WHO reviews GSK H1N1 flu shot after narcolepsy link
By Kate Kelland and Terhi Kinnunen
LONDON/HELSINKI (Reuters) - The World Health Organisation is reviewing the safety of GlaxoSmithKline's Pandemrix H1N1 flu vaccine after a Finnish study suggested children who got the shot were nine times more likely to suffer from narcolepsy, a rare sleeping disorder.
Narcolepsy causes a person to fall asleep suddenly and unexpectedly. Its precise cause is unknown but it is generally considered to be triggered by a combination of genetic and environmental factors.
Researchers at Finland's National Institute for Health and Welfare (NIHW) said on Tuesday their research suggested it was "most likely" the increase they found in narcolepsy was a joint effect of Pandemrix and some other factor or factors.
The research, described as preliminary, was conducted by the Finnish national narcolepsy committee and published by the NIHW. It found an increase in cases of narcolepsy among children aged four to 19 years who had the vaccine.
GSK said it was aware of the research but believed it was "premature" to draw any conclusions. A separate investigation by European drugs regulators is already underway.
The WHO said further investigation was needed into any links between narcolepsy and Pandemrix, and it was working on this.
"WHO's Global Advisory Committee on Vaccine Safety (GACVS) is considering all available data relating to reports of increased rates of narcolepsy and is expected to issue a statement on its website within the coming days," it said.
WHO spokesman Gregory Hartl told a briefing in Geneva that the committee would hold a teleconference on Friday to discuss the data, which they received on Monday. Continued...