FDA expands approval of shingles vaccine

March 25, 2011

FDA has approved an expanded age indication for Zoster Vaccine Live, (Zostavax, Merck) for the prevention of herpes zoster, commonly known as shingles, in adults ages 50 years and older.

FDA has approved an expanded age indication for Zoster Vaccine Live, (Zostavax, Merck) for the prevention of herpes zoster, commonly known as shingles, in adults ages 50 years and older. Zostavax was first approved in May 2006 for the prevention of shingles in individuals of 60 years and older.

In a multicenter study of approximately 22,000 people conducted in the United States and 4 other countries, Zostavax significantly reduced the risk of developing shingles by nearly 70% in adults ages 50 to 59, compared with placebo. The most common side effects observed in the study were redness, pain, and swelling at the site of injection, and headache.

Zostavax is the only shingles vaccine licensed for use in the United States.

According to the US Centers for Disease Control and Prevention, approximately 1 in 3 people will experience shingles in their lifetime and nearly 1 million cases of shingles occur each year. The incidence and severity of shingles increase with age. Once a person has had chickenpox, the varicella-zoster virus stays inside the body and can resurface later as shingles.

Zostavax is not indicated for the treatment of shingles or postherpetic neuralgia, or for the prevention of chickenpox. Zostavax is contraindicated for individuals who are allergic to any of its ingredients, including gelatin or neomycin; have a weakened immune system; or take high doses of steroids. It is also contraindicated for individuals who are pregnant or plan to become pregnant. Vaccination with Zostavax may not result in protection of all vaccine recipients.

Zostavax is currently on back order. Merck will continue to release doses of Zostavax as supply becomes available, but as inventory is building, back orders will still occur. Timely information about the shipping schedule for ZOSTAVAX can be found at MerckVaccines.com.