Zostavax
| Vaccine description | |
|---|---|
| Target disease | Herpes zoster, postherpetic neuralgia, Ramsay Hunt syndrome type II, chickenpox |
| Type | Attenuated virus |
| Clinical data | |
| Pregnancy cat. | C (US) |
| Legal status | ℞ Prescription only |
| Routes | subcutaneous injection |
| Identifiers | |
| ATC code | J07BK02 |
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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%.[1][2] Local reactions at the injection site were generally mild.
Zostavax was approved and licensed by the U.S. Food and Drug Administration (FDA) in May 2006.[3][4][5] The FDA originally recommended it only for individuals 60 years of age or older who met the following requirements:[6][7]
- Has not had a life-threatening allergic reaction to gelatin, the antibiotic neomycin, or other component of the herpes zoster vaccine.
- 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.
- Does not have active, untreated tuberculosis.
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 Zostavax be given to all adults age 60 and over, including those who have had a previous episode of shingles,[8] and those who do not recall having had chickenpox, since more than 99% of Americans ages 40 and older have had chickenpox.[9]
On May 19, 2006, the European Medicines Agency (EMEA) issued a marketing authorisation for Zostavax to Sanofi Pasteur for routine vaccination in individuals aged 60 and over.[10] And in 2007, updated the marketing authorisation for routine vaccination in individuals aged 50 and over.[11]
On March 24, 2011, the FDA approved Zostavax for individuals 50 to 59 years of age.[5][12]
The duration of protection beyond 4 years after vaccination with Zostavax is unknown. The need for re-vaccination has not been defined.
References [edit]
- ^ Zostavax is, essentially, a larger-than-normal dose of Varivax, the chickenpox vaccine, as both shingles (prevented by Zostavax) and chickenpox (prevented by Varivax, even prevented by Zostavax as well) are caused by the same virus, Varicella Zoster Virus (VZV). 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.
- ^ Oxman MN, Levin MJ, 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. PMID 18419402.
- ^ 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.
- ^ "FDA Licenses New Vaccine to Reduce Older Americans' Risk of Shingles" (Press release). Food and Drug Administration. May 26, 2006. Retrieved October 31, 2009.
- ^ a b Zostavax Full Prescribing Information. Merck & Co. March 2011.
- ^ "Patient Information (Text) about Zostavax-May 2006". Food and Drug Administration. May 2006. Retrieved October 31, 2009.[dead link]
- ^ "Patient Information about Zostavax (Text) 12/2008". Food and Drug Administration. December 2008. Retrieved October 31, 2009.[dead link]
- ^ "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.
- ^ Vaccines: VPD-VAC/Shingles/Shingles (Herpes zoster) Vaccination: What You Need to Know
- ^ "Zostavax European Public Assessment Report". European Medicines Agency (EMEA). July 2006. Retrieved March 27, 2011.
- ^ "Zostavax-H-C-674-II-03 Scientific Discussion". June 21, 2007. Retrieved March 27, 2011.
- ^ "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.
External links [edit]
- Official website Merck & Co. product page
- Official website Zostavax web page
- Zostavax Product Page U.S. Food and Drug Administration (FDA)
- Vaccine Information Statement U.S. Centers for Disease Control and Prevention (CDC)
- Zostavax (Herpes Zoster Vaccine) Questions and Answers Food and Drug Administration
- Zostavax product information European Medicines Agency (EMEA)
- Zostavax Patient Information Merck & Co.
- Zostavax Prescribing Information Merck & Co.
- Zostavax Full Prescribing Information Merck & Co.
- "Zoster (Herpes Zoster)" Australian Immunisation Handbook 9th Edition April 2009
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