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FDA advisers recommend Merck's shingles vaccine for adults over 60, but not for ages 50 through 59
By E. Janene Geiss
Philadelphia, Dec. 15 - Merck & Co., Inc. announced Thursday that the U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee agreed that the extensive data from clinical trials in more than 40,000 people support the efficacy and safety of Zostavax, the company's investigational vaccine to prevent shingles in adults aged 60 and over.
The committee did not agree that the data presented were sufficient to support the efficacy and safety of Zostavax in adults aged 50 to 59 as the company had proposed, officials said in a company news release.
The committee also suggested areas for additional analysis. Merck said it plans to work with the FDA on these analyses, as well as the design of Merck's already planned post-licensure studies.
The FDA is not bound by the committee's recommendation, but takes its advice into consideration when reviewing investigational vaccines, officials said.
"Shingles can be a very painful disease that can lead to serious and long-lasting complications," Peter S. Kim, president of Merck Research Laboratories, said in the release. "We are pleased with today's outcome and look forward to working with the FDA as it continues its review of our application for this vaccine."
The company said it filed a Biologics License Application with the FDA on April 25 for Zostavax to reduce the risk of shingles, to reduce the risk of post-herpetic neuralgia, the persistent, often debilitating long-term nerve pain that is the most common complication of shingles and to reduce the total burden of pain and discomfort caused by shingles.
In addition to the U.S. regulatory application, Merck said it has filed regulatory applications for the vaccine in several other markets, including the European Union, Canada and Australia.
Merck is a Whitehouse Station, N.J., research-driven pharmaceutical company.
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