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Biosecurity News in Brief
HHS Extends VaxGen’s Deadline to Resolve Clinical Hold on Anthrax VaccineBy Allison Chamberlain, November 17, 2006 Updating anthrax vaccine news from last week’s Biosecurity Briefing report, VaxGen announced in a November 16, 2006, press release[1] that the U.S. Department of Health and Human Services (HHS) has extended by more than a month the deadline for VaxGen to resolve the clinical hold placed on its anthrax vaccine trials by the Food and Drug Administration (FDA).[1] The clinical hold, which was issued by the FDA on November 3, 2006, was placed on VaxGen following the FDA’s concerns about the vaccine’s stability.[1] Under HHS’ accompanying cure notice conditions,[2] VaxGen had until November 13—10 days after the receipt of the clinical hold cure notice—to resolve the issues contributing to the vaccine’s instability.[2] As described in the November 16 press release,[1] the new December 18, 2006, deadline for resolution was set by HHS in a November 15 letter to the company.[1] According to the press release, the HHS letter also informed VaxGen that plans are being made to “issue a contract modification to re-establish the due date for VaxGen to initiate its next clinical trial.”[1] In order to further discuss the FDA’s concerns about the stability of its anthrax vaccine, VaxGen has “requested to meet with the FDA no later than the middle of December.”[1]
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