The suspected linkbetween narcolepsy and Pandemrix H1N1 vaccine is insufficiently supported by evidence, according to he Committee for Medicinal Products for Human Use (CHMP).
The conclusion is based on a review of the suspected link between narcolepsy in children and adolescents and Pandemrix (influenzavaccine (H1N1)), fromGlaxoSmithKline Biologicals S.A.
The results were presented at the CHMP meeting on 14-17 February 2011.
The Committee concluded that the newevidence added to the concern arising from case reports in Finland andSweden, but that the data were still insufficient to establish a causalrelationship between Pandemrix and narcolepsy.
Further analyses andstudy results are awaited to clarify the observations in Finland.