The FDA has approved the use of Zostavax, a live attenuated virus vaccine, for
the prevention of shingles in individuals 50 to 59 years of age. Zostavax is
already approved for use in individuals 60 years of age and older.
In the United
States shingles affects approximately
200,000 healthy people between the ages of 50 and 59, per year. It is a disease
caused by the varicella-zoster virus, which is a virus in the herpes family and
the same virus that causes chickenpox. After an attack of chickenpox, the virus
lies dormant in certain nerves in the body. For reasons that are not fully
understood, the virus can reappear in the form of shingles, more commonly in
people with weakened immune systems and with aging.
"The likelihood of shingles increases with age. The
availability of Zostavax to a younger age group provides an additional
opportunity to prevent this often painful and debilitating disease" said
Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and
Research.
Shingles is characterized by a rash of blisters, which
generally develop in a band on one side of the body and can cause severe pain
that may last for weeks, and in some people, for months or years after the
episode.
Approval was based on a multicenter study conducted in the United States
and four other countries in approximately 22,000 people who were 50-59 years of
age. Half received Zostavax and half received a placebo. Study participants
were then monitored for at least one year to see if they developed shingles.
Compared with placebo, Zostavax reduced the risk of developing shingles by
approximately 70 percent.
The most common side effects observed in the study were
redness, pain and swelling at the site of injection, and headache.
Zostavax was originally approved on May 26, 2006, for the
prevention of shingles in individuals 60 years of age and older.
Zostavax is manufactured by Merck & Co. Inc., of Whitehouse Station, New
Jersey.