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Lessons from FDA panels on adjuvanted vaccines from GSK, Dynavax
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A tale of two adjuvants
By Erin McCallister& Michael J. Haas
Senior Writers
Published on
Monday, December 3, 2012
The different results from FDA's panel reviews of Q-Pan H5N1
influenza vaccine from GlaxoSmithKline
plc and Heplisav HBV vaccine from Dynavax
Technologies Corp. provide three clear messages to companies developing
adjuvanted vaccines: the larger the safety database, the better; no two
adjuvants are alike; and both of these factors must be evaluated in the context
of the indication.
On Nov. 14, FDA's Vaccines and
Related Biological Products Advisory Committee voted unanimously to support
accelerated approval of GSK's Q-Pan H5N1 vaccine, with much of the discussion
focused on the confirmatory trial.
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