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Merck Zostavax data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Merck's shingles vaccine Zostavax (herpes zoster vaccine live (Oka/Merck)) reduced both total pain burden and postherpetic neuralgia by more than 60%, according to a 38,500-patient study published in the June 2 New England Journal of Medicine. The Phase III Shingles Prevention Study showed that the vaccine reduced total burden of pain and discomfort by 61.1% and postherpetic neuralgia by 66.5% (p<0.001). Overall shingles incidence was also significantly reduced, by 51.3%. Merck submitted a Zostavax BLA to FDA April 25 but has not yet been notified regarding a priority review designation (1Pharmaceutical Approvals Monthly May 2005, In Brief)...
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