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www.fdanews.com/articles/63507-cdc-panel-votes-to-recommend-merck-s-shingles-vaccine

CDC PANEL VOTES TO RECOMMEND MERCK'S SHINGLES VACCINE

October 26, 2006

Merck has announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices voted unanimously to recommend that adults 60 and older be vaccinated with Zostavax (zoster vaccine live) to help prevent shingles.

The FDA approved Zostavax in May for the prevention of shingles in adults 60 and older. Zostavax is not a treatment for shingles or postherpetic neuralgia (long-term nerve pain that can be a complication of shingles). The vaccine is given by a single-dose by injection.

The committee also considered additional recommendations pertaining to specific uses of the vaccine. The recommendations are under review by the director of the CDC and HHS and will become official when published in the CDC's Morbidity and Mortality Weekly Report, according to Merck.

The efficacy and safety of a single dose of Zostavax was evaluated in the Shingles Prevention Study in 38,546 men and women 60 and older who had no previous history of shingles. This randomized, double-blind, placebo-controlled study was a Department of Veterans Affairs study conducted in collaboration with the National Institute of Allergy and Infectious Diseases and Merck at 22 U.S. research sites. Zostavax significantly reduced the risk of developing shingles compared with placebo by 51 in the study. Efficacy of Zostavax for the prevention of shingles was highest for those 60 to 69 years of age and declined with increasing age.

Merck makes Zostavax, as well as its other adult vaccines, available free of charge through a U.S. patient assistance program for low-income individuals for whom the vaccines are medically appropriate. The program began in September.