Rise in sleep illness cases linked to swine-flu jab
Eight people now suffering from narcolepsy after getting vaccine
Published 27/03/2011 | 05:00
EIGHT Irish people who received the swine-flu vaccine have developed narcolepsy -- the potentially devastating ailment that causes sudden daytime sleep attacks, the Sunday Independent has learnt.
It means that the number of suspected cases of the debilitating sleeping disorder linked with one particular swine-flu vaccine in Ireland has doubled since the beginning of the month.
The Irish Medicines Board (IMB) said: "The IMB has received a large number of suspected adverse-reaction reports and queries in association with the pandemic-influenza vaccines since October 2009, the vast majority of which were consistent with the expected pattern of adverse events for the vaccines.
"Eight reports of narcolepsy-type sleep disorders have been notified in relation to Pandemrix, most of which have been very recently received and are currently being followed up for additional information."
Last August, the vaccination of children and adolescents in Finland with Pandemrix was suspended until a link to narcolepsy had either been ruled out or detected.
The Finnish National Institute for Health and Welfare described the move as a precautionary measure.
Among the eight people in Ireland who have developed narcolepsy sleep disorders is a 10-year-girl from Co Meath who is now on medication to stop her suddenly falling asleep while she is at school.
This newspaper has learned that another young woman in her late teens, who suddenly began suffering from daytime sleep attacks after receiving the Pandemrix vaccine, suffered a nasty facial injury when she suddenly fell asleep while taking a shower.
At the time the young woman began developing symptoms, her worried family were convinced that she was fainting, such was the suddenness of the sleep attacks, which occur in seconds.
But now, following medical tests, the woman's condition has been confirmed as narcolepsy.
In Finland, health officials found evidence of an increased risk of the disorder -- in which people fall asleep without warning or sleep excessively in the daytime -- among those aged four to 19 years who had been given the Pandremrix vaccine.
More than 31 million doses of Pandemrix have been administered in 47 countries around Europe.
The vaccine is manufactured by pharmaceutical giant GlaxoSmithKline.
The IMB said it was now collaborating with a number of other countries to carry out a review of all the available data and information.
Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed that it had reviewed further information from Finland on the suspected link between narcolepsy in children and adolescents and Pandemrix.
"The committee concluded that the new evidence added to the concern arising from case reports in Finland and Sweden, but that the data were still insufficient to establish a causal relationship between Pandemrix and narcolepsy.
"Further analyses and study results are awaited to clarify the observations in Finland."
In addition to the information coming from Finland, research is continuing in Sweden, where there has also been an unexpected number of narcolepsy reports following vaccination with Pandemrix.
In last month's statement, the CHMP said that other non-Nordic countries had not seen similar increased rates of reporting of narcolepsy.
That assessment may change in the light of the eight suspected cases that have been reported in Ireland of people who have received the Pandemrix vaccine and who have subsequently developed narcolepsy.
"Additionally, in Canada, where there has been substantial use of this type of vaccine, there has been no evidence of an increase in reports of narcolepsy.
"Therefore, at present, definitive conclusions cannot be drawn and no changes to the recommendations for use of Pandemrix are proposed," the European Medicines Agency said last month.
The precise cause of narcolepsy is unknown, but it is generally considered to be triggered by a combination of genetic and environmental factors.
The condition occurs naturally at a rate of around one case per 100,000 people every year.