May 29 2006
A new vaccine which reduces the risk of shingles (herpes zoster) for use in people 60 years of age and older has won approval from the U.S. Food and Drug Administration.
The vaccine, Zostavax, is designed to treat shingles which is caused by the reactivation of the virus that causes chickenpox and is a painful disease characterized by a blistering rash.
The varicella-zoster virus, the same virus that causes chickenpox, the varicella-zoster virus lies dormant following an attack of chickenpox, in certain nerve tissue and as people age, the virus sometimes reappears in the form of shingles.
Shingles is thought to affect 2 in every 10 people in their lifetime and manifests as clusters of blisters, which develop on one side of the body and can cause severe pain that may last for weeks, months or years after the virus reappears.
Jesse L. Goodman, MD, MPH, Director of FDA's Center for Biologics Evaluation and Research, says the vaccine will give health care providers an important tool that can help prevent an illness that affects many older Americans and often results in significant chronic pain.
Drug manufacturer Merck says Zostavax is a live virus vaccine which boosts immunity against varicella-zoster and involves a single injection in the upper arm.
Zostavax was trialed in approximately 38,000 individuals throughout the United States who were 60 years of age and older.
In the trial half received Zostavax and half received a placebo and in a three year follow up it was found that in individuals ages 60 - 69 it reduced the occurrence of the disease by 64%.
In those who developed the disease despite the vaccine the duration of pain following the onset of shingles was slightly reduced.
The most common side effects experienced in people who received Zostavax were redness, pain and tenderness, swelling at the site of injection, itching and headache.