EMA: 'Insufficient' link between narcolepsy and GSK flu vaccine

European drug regulators deemed a connection between GlaxoSmithKline's ($GSK) Pandemrix flu vaccine and the sleeping disorder narcolepsy "insufficient," Reuters reports.

Finnish researchers presented evidence suggesting such a link after Pandemrix was designed and used to protect against the H1N1 pandemic flu, which spread around the world in 2009 and 2010. Pandemrix was used extensively during the outbreak, with at least 30.8 million people vaccinated in Europe.

The European Medicines Agency began a review of the vaccine's safety in 2010. On Friday, the agency announced that evidence presented so far does not lead to any new concerns regarding the safety of the vaccine.

"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, and does not lead to any new concerns regarding Pandemrix or other vaccines, including other influenza vaccines."

In 2011, the EMA's Committee for Medicinal Products for Human Use concluded that Pandemrix should only be used in people under the age of 20 if the recommended annual seasonal trivalent flu vaccine is not available and if immunization against H1N1 is considered necessary.

- see the EMA's statement
- get more from Reuters

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