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.