Evidence grows for narcolepsy link to GSK swine flu shot

By Kate Kelland, Health and Science Correspondent

STOCKHOLM | Tue Jan 22, 2013 1:55am EST

Jan 22 (Reuters) - Emelie is plagued by hallucinations and nightmares. When she wakes up, she's often paralysed, unable to breathe properly or call for help. During the day she can barely stay awake, and often misses school or having fun with friends. She is only 14, but at times she has wondered if her life is worth living.

Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy, an incurable sleep disorder, after being immunised with the Pandemrix H1N1 swine flu vaccine made by British drugmaker GlaxoSmithKline in 2009.

Finland, Norway, Ireland and France have seen spikes in narcolepsy cases, too, and people familiar with the results of a soon-to-be-published study in Britain have told Reuters it will show a similar pattern in children there.

Their fate, coping with an illness that all but destroys normal life, is developing into what the health official who coordinated Sweden's vaccination campaign calls a "medical tragedy" that will demand rising scientific and medical attention.

Europe's drugs regulator has ruled Pandemrix should no longer be used in people aged under 20. The chief medical officer at GSK's vaccines division, Norman Begg, says his firm views the issue extremely seriously and is "absolutely committed to getting to the bottom of this", but adds there is not yet enough data or evidence to suggest a causal link.

Others - including Emmanuel Mignot, one of the world's leading experts on narcolepsy, who is being funded by GSK to investigate further - agree more research is needed but say the evidence is already clearly pointing in one direction.

"There's no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries - and probably in most countries," says Mignot, a specialist in the sleep disorder at Stanford University in the United States.

30 MILLION RECEIVED PANDEMRIX

In total, the GSK shot was given to more than 30 million people in 47 countries during the 2009-2010 H1N1 swine flu pandemic. Because it contains an adjuvant, or booster, it was not used in the United States because drug regulators there are wary of adjuvanted vaccines.

GSK says 795 people across Europe have reported developing narcolepsy since the vaccine's use began in 2009.