Zoster vaccine

Zoster vaccine
Vaccine description
Target disease Herpes zoster, postherpetic neuralgia, Ramsay Hunt syndrome type II, chickenpox
Clinical data
Trade names Zostavax, Shingrix
License data
Pregnancy
category
  • US: C (Risk not ruled out)
    Routes of
    administration    		 subcutaneous injection (Zostavax), intramuscular injection (Shingrix)
    ATC code
    Legal status
    Legal status
    • In general: ℞ (Prescription only)
    Identifiers
    ChemSpider
    • none
      (verify)

    Zoster vaccines includes a number of vaccines that have been shown to reduce the incidence of herpes zoster (also known as shingles). One type of 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] A recombinant version was approved in the United States in 2017.[3]

    Medical uses

    Zostavax

    A Cochrane review concluded that "herpes zoster vaccine is effective in preventing herpes zoster disease and this protection can last three years".[4] 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 percent in a study of 38,000 adults aged 60 and older who received the vaccine. The vaccine also reduced by 67 percent the number of cases of postherpetic neuralgia and reduced the severity and duration of pain and discomfort associated with shingles, by 61 percent.[5][6][7] 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:[8][9]

    • 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,[10] and those who do not recall having had chickenpox, since more than 99 percent of Americans ages 40 and older have had chickenpox.[11]

    Shingrix

    The Advisory Committee on Immunization Practices (ACIP) recommended 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.[12]

    The absolute decrease in risk of herpes zoster following immunization over three and a half years is 3.3% while the decrease in the risk of post herpetic neuralgia is 0.3%.[13]

    Side effects

    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.[14][15]

    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).[16]

    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.[14]

    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.[17] Mild to moderate pain at the injection site is common, and some may have redness or swelling.[17] Side effects include fatigue, muscle pain, headache, shivering, fever, and nausea.[17] Symptoms usually resolve in two to three days.[17]

    Composition

    The live Zostavax 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.[14] It is injected subcutaneously (under the skin) in the upper arm.[18] The live vaccine was developed using the MRC-5 line of fetal stem cells.[19] This has raised religious and ethical concerns for some potential users, since that cell line was derived from an aborted fetus.[20]

    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 adjuvant suspension. The antigen is a purified truncated form of the VZV gE expressed in Chinese Hamster Ovary cells. The AS01B adjuvant suspension is composed of 3-O-desacyl-4'- monophosphoryl lipid A (MPL) from Salmonella minnesota and a saponin molecule (QS-21) purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation consisting of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate-buffered saline solution.[21]

    Society and culture

    Cost effectiveness

    In Canada the cost of Shingrix is about 300 CAD for the two doses.[13]


    A 2007 study found that the live vaccine is likely to be cost-effective in the U.S., projecting an annual savings of $82 to $103 million in healthcare costs with cost-effectiveness ratios ranging from $16,229 to $27,609 per quality-adjusted life year gained.[22] In 2007, the live vaccine was officially recommended in the U.S. for healthy adults aged 60 and over.[23][24]

    Aproval

    European Union

    In 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.[25] In 2007, the EMEA updated the marketing authorisation for routine vaccination in individuals aged 50 and over.[26]

    United Kingdom

    From 2013 the UK National Health Service 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.[27] The original intention was for people aged between 70 and 79 to be vaccinated, 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.[28]

    United States

    Zostavax was developed by Merck & Co. and approved and licensed by the U.S. Food and Drug Administration (FDA) in May 2006,[5] In 2011, the FDA approved the live vaccine for use in individuals 50 to 59 years of age.[7][29] Shringrix is a zoster vaccine developed by GlaxoSmithKline that was approved in the United States by the FDA in October 2017.[30]

    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. PMC 4017882. PMID 18419402.
    3. ↑ "Zoster Vaccine Recombinant, Adjuvanted" (PDF). Retrieved 7 November 2017.
    4. ↑ Gagliardi, AM; Andriolo, BN; Torloni, MR; Soares, BG (3 March 2016). "Vaccines for preventing herpes zoster in older adults". Cochrane Database Syst Rev. 3: CD008858. doi:10.1002/14651858.CD008858.pub3. PMID 26937872.
    5. 1 2 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.
    6. ↑ "FDA Licenses New Vaccine to Reduce Older Americans' Risk of Shingles" (Press release). U.S. Food and Drug Administration (FDA). May 26, 2006. Retrieved October 31, 2009.
    7. 1 2 Zostavax Full Prescribing Information. Merck & Co. March 2011.
    8. ↑ "Patient Information (Text) about Zostavax-May 2006". U.S. Food and Drug Administration (FDA). May 2006. Archived from the original on June 19, 2009. Retrieved October 31, 2009.
    9. ↑ "Patient Information about Zostavax (Text) 12/2008". U.S. Food and Drug Administration (FDA). December 2008. Retrieved October 31, 2009.
    10. ↑ "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.
    11. ↑ Vaccines: VPD-VAC/Shingles/Shingles (Herpes zoster) Vaccination: What You Need to Know
    12. ↑ "ACIP: New Vaccine Recommendations for Shingles Prevention". MPR. October 25, 2017. Retrieved October 30, 2017.
    13. 1 2 "[114] Shingrix: A New Vaccine for Shingles | Therapeutics Initiative". Therapeutics Initiative. 11 October 2018. Retrieved 14 October 2018.
    14. 1 2 3 http://www.vaccines.mil/documents/shingles_qa.pdf
    15. ↑ Harris, Scott (January 18, 2011). "Never Too Late to Seek Protection Against 'Debilitating' Virus". WebMD. Retrieved 4 January 2014.
    16. ↑ Cunha, John P. "Zostavax Side Effects Center". RxList. Retrieved 4 January 2014.
    17. 1 2 3 4 "Shingrix shingles vaccination: What you should know". CDC. February 28, 2018. Retrieved April 29, 2018.
    18. ↑ "Zoster vaccine live". Medicinenet.com. Retrieved April 29, 2018.
    19. ↑ "Zostavax prescribing information" (PDF). FDA. Retrieved April 29, 2018.
    20. ↑ http://micro.magnet.fsu.edu/primer/techniques/fluorescence/gallery/cells/mrc5/mrc5cells.html
    21. ↑ "FDA Shingrix Briefing Document" (PDF). Food and Drug Administration (FDA). Retrieved October 28, 2017.
    22. ↑ 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.
    23. ↑ Harpaz R, Ortega-Sanchez IR, Seward JF (June 6, 2008). "Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP)". MMWR Recomm. Rep. 57 (RR–5): 1–30, quiz CE2–4. PMID 18528318. Archived from the original on November 17, 2009. Retrieved 2010-01-04.
    24. ↑ 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. Archived from the original on 23 December 2007.
    25. ↑ "Zostavax European Public Assessment Report" (PDF). European Medicines Agency (EMEA). July 2006. Retrieved March 27, 2011.
    26. ↑ "Zostavax-H-C-674-II-03 Scientific Discussion" (PDF). June 21, 2007. Retrieved March 27, 2011.
    27. ↑ "Shingles vaccination – Vaccinations – NHS Choices". Archived from the original on 2014-06-02. Retrieved 2014-05-31.
    28. ↑ "Who can have the shingles vaccine? – Vaccinations – NHS Choices". Archived from the original on 2014-04-10. Retrieved 2014-05-31.
    29. ↑ "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. Archived from the original on March 27, 2011. Retrieved March 27, 2011.
    30. ↑ "BBL approval" (PDF). FDA. October 20, 2017. Retrieved April 29, 2018.
    • Zostavax Product Page U.S. Food and Drug Administration (FDA)
    • Shingrix Product Page Food and Drug Administration (FDA)
    • Vaccine Information Statement U.S. Centers for Disease Control and Prevention (CDC)
    • Consumer Affairs Branch, CBER (28 March 2018). "Zostavax (Herpes Zoster Vaccine) Questions and Answers". Questions about Vaccines. FDA. Retrieved 28 March 2018.
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