FDA Denies Approval for GlaxoSmithKline (GSK) Bird Flu Vaccine
3/25/2013 8:01:18 AM
Just weeks after questions were raised about a GlaxoSmithKline flu vaccine and its links to narcolepsy, the FDA has issued a complete response letter for a newer vaccine that contains the same supercharged adjuvant, which is an agent that can stimulate the immune system and increase the response to a vaccine. The new vaccine is called Q-Pan H5N1 and was approved unanimously last November by an FDA advisory committee for combatting bird flu. Since then, however, there have been concerns about the adjuvant. There are no seasonal flu vaccines used in the US that contain adjuvants, and this includes an existing bird flu vaccine in the US emergency stockpile. But a recent study found that children in England who received the existing Pandemrix vaccine during the 2009-2010 swine flu pandemic had a 14-fold heightened risk of developing narcolepsy (back story). Earlier studies found similar associations.