Update on Pandemrix™ and interim Finnish report on narcolepsy

GSK is aware of today’s interim report by the Finnish National narcolepsy committee ^[1] on their investigation into reported cases of narcolepsy in Finland. This investigation is independent of a broader ongoing European Medicines Agency (EMA) investigation initiated in 2010. GSK is reviewing the report and believes it would be premature to draw any conclusions on a potential association between Pandemrix and narcolepsy until this European investigation has been completed.

Patient safety is of paramount importance to GSK and we have been working closely with the EMA and other national regulatory organisations to better understand the situation since reports of narcolepsy after vaccination with Pandemrix were first received. The company recognises the value of ongoing independent research to add further information.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed all of the available data on the suspected link between narcolepsy and Pandemrix in September 2010 and stated at that time that the benefit risk balance for Pandemrix remained positive. Since then GSK has continued to provide EMA with information on narcolepsy cases being reported to the company and to date there has been no change in EMA’s position.

Over 31 million doses of Pandemrix have been administered worldwide in 47 countries. A total of 162 cases of narcolepsy in people vaccinated with Pandemrix have been reported to GSK as of 31 January 2011; with 70% of these cases of narcolepsy originating from Finland and Sweden.

GSK has been working with EMA to continually evaluate reports of narcolepsy since the first reports of narcolepsy were received. As part of the European investigation on a potential association between Pandemrix and narcolepsy, GSK has submitted draft epidemiological study protocols to EMA for consideration. Based on the outcomes of their evaluation, GSK will then agree with EMA upon the appropriate next steps.

Narcolepsy is a chronic sleep disorder characterised by overwhelming daytime drowsiness and sudden sleep onset. The precise cause of narcolepsy is unknown, but there is growing evidence for either a genetic or environmental basis to the condition. Investigations into such diseases require time to collect the comprehensive data needed. This research is expected to go on for several months with new epidemiological studies being carried out to help reach firm conclusions.

Global experience with previous large scale immunisation programmes has shown that a certain number of suspected adverse events will be reported. These events may be the result of underlying conditions, or new conditions that occur in temporal association with the vaccination, and some events may be related to the vaccine.

^[1] A group of Finnish experts set up by the National Institute for Health and Welfare from 8 different institutions/organizations including THL, Ministry for health, different hospitals and research organizations.

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