FDA expands approval of Merck & Co.'s Zostavax vaccine

The FDA on Thursday expanded approval of Merck & Co.'s Zostavax to include patients aged 50 to 59. The herpes zoster vaccine is already approved for patients aged 60 years and older.

US regulators noted that the expanded approval was based on data from a study that randomised approximately 22,000 patients aged 50 to 59 to receive either Zostavax or placebo. Data showed that compared to placebo, Zostavax reduced the risk of shingles by approximately 70 percent.

Commenting on the approval, Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, noted that "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.

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