# 5275
GlaxoSmithKiline (GSK), the manufacturers of the Pandemrix vaccine which some researchers believe may be linked to an increase in narcolepsy among children aged 4-19 (see Finland: Statement On Pandemrix And Narcolepsy Link), has released a statement of their own today.
With other investigations underway, GSK believes it is premature to draw any conclusions on any link between their vaccine and increases in narcolepsy.
I’ve just excerpted a few paragraphs from this press release. Follow the link below to read it in its entirety.
Update on Pandemrix™ and interim Finnish report on narcolepsy
Issued: 1 February 2011
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.
