FDA approves Q-Pan H5N1 vaccine for Influenza-Glaxo Smith Kline

The FDA has approved Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (also referred to as Q-Pan H5N1 influenza vaccine), from Glaxo Smith Kline, for the immunisation of adults 18 and older for the prevention of disease caused by the Influenza A virus H5N1 subtype contained in the vaccine. 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.

Licensure of the Q-pan H5N1 influenza vaccine is supported by data generated in two pivotal clinical studies showing that the vaccine was immunogenic and generally well-tolerated. The efficacy of GSK�s seasonal influenza vaccine FluLaval Quadrivalent in the prevention of influenza disease was also submitted as supportive information. In clinical trials, the most common solicited local reactions and general adverse events were injection site pain and swelling, muscle aches, headache, fatigue, joint pain, shivering and sweating. GSK�s Influenza A (H5N1) Virus Monovalent Vaccine has also received marketing authorisation in Europe and Canada under the brand names Pumarix and Arepanrix H5N1 respectively.