Reuters: Regulatory News: EU drugs agency has "no new concerns" about GSK's flu shot

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EU drugs agency has "no new concerns" about GSK's flu shot Oct 19th 2012, 09:54 LONDON | Fri Oct 19, 2012 5:54am EDT LONDON Oct 19 (Reuters) - European drugs regulators said on Friday that evidence suggesting a link between GlaxoSmithKline's Pandemrix flu vaccine and a sleeping disorder called narcolepsy is "insufficient" and does not lead to any new concerns. Pandemrix was designed to protect against the H1N1 pandemic flu which spread around the world in 2009 and 2010. At least 30.8 million people in Europe were vaccinated with it during the pandemic. The European Medicines Agency (EMA) began a review of the vaccine's safety in 2010 after Finnish researchers presented evidence suggesting it might be linked to a rise in cases of narcolepsy, a rare condition which causes a person to fall asleep suddenly and unexpectedly. "After careful consideration, the (committee) concluded that the data presented by the Finnish researchers are preliminary and that the evidence presented so far is insufficient to allow conclusions to be drawn," EMA said in a statement.

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