EMA Reviews Further Data on Narcolepsy

The CHMP has reviewed further data from Finland on the suspected link between narcolepsy in children and adolescents and Pandemrix, and concluded the data were still insufficient to establish a causal relationship between Pandemrix and narcolepsy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reviewed further data from Finland on the potential link between narcolepsy in children and adolescents and Pandemrix.

The Committee concluded that the new evidence added to the concern arising from case reports in Finland and Sweden, but that the data were still insufficient to establish a causal relationship between Pandemrix and narcolepsy. Further analyses and study results are awaited to clarify the observations in Finland.

In addition to the data from Finland, research is ongoing in Sweden where there has also been an unexpected number of narcolepsy reports following vaccination with Pandemrix. However, other non-Nordic countries have not seen similar increased