From Medscape Medical News > Alerts, Approvals and Safety Changes > FDA Approvals
FDA Approves Zoster Vaccine for Younger Adults
Susan Jeffrey
March 24, 2011 ? The US Food and Drug Administration (FDA) announced today approval for a vaccine to prevent herpes zoster, also known as shingles, in adults age 50 to 59 years.
The vaccine (Zostavax, Merck & Co., Inc.), a live attenuated virus vaccine, was already approved for prevention of zoster in adults 60 years of age and older in May 2006.
«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, MD, director of FDA’s Center for Biologics Evaluation and Research, in a news release.
Approval was based on a multicenter placebo-controlled trial conducted in the United States and 4 other countries among approximately 22,000 adults who were 50 to 59 years of age. Study participants were followed for at least 1 year for the development of zoster. Results showed that compared with placebo, the vaccine reduced the risk of developing zoster by approximately 70%.
The most common side effects observed were redness, pain, and swelling at the site of injection and headache.
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