LONDON Oct 19 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
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
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.