Sanofi's H5N1 vacc gets tentative US approval

5 March 2007

Leading French drugmaker Sanofi-Aventis' vaccine for the pandemic strain of avian flu has received the backing of a US Food and Drug Administration committee. The expert panel recommended that the FDA approve the agent, despite the fact that it stimulated immunity in less that half of test subjects, short of the agency's 70% efficacy threshold. The FDA noted that the vaccine against the H5N1 strain of avian influenza is only an interim measure but, if approved, Sanofi's product will be the first one cleared in the USA, ahead of GlaxoSmithKline and Novartis who are developing similar products. The firm said that it does not plan to market the vaccine but would instead manufacture it for a national stockpile so that it could be given to health care professionals and other first-responders in the event of an epidemic.

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Chairman, Sanofi Aventis UK



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