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Zostavax earns expanded approval
The Food and Drug Administration (FDA) has approved the use of Zostavax (Merck), a live attenuated Varicella zoster virus vaccine, for the prevention of shingles in people ages 50 to 59 years old. The drug previously was approved for use in people ages 60 and older.
Washington - The Food and Drug Administration (FDA) has approved the use of Zostavax (Merck), a live attenuated Varicella zoster virus vaccine, for the prevention of shingles in people ages 50 to 59 years old. The drug previously was approved for use in people ages 60 and older.
Approval was based on a multicenter study conducted in the United States and four other countries in approximately 22,000 patients ages 50 to 59, PRNewswire reports. Half received Zostavax and half received placebo. Participants were monitored for at least one year to determine if they developed shingles. Zostavax reduced the risk of developing shingles by about 70 percent, when compared with placebo.
Commonly reported side effects of the vaccine included headache and injection-site redness, pain and swelling.
PRNewswire quotes Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research, as saying, "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."
