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FDA Warns VaxGen On Anthrax Vaccine

by Medindia Content Team on April 7, 2006 at 8:14 PM
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FDA Warns VaxGen On Anthrax Vaccine

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The Food and Drug Administration has warned the manufacturers of a new vaccine for anthrax for making false claims about the purity and effectiveness of the vaccine. VaxGen Inc was accused of inflating the claims based on a few studies, the data for which is not enough for issuing such statements.

The FDA took umbrage to a promotional handed out by the company in October, which claimed that the vaccine could be made "at nearly 100% purity." The promotional also claimed that the vaccine gives a longer immunity as s compared to some older vaccines.
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The FDA declared that such claims could not be made on the basis of only a handful of studies. The regulator also threatened legal action against the company unless it stops "disseminate truthful, non-misleading, and complete information" about the vaccine. Paul Laland, a VaxGen spokesman, said, "Based on our internal assessment and research of industry standards, we did not believe this was material information. We'll review it internally, and we're going to respond, and if needed we'll put a plan together. If there is something that's incorrect, then we will take corrective action." The company has been struggling to make 75 million doses of anthrax vaccine under federal contracts. These doses are believed to be enough to immunize 25 million people.
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