Pandemrix, the H1N1 vaccine produced by GlaxoSmithKline, has been linked to an increased incidence of narcolepsy in children that received the vaccine. Narcolepsy is a chronic sleep disorder with symptoms including, daytime sleepiness, hallucinations, and cataplexy (sudden loss of muscle tone and inability to move triggered by strong emotion).
The vaccine, administered in 2009-2010, has been linked to more than eight hundred cases of narcolepsy in children. Studies in Finland and Britain found that children are 13-14 times more likely to suffer from narcolepsy after receiving the vaccine.
While studies regarding the cause of this increase are ongoing, it is likely that the vaccine’s adjuvant, AS03, a squalene-based adjuvant, plays a role. Some researchers believe that the increased effectiveness of AS03 in boosting an immune response could have increased an adverse immune response as well.
This raises concerns in the U.S. and around the world as this adjuvant is a component of other vaccines being administered and being considered outside of Europe. For instance, the FDA is considering another vaccine from GlaxoSmithKline that contains AS03 to be used in the event of an outbreak of the bird flu. In November 2012, an FDA advisory panel recommended approval of this H5N1 bird flu vaccine.
However, since then, new data suggest the link between the adjuvant and narcolepsy is greater than it initially appeared. Because of this new information, at least one member of the panel would like the FDA to reconvene the panel for further discussion. Meanwhile, GlaxoSmithKline is conducting a study of Arepanrix, an H1N1 vaccine. Arepanrix is another vaccine containing AS03 that was administered to approximately two million children in Canada.
Due to the potential risk of a serious vaccine injury like narcolepsy, and the ongoing research, the FDA should consider reconvening the panel for more in-depth inquiry and a discussion of the implications and risk/benefit analysis.
If you think your child may have been injured by Pandemrix or any other vaccine, please contact Kraus Law Group, LLC , in Chicago, Illinois, to learn more about vaccine injury compensation.