The FDA extended the indication for live-attenuated varicella-zoster virus vaccine to include adults aged 50-to-59 years, a population in which shingles affects approximately 200,000 each year.
Zoster vaccine live (Zostavax, Merck) is already approved in the United States to prevent shingles — a disease characterized painful blisters that can last for months or years — in adults aged 60 years and older.
“The likelihood of shingles increases with age,” director of the FDA’s Center for Biologics Evaluation and Research, Karen Midthun, MD, said in a press release. “The availability of [zoster vaccine live] to a younger age group provides additional opportunity to prevent this often painful and debilitating disease.”
The approval comes after results of a multicenter study that involved 22,000 adults aged 50 to 59 years showed that the vaccine reduced the risk for developing shingles by approximately 70%. The most common adverse events included redness, pain and swelling at the injection site and headache.
Varicella-zoster is the same virus that causes chickenpox. Once an individual contracts the disease it lies dormant in the body and can reappear in the form of shingles later in life, most commonly in aging individuals with weakened immune systems.