WHO wants narcolepsy link with swine flu vaccine investigated
pharmafile | February 10, 2011 | News story | Research and Development, Sales and Marketing | Finland Institute, GSK, GlaxoSmithKline, Pandemrix, narcolepsy, swine flu
The World Health Organisation has called for further investigation into GSK’s swine flu vaccine link to sleeping disorder narcolepsy, following a report by the Finland Institute.
A statement by WHO says following 2009’s widespread use of vaccines such as GlaxoSmithKline’s Pandemrix to treat influenza, the rates of narcolepsy reported in Sweden, Finland and Iceland have been higher than in any other country.
Attributing narcolepsy to a genetic linkage, it adds cases of the disease in children and adolescents have been reported in at least 12 countries since August 2010. The public health body repeats claims by the National Institute for Health and Welfare of Finland that those vaccinated between 4-19 years of age, are nine times more likely to develop narcolepsy than those unvaccinated.
Findings from the Finland Institute showed that out of the 60 children and adolescents studied between 2009-10 that fell ill with narcolepsy, 52 (almost 90%) had received Pandemrix.
The report adds that while the association between narcolepsy and Pandemrix requires more investigation, the most likely explanation is that the increased illness is by joint effect of the vaccine and some other factor or factors.
A GSK spokesman told Pharmafocus that it is too early to draw any conclusions from the interim report and that research is still ongoing.
Highlighting a statement it made when the report surfaced last week, GSK said it is: “Working closely with the European Medicines Agency 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,” it added.
GSK points out that over 31 million doses of Pandemrix have been administered worldwide in 47 countries and added: “A total of 162 cases of narcolepsy in people vaccinated with Pandemrix have been reported to GSK as of 31 January 2010; with 70% of these cases of narcolepsy originating from Finland and Sweden.”
The company has submitted draft epidemiological study protocols to EMA for consideration as part of the European investigation on a potential association between Pandemrix and narcolepsy.
The final report from the Finnish National Narcolepsy Task Force is expected by 31 August this year.
Brett Wells
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