US FDA clears GlaxoSmithKline’s H5N1 flu vaccine

The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s (LSE: GSK) pandemic Influenza A (H5N1) for the immunization of adults 18 and older for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine.

The Q-Pan H5N1 influenza vaccine is composed of monovalent, inactivated, split A/H5N1 influenza virus antigen and GSK’s AS03adjuvant. In clinical studies, the adjuvanted formulation stimulated the required immune response while using a smaller amount of antigen as compared to a formulation without adjuvant.  This could translate to a greater number of doses available at the time of a pandemic.

“Supporting the US government’s capability to help protect Americans against pandemics ranks among GSK’s most important US public-health responsibilities,” said Bruce Innis, vice president of vaccines development at GSK. “H5N1-related illness has thus far been rare, but life-threatening when it has occurred. GSK scientists approached this clinical development project driven by the recognition that the resulting vaccine might be needed in the future to help protect millions of Americans against pandemic flu illness,” he explained.