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FDA Approves Expanded Use of Shingles Vaccine

FDA Approves Expanded Use of Shingles Vaccine
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The U.S. Food and Drug Administration (FDA) has now approved use of the varicella-zoster vaccine, Zostavax, among patients ages 50 to 59 for the prevention of herpes zoster, more commonly known as shingles. Until now, use of the vaccine had only been sanctioned for use in people aged 60 or older.

Shingles is caused by the varicella-zoster virus, which is the same virus that causes chickenpox. Any person who has had chickenpox can develop shingles. The illness starts with either burning or tingling pain, or numbness or itch that is localized to one area on one side of the body. Within a week, a painful, blistery rash emerges. The pain associated with shingles may be mild or intense. In severe cases, the pain can continue for months, or even years.

Shingles most commonly occurs among older people having weakened immune systems but can strike at any age. The FDA first approved the shingles vaccine in 2006 for use in people 60 and over, after clinical data indicated that use of the vaccine the reduced the risk of developing shingles by 50 percent.

The approval for the use in the expanded age group was based on a study involving 22,000 people in five countries, including the United States. Participants between the ages of 50 and 59 were randomly selected to receive with the vaccine or a placebo. The participants were then followed for one year. Findings of the study indicated the risk for shingles among the vaccine group was 70 percent lower than among the placebo group. Adverse affects of the vaccine observed during the study included injection site redness, pain, swelling, and headache.

In a statement, the FDA said that among the newly approved 50 to 59 age group, about 200,000 people contract shingles each year. According to Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, “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.”

The Zostavax shingles vaccine is manufactured by Merck & Co Incorporated, based in Whitehouse Station, N.J. Zostavax is the only vaccine approved in the U.S. for shingles.

According to the Centers for Disease Control and Prevention in Atlanta, Georgia, nearly one in three Americans will develop shingles in their lifetime. It is estimated that about one million people in the U.S. develop the disease each year.

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