Zoster vaccine

Zoster vaccine
Vaccine description
Target disease Herpes zoster, postherpetic neuralgia, Ramsay Hunt syndrome type II, chickenpox
Type Attenuated virus
Clinical data
Pregnancy
category
  • US: C (Risk not ruled out)
Routes of
administration		 subcutaneous injection
ATC code J07BK02 (WHO)
Legal status
Legal status
  • ℞ (Prescription only)
Identifiers
ChemSpider none
  (verify)

Zoster vaccine (trade name Zostavax) is a live vaccine developed by Merck & Co. that has been shown to reduce the incidence of herpes zoster (known as shingles) by 51.3% in a study of 38,000 adults aged 60 and older who received the vaccine. The vaccine also reduced by 66.5% the number of cases of postherpetic neuralgia and reduced the severity and duration of pain and discomfort associated with shingles, by 61.1%. The zoster vaccine 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).[1][2]

Medical uses

A Cochrane review concluded that "Herpes zoster vaccine is effective in preventing herpes zoster disease and this protection can last three years".[3] The duration of protection beyond 4 years after vaccination with the zoster vaccine is unknown. The need for re-vaccination has not been defined.

United States

The zoster vaccine was approved and licensed by the U.S. Food and Drug Administration (FDA) in May 2006.[4][5][6] The FDA originally recommended it only for individuals 60 years of age or older who met the following requirements:[7][8]

On October 25, 2006, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend that the zoster vaccine be given to all adults age 60 and over, including those who have had a previous episode of shingles,[9] and those who do not recall having had chickenpox, since more than 99% of Americans ages 40 and older have had chickenpox.[10]

On March 24, 2011, the FDA approved the zoster vaccine for individuals 50 to 59 years of age.[6][11]

European Union

On May 19, 2006, the European Medicines Agency (EMEA) issued a marketing authorisation for the zoster vaccine to Sanofi Pasteur for routine vaccination in individuals aged 60 and over.[12] In 2007, the EMEA updated the marketing authorisation for routine vaccination in individuals aged 50 and over.[13]

United Kingdom

From 2013 the UK National Health Service started offering shingles vaccination to older 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.[14] The original intention was for people aged between 70 and 79 to be vaccinated,[15] but the NHS later said that the vaccination programme was being staggered as it would be impractical to vaccinate everyone in their 70s in a single year.[16]

Side effects

The zoster vaccine 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.[17][18]

In one study 64 percent of the Zostavax group and 14 percent of the controls had some adverse reaction. However, the rates of serious adverse events were comparable between the Zostavax group (0.6 percent) and those receiving the placebo (0.5 percent).[19]

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 into the same direction.[17]

Composition

The vaccine contains a minimum of 19,400 plaque-forming units (PFU) of the Oka/Merck strain of live, attenuated varicella-zoster virus. It is sterile and does not contain any preservatives.[17] It is injected subcutaneously (under the skin) in the upper arm.[20]

The vaccine was developed using the MRC-5 line of fetal stem cells.[21] This has raised ethical concerns for some potential users since that cell line was derived from an aborted fetus.[22]

References

  1. ↑ Oxman MN, Levin MJ, Johnson GR, et al. (June 2005). "A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults" (PDF). The New England Journal of Medicine. 352 (22): 2271–84. doi:10.1056/NEJMoa051016. PMID 15930418.
  2. ↑ Oxman MN; Levin MJ; Shingles Prevention Study Group (March 2008). "Vaccination against Herpes Zoster and Postherpetic Neuralgia" (PDF). The Journal of Infectious Diseases. 197 (Suppl 2): S228–36. doi:10.1086/522159. PMID 18419402.
  3. ↑ Gagliardi, AM; Andriolo, BN; Torloni, MR; Soares, BG (3 March 2016). "Vaccines for preventing herpes zoster in older adults.". The Cochrane database of systematic reviews. 3: CD008858. doi:10.1002/14651858.CD008858.pub3. PMID 26937872. Retrieved 8 March 2016.
  4. ↑ Mitka M. (July 2006). "FDA approves shingles vaccine: herpes zoster vaccine targets older adults" (PDF). JAMA. 296 (2): 157–8. doi:10.1001/jama.296.2.157. PMID 16835412.
  5. ↑ "FDA Licenses New Vaccine to Reduce Older Americans' Risk of Shingles" (Press release). Food and Drug Administration. May 26, 2006. Retrieved October 31, 2009.
  6. 1 2 Zostavax Full Prescribing Information. Merck & Co. March 2011.
  7. ↑ "Patient Information (Text) about Zostavax-May 2006". Food and Drug Administration. May 2006. Archived from the original on June 19, 2009. Retrieved October 31, 2009.
  8. ↑ "Patient Information about Zostavax (Text) 12/2008". Food and Drug Administration. December 2008. Retrieved October 31, 2009.
  9. ↑ "CDC's Advisory Committee Recommends "Shingles" Vaccination" (Press release). U.S. Centers for Disease Control and Prevention (CDC). October 26, 2006. Retrieved October 31, 2009.
  10. ↑ Vaccines: VPD-VAC/Shingles/Shingles (Herpes zoster) Vaccination: What You Need to Know
  11. ↑ "FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age" (Press release). U.S. Food and Drug Administration (FDA). March 24, 2011. Retrieved March 27, 2011.
  12. ↑ "Zostavax European Public Assessment Report" (PDF). European Medicines Agency (EMEA). July 2006. Retrieved March 27, 2011.
  13. ↑ "Zostavax-H-C-674-II-03 Scientific Discussion" (PDF). June 21, 2007. Retrieved March 27, 2011.
  14. ↑ NHS:Shingles vaccination, 2013
  15. ↑ Pulse:GPs given green light to start shingles vaccination, 2 November 2012
  16. ↑ NHS: Who can have the shingles vaccine?
  17. 1 2 3 http://www.vaccines.mil/documents/shingles_qa.pdf
  18. ↑ Harris, Scott (January 18, 2011). "Never Too Late to Seek Protection Against 'Debilitating' Virus". WebMD. Retrieved 4 January 2014.
  19. ↑ Cunha, John P. "Zostavax Side Effects Center". RxList. Retrieved 4 January 2014.
  20. ↑ http://www.medicinenet.com/zoster_vaccine_live__shingles_vaccine/article.htm
  21. ↑ http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM132831.pdf
  22. ↑ http://micro.magnet.fsu.edu/primer/techniques/fluorescence/gallery/cells/mrc5/mrc5cells.html
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