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, a live attenuated virus vaccine, was already approved for prevention of zoster in adults 60 years of age and older in May 2006.
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.