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WHO backs further probes into possible link between H1N1 vaccine and narcolepsy in children

BMJ 2011; 342 doi: http://dx.doi.org/10.1136/bmj.d909 (Published 09 February 2011) Cite this as: BMJ 2011;342:d909
  1. John Zarocostas
  1. 1Geneva

A World Health Organization’s expert panel on vaccine safety has called for more investigations after examining new evidence that indicates children and adolescents faced an increased risk of narcolepsy after being vaccinated against H1N1 influenza with Pandemrix manufactured by GlaxoSmithKline.

The recommendation from WHO’s independent Global Advisory Committee on Vaccine Safety was made after reviewing data from at least 12 countries where Pandemrix has been used, including preliminary findings by Finland’s National Institute of Health and Welfare.

The institute study found, “The risk of falling ill with narcolepsy among those vaccinated in the 4-19 years age group was ninefold in comparison with those unvaccinated in the same age group.”

The advisory committee said an increased risk of narcolepsy “has not been observed in association with the use of any vaccines in the past whether against influenza or other diseases in the past.”

During 2009-10, a total of 60 children and adolescents aged between 4 and 19 years fell ill with narcolepsy, the institute said. Out of these 52 had received Pandemrix.

The risk corresponds to about one case of narcolepsy per 12 000 children and adolescents aged 4 to 19 vaccinated.

Hanna Nohynek, vaccine safety office at Finland’s Institute for Health and Welfare and secretary of the National Narcolepsy Task Force that is conducting the study, said Finland suspended the use of Pandemrix “as a precautionary measure” in August 2010.

The final report is expected to be issue at the end of August.

GSK said in a statement “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.”

More than 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, it said.

Notes

Cite this as: BMJ 2011;342:d909