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.
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.
