Q-Pan H5N1 adjuvanted regulatory update

FDA's Vaccines and Related Biological Products Advisory Committee voted 14-0 that safety and immunogenicity data support accelerated approval of Q-Pan H5N1 adjuvanted vaccine from GlaxoSmithKline to prevent disease in adults who are at an increased risk of exposure to the influenza A virus subtype H5N1. The panel was divided on the non-voting topic of the options by which GSK can confirm Q-Pan H5N1's clinical benefit if FDA grants accelerated approval. At least 6 panel members said an effectiveness study of a seasonal, unadjuvanted influenza vaccine manufactured by the same process as Q-Pan H5N1 was more feasible, primarily because of potential difficulties in gathering sponsor-specific effectiveness data during a pandemic. At least 5 panel members favored an effectiveness study of Q-Pan H5N1 conducted during an H5N1 influenza virus pandemic, arguing that the challenges of conducting an effectiveness study during a pandemic are not insurmountable.

At the meeting, Bruce Innis, GSK's VP of vaccine discovery and development, said the pharma intends to pursue the first option. Innis said data from the Q-QIV-006 efficacy study of FluLaval - the pharma's seasonal, unadjuvanted H1N1 vaccine that uses the same manufacturing process as Q-Pan H5N1 - could be used to confirm the clinical benefit of Q-Pan H5N1. Innis added that GSK would collaborate with FDA and other U.S. government agencies to collect efficacy data for the vaccine during an H5N1 pandemic. ...