Finland's National Institute for Health and Welfare says there is a link between GlaxoSmithKline's Pandemrix flu vaccine and a spike in narcolepsy cases. Narcolepsy is a disorder that causes a person to fall asleep suddenly and unexpectedly.
"Among those 4-19 years of age who received Pandemrix-vaccine had a manifold increased risk of falling ill with narcolepsy during the eight months following vaccination in comparison to those unvaccinated in the same age group," the health body says in a release. "Based on the evaluation done so far, the National Narcolepsy Task Force finds it probable that Pandemrix-vaccination contributed to the observed increase in incidence of narcolepsy among those 4-19 years of age."
In addition to Finland, an increase in narcolepsy cases was observed in Sweden and Iceland. These preliminary results will be confirmed in Finland in coming months. The Finnish Pharmaceutical Insurance Pool already has said compensation would not be paid on the basis of the preliminary report, the Helsinki Times notes. The body, which is made up of three insurance companies, said 15 claims involving Pandemrix and narcolepsy had been filed.
The World Health Organization was quick to react to the news. "WHO agrees that further investigation is required concerning narcolepsy and Pandemrix vaccine," the World Health Organization said in a statement.
"This (Finnish) investigation is independent of a broader ongoing European Medicines Agency (EMA) investigation initiated in 2010," GSK says in an emailed statement to Reuters. "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."
The final report from the National Narcolepsy Task Force will be released by the end of August.
Late last summer, Sweden's Medical Products Agency announced it was investigating of cases of narcolepsy after vaccination with Pandemrix. The MPA said there were 12 cases of narcolepsy reported from healthcare professionals in Sweden with a suspected relationship to vaccination with Pandemrix.