Complete Response Letter from FDA for Q-Pan H5N1 influenza vaccine

GSK has received a Complete Response Letter from the FDA for its pandemic influenza A vaccine, called Q-Pan H5N1. Q-PAN H5N1 is intended for the prevention of Infuenza in adults who are at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine.

In November 2012, the FDA�s Vaccines and Related Biological Products Advisory Committee voted unanimously 14-0 that the safety and immunogenicity data of the H5N1 adjuvanted influenza vaccine supported its approval for bird flu. However concerns have been expressed about a similar GSK vaccine called Pandemrix which uses the same adjuvant, ASO3, which boosts the response to the treatment. The European Medicines Agency began a review to investigate a possible link between Pandemrix and narcolepsy, following an increased number of cases among children and adolescents in Finland and Sweden. A recent study found that children in England who received Pandemrix vaccine during the 2009-2010 swine flu pandemic had a 14-fold heightened risk of developing narcolepsy.