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.