Pharmaceutical Business review

FDA expands Merck shingles vaccine approval

Zostavax, which is manufactured by Merck, was originally approved by the FDA for the prevention of shingles in individuals 60 years of age and older.

The approval was based on a multicentre study which enrolled approximately 22,000 people of 50-59 years of age, who were randomised to receive either Zostavax or placebo.

The participants were monitored for one year, and the study results revealed that Zostavax reduced the risk of developing shingles by approximately 70%, compared to placebo.

FDA Center for Biologics Evaluation and Research director Karen Midthun said the availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease.