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FDA Panel Gives Nod to Bird Flu Vaccine

An FDA advisory panel has voted in favor of a vaccine against the highly pathogenic H5N1 avian flu that would be stockpiled and used in case of pandemic.

By twin votes of 14-0, the panel agreed that the immunogenicity and the safety of the vaccine, made in Quebec by GlaxoSmithKline, were enough to meet licensing standards under accelerated approval regulations.

Those rules -- set out in 2007 -- allow rapid approval of a vaccine on the basis of markers that are likely to predict clinical benefit. In the case of this vaccine, dubbed Q-Pan H5N1, the surrogate marker was antibody response measured by a hemagglutination-inhibition (HI) assay.
 
 

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