
  2. ^ "Zostavax vaccine - Summary of Product Characteristics (SmPC)". (emc). 28 January 2019. Retrieved 6 September 2020.
  3. ^ "Zoster vaccine, inactivated (Shingrix) Use During Pregnancy". Drugs.com. 12 March 2018. Retrieved 23 January 2020.
  4. ^ Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, et al. (June 2005). "A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults". The New England Journal of Medicine. 352 (22): 2271–84. doi:10.1056/NEJMoa051016. PMID 15930418.
  5. ^ Oxman MN, Levin MJ, et al. (Shingles Prevention Study Group) (March 2008). "Vaccination against Herpes Zoster and Postherpetic Neuralgia". The Journal of Infectious Diseases. 197 (Suppl 2): S228–36. doi:10.1086/522159. PMC 4017882. PMID 18419402.
  6. ^ "Zoster Vaccine Recombinant, Adjuvanted" (PDF). U.S. Food and Drug Administration (FDA). Retrieved 7 November 2017.
  7. ^ a b 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.
  8. ^ Gagliardi, AM; Andriolo, BN; Torloni, MR; Soares, BG; de Oliveira Gomes, J; Andriolo, RB; Canteiro Cruz, E (7 November 2019). "Vaccines for preventing herpes zoster in older adults". Cochrane Database Syst Rev. 2019 (11). doi:10.1002/14651858.CD008858.pub4. PMC 6836378. PMID 31696946.
  9. ^ a b 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.
  10. ^ "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.
  11. ^ a b c "Zostavax- zoster vaccine live injection, powder, lyophilized, for suspension STERILE DILUENT- sterile water injection". DailyMed. 26 September 2019. Retrieved 6 September 2020.
  12. ^ "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.
  13. ^ "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.
  14. ^ "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.
  15. ^ Vaccines: VPD-VAC/Shingles/Shingles (Herpes zoster) Vaccination: What You Need to Know
  16. ^ "ACIP: New Vaccine Recommendations for Shingles Prevention". MPR. 25 October 2017. Retrieved 30 October 2017.
  17. ^ a b "[114] Shingrix: A New Vaccine for Shingles". Therapeutics Initiative. 11 October 2018. Retrieved 14 October 2018.
  18. ^ a b c "About Zostavax". Merck Sharp & Dohme Corp. May 2018. Retrieved 16 November 2018.
  19. ^ Harris S (18 January 2011). "Shingles Vaccine: Expert Q&A". WebMD. Retrieved 4 January 2014.
  20. ^ Cunha JP. "Zostavax Side Effects Center". RxList. Retrieved 4 January 2014.
  21. ^ "Zostavax vaccine". Therapeutic Goods Administration (TGA) (Press release). 7 March 2017. Retrieved 11 July 2020.
  22. ^ "Zostavax vaccine". Therapeutic Goods Administration (TGA) (Press release). 6 July 2020. Retrieved 11 July 2020.
  23. ^ a b c d "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. ^ "What everyone should know about Zostavax". Centers for Disease Control and Prevention, U.S. Department of Health & Human Services. 18 June 2018. Retrieved 16 November 2018.
  26. ^ "Shingles Vaccine (Zoster Shingles Vaccine Live, Zostavax)". Medicinenet.com. Retrieved 29 April 2018.
  27. ^ Davidson MW (13 November 2015). "Human Fetal Lung Fibroblast Cells (MRC-5 Line)". Florida State University.
  28. ^ "FDA Shingrix Briefing Document" (PDF). U.S. Food and Drug Administration (FDA). Retrieved 28 October 2017.
  29. ^ 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.
  30. ^ 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.
  31. ^ 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.
  32. ^ "Zostavax EPAR" (PDF). European Medicines Agency (EMA). July 2006. Retrieved 27 March 2011.
  33. ^ a b "Zostavax EPAR". European Medicines Agency (EMA). Retrieved 31 July 2020.
  34. ^ "Zostavax-H-C-674-II-03 Scientific Discussion" (PDF). 21 June 2007. Retrieved 27 March 2011.
  35. ^ "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.
  36. ^ "Shingles vaccine overview". Archived from the original on 2 June 2014. Retrieved 31 May 2014.
  37. ^ "Who can have the shingles vaccine?". Archived from the original on 10 April 2014. Retrieved 31 May 2014.
  38. ^ "FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age" (Press release). U.S. Food and Drug Administration (FDA). 24 March 2011. Archived from the original on 27 March 2011. Retrieved 27 March 2011.
  39. ^ "BBL approval" (PDF). U.S. Food and Drug Administration (FDA). 20 October 2017. Retrieved 29 April 2018.
  40. ^ https://www.merckvaccines.com/wp-content/uploads/sites/8/2020/06/US-CIN-00033.pdf
  41. ^ "What Everyone Should Know about Zostavax". U.S. CDC. Retrieved 10 December 2020.
  42. ^ Cimons, Marlene (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%.
  43. ^ "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...
  44. ^ "Shingles (Herpes Zoster) Vaccination". U.S. Centers for Disease Control and Prevention (CDC). 25 October 2018. Retrieved 18 January 2019.

Further reading

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