EMA finds no causal relationship on narcolepsy and use of GSK's Pandemrix

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has reviewed further data from Finland on the suspected link between narcolepsy in children and adolescents and Pandemrix, UK drug giant GlaxoSmithKline’s (LSE: GSK) H1N1 flu vaccine. 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 rates of reporting of narcolepsy. Additionally in Canada, where there has been substantial use of this type of vaccine, there has been no evidence of an increase in reports of narcolepsy. Therefore, at present definitive conclusions cannot be drawn and no changes to the recommendations for use of Pandemrix are proposed.

The World Health Organization, which is also reviewing the situation, recently concluded that further evaluation of the reported link to the rare sleeping disorder narcolepsy with use of Pandemrix is warranted. The WHO instigated a review earlier this month, after the National Institute for Health and Welfare (THL) of Finland issued a preliminary statement about investigations into the cases in Finland (The Pharma Letter February 10 and 3).