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Senior Health & Medicine
Zostavax Shingles Vaccine
Approved for Senior Citizens
FDA says it is for those
age 60 and older who are most at risk
May 26, 2006 - The Food
and Drug Administration (FDA) yesterday licensed Zostavax, a new vaccine
to reduce the risk of shingles (herpes zoster) for use in people 60
years of age and older.
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FDA Panel Says Shingles Vaccine Zostavax Okay for
Senior Citizens
Data does not support use for Baby Boomers
Dec. 18, 2005 A panel of the U.S. Food and Drug
Administration has determined the vaccine Zostavax, made by Merck & Co.,
is safe for senior citizens 60 and over to use for preventing shingles.
The extremely painful condition is estimated to strike about half of all
seniors by the time they reach age 85.
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Shingles is a disease
caused by the varicella-zoster virus, the same virus that causes
chickenpox. After an attack of chickenpox, the virus lies dormant in
certain nerve tissue.
As people age, it is
possible for the virus to reappear in the form of shingles, which is
estimated to affect 2 in every 10 people in their lifetime. Shingles is
characterized by 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.
"This vaccine gives
health care providers an important tool that can help prevent an illness
that affects many older Americans and often results in significant
chronic pain," said Jesse L. Goodman, MD, MPH, Director of FDA's Center
for Biologics Evaluation and Research.
Zostavax, a live virus
vaccine, was shown to boost immunity against varicella-zoster virus.
This is thought to be the mechanism by which the vaccine protects
against zoster and its complications. The vaccine is given as a single
injection under the skin, preferably in the upper arm.
Zostavax was studied in
approximately 38,000 individuals throughout the United States who were
60 years of age and older. Of these 38,000 people, half received
Zostavax and half received a placebo. All study participants were then
followed for an average of three years to see if they developed shingles
and, if they did, how long the pain lasted.
At the conclusion of the
study, researchers found that, overall, in those ages 60 and above the
vaccine reduced the occurrence of shingles by about 50%. For individuals
ages 60-69 it reduced occurrence by 64%.
In addition to
preventing approximately half of the cases, the duration of pain
following the onset of shingles was slightly reduced in people who
developed the diseasedespite being vaccinated with Zostavax.
The most common side
effects in people who received Zostavax were redness, pain and
tenderness, swelling at the site of injection, itching and headache. The
percent of significant adverse events observed in the study were not
different between persons who received the vaccine versus placebo.
As part of the
development program, a smaller study was conducted to look more closely
at safety. In this smaller study, serious adverse events for all age
groups were noted more frequently in those who received Zostavax (1.9%)
than those who received placebo (1.3%).
Although FDA has
concluded that the available data do not establish that these events are
related to the vaccine, the manufacturer will perform a Phase 4 (postmarket)
study to provide additional safety information.
Zostavax is manufactured
by Merck & Co., Inc., of Whitehouse Station, New Jersey.
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