What is ZOSTAVAX?
Zostavax is a vaccine available as a powder and solvent to be reconstituted in a solution for injection. The active ingredient is the attenuated (weakened) virus of varicella-zoster.
What is ZOSTAVAX used for?
Zostavax is used to vaccinate people from the age of 50 to prevent shingles (also known as zoster or shingles) and prolonged nerve pain following 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?
Shingles, or shingles, is a disease caused by the varicella-zoster virus, the same virus that causes chickenpox. The shingles develop in people who have contracted chickenpox previously, generally as children. After chickenpox, the virus remains in the body, in the nervous system, in a state of "inactivity".
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 eruption with blisters typically located in a delimited area of the body. The eruption usually lasts a few weeks and can be followed by a long and persistent pain (post herpetic neuralgia) in the area affected by the eruption.
The risk of developing shingles seems to be connected with the lowering of immune defenses (protection) against varicella-zoster virus. Zostavax is a vaccine that has been shown to increase the level of specific immunity, protecting against shingles and the pain associated with it.
What studies have been carried out on ZOSTAVAX?
The main study on Zostavax compared the placebo vaccine (a fake vaccine) on about 39, 000 patients aged 59 to 99 years. The study was conducted in double blind, ie neither the doctor nor the patient was aware of the treatment given to the patient. Patients were followed for 2 to 4 and a half years after vaccination. The main efficacy criterion was based on the number of people who developed shingles and post-herpetic pains.
Two further studies examined Zostavax on more than 1, 000 patients aged 50 and over, 389 of whom were aged between 50 and 59 years. The studies aimed to verify the ability of the vaccine to stimulate the production of antibodies against 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 shingles. After vaccination with Zostavax, they developed less fire than people with placebo. 315 of the 19 254 patients who were injected with Zostavax developed shingles during the study, compared to 642 out of 19 247 who received a placebo. Zostavax also proved more effective than placebo in preventing post herpetic neuralgia: 27 patients treated with Zostavax suffered from post-herpetic neuralgia, compared to 80 in the placebo group.
The two further studies showed that, four weeks after vaccination, patients vaccinated with Zostavax had an antibody level against varicella-zoster virus in the blood two to three times higher. The effect was observed both in patients aged 50 to 59 years and in those of an older age.
What are the risks associated with ZOSTAVAX?
The most common side effects associated with Zostavax seen in the studies (more than 1 in 10 patients) are reactions at the point of injection (redness, pain, swelling, itching, feeling of heat and irritation). For the full list of all side effects reported with Zostavax, see the Package Leaflet.
Zostavax should 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 with an effect on the immune system. It must also not be used in patients with active untreated tuberculosis or pregnant women. For the complete list of limitations, 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 marketing authorization.
More information on ZOSTAVAX
On May 19, 2006, the European Commission issued an authorization for the marketing of Zostavax to Sanofi Pasteur MSD, SNC, valid throughout the European Union. After five years, the marketing authorization was renewed for a further five years.
For more information on Zostavax therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 02/2011.
