6:09 PM
 | 
Nov 12, 2012
 |  BC Extra  |  Company News

Reviewers: data support accelerated approval for adjuvanted flu vaccine

FDA reviewers said immunogenicity and safety data from two Phase III trials fulfill immunogenicity criteria to support accelerated approval of Q-Pan H5N1 adjuvanted vaccine from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). In the Q-Pan-H5N1-001 and Q-Pan-H5N1-002 trials, the injectable adjuvanted influenza vaccine met the primary immunogenicity endpoints based on a surrogate marker -- vaccine induced hemagglutination-inhibition (HAI) -- that is "reasonably...

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