European drugs regulators say that evidence suggesting a link between the Pandemrix flu vaccine and narcolepsy is "insufficient".
Pandemrix is a vaccine developed by drugs developer GlaxoSmithKline, and was designed to protect the public against the H1N1 flu pandemic between 2009 and 2010. Over 30 million people in Europe were vaccinated during this period, but concerns were raised after Finnish research suggested that it may be linked to an increase in cases of narcolepsy, a rare condition which causes a person to fall asleep suddenly and unexpectedly.
The Finish National Institute of Health and Welfare (THL) investigated whether differences in immunological response -- which triggers narcolepsy -- may have been caused by different pandemic influenza vaccines.
The European Medicines Agency's Committee on Human Medicinal Products (CHMP) began reviewing the vaccine's safety in 2010, and released the following statement on Friday:
"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."
Pandemrix is currently not available in the EU.
Image credit: Andres Rueda