What is ZOSTAVAX?
Zostavax is a vaccine available as a powder and solvent to be made up into a solution for injection. The active substance is the attenuated (weakened) varicella-zoster virus.
What is ZOSTAVAX used for?
Zostavax is used to vaccinate people from 50 years of age to prevent herpes zoster (also known as St. Anthony's zoster) and prolonged nerve pain that follows the disease (post-herpetic neuralgia).
The vaccine can only be obtained with a prescription.
How is ZOSTAVAX used?
Zostavax is injected in a single dose under the skin, preferably around the shoulder.
How does ZOSTAVAX work?
Herpes zoster, or Saint Anthony's fire, is a disease caused by the varicella-zoster virus, the same virus that causes chickenpox. St. Anthony's Fire develops in people who have contracted chickenpox previously, usually as children. After chickenpox, the virus remains in the body, in the nervous system, in a "dormant" (inactive) state.
Sometimes, after many years and for reasons that are not yet very clear, the virus becomes active again and the patient develops St. Anthony's fire, a painful, blistering rash typically localized in a limited area of the body. The rash usually lasts a few weeks and may be followed by long and persistent pain (post herpetic neuralgia) in the area affected by the rash.
The risk of developing St. Anthony's fire appears to be connected with the lowering of the immune defenses (protection) against the varicella-zoster virus. Zostavax is a vaccine that has been shown to increase the level of "specific immunity, protecting against St. Anthony's fire" and the pain associated with it.
How has ZOSTAVAX been studied?
The main study of Zostavax compared the vaccine with placebo (a fake vaccine) in around 39,000 patients aged 59 to 99 years. The study was conducted in a double-blind manner, meaning neither the doctor nor the patient was aware of the treatment administered to the patient. Patients were followed up for 2 to 4 1/2 years after vaccination. The main criterion of effectiveness was based on the number of people who developed St. Anthony's fire and post-herpetic pains.
Two additional studies looked at Zostavax in more than 1,000 patients aged 50 and over, 389 of whom aged between 50 and 59. The studies aimed to test the vaccine's ability to stimulate the production of antibodies to the varicella zoster virus in the blood four weeks after the injection.
What benefit has ZOSTAVAX shown during the studies?
Zostavax was more effective than placebo in preventing San Antonio fire. Fewer people developed San Antonio fire after vaccination with Zostavax than with placebo. 315 of the 19 254 patients who were injected with Zostavax developed St. Anthony's focus during the study, compared with 642 of the 19 247 who were given a placebo. Zostavax was also more effective than placebo in preventing the Post-herpetic neuralgia: 27 patients treated with Zostavax suffered from post-herpetic neuralgia, compared with 80 in the placebo group.
The two further studies showed that, four weeks after vaccination, patients vaccinated with Zostavax had two to three times higher levels of antibodies to varicella-zoster virus in their blood. The effect was observed both in patients aged 50 to 59 years and in those older.
What are the risks associated with ZOSTAVAX?
The side effects associated with Zostavax seen most frequently in studies (in more than 1 in 10 patients) are reactions at the injection site (redness, pain, swelling, itching, warmth and irritation). full details of the side effects reported with Zostavax, see the package leaflet.
Zostavax must not be used in patients who are hypersensitive (allergic) to any of the components of the vaccine, including neomycin (an antibiotic). The vaccine should not be given to people with immune system problems, either in cases of diseases such as leukemia, lymphoma, acquired immune deficiency syndrome (AIDS) or because they are taking drugs that affect the immune system. It should also not be used in patients with untreated active tuberculosis or in pregnant women. For the full list of restrictions, see the Package Leaflet.
Why has ZOSTAVAX been approved?
The CHMP decided that Zostavax's benefits are greater than its risks and recommended that it be given a "marketing authorization" for the medicine.
More information about ZOSTAVAX
On 19 May 2006, the European Commission granted Sanofi Pasteur MSD, SNC, a "marketing authorization" for Zostavax, valid throughout the European Union. After five years, the "marketing authorization" was renewed for a further five years.
For more information about Zostavax therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. This summary was last updated 02/2011.
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