FDA Approves Merck's Shingles Vaccine
Posted on: Friday, 26 May 2006, 12:00 CDT
The Food and Drug Administration Friday approved Merck's shingles vaccine Zostavax for people 60 years of age and older.
This vaccine gives health care providers an important tool that can help prevent an illness that affects many older Americans and often results in significant chronic pain, said Jesse L. Goodman, director of the FDA's Center for Biologics Evaluation and Research.
Merck has agreed to conduct a phase 4 study of the vaccine to provide additional safety information, the FDA said.
Zostavax, which protects against re-emergence of the chickenpox virus herpes zoster, is given as a single injection.
In a study involving 38,000 people who were 60 or older, the vaccine reduced shingles outbreaks by 50 percent compared to placebo. In people who were age 60-69, Zostavax reduced shingles occurrence by 64 percent.
Source: United Press International
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