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A swine flu vaccine which has been given to thousands of children in Britain may cause the sleep disorder narcolepsy.
Symptoms include excessive daytime sleepiness and nodding off suddenly without warning.
All packets of the vaccine Pandemrix will have to carry a warning about the risk following a ruling by the EU regulator, the European Medicines Agency (EMA).
The EMA, which is currently investigating the effects of the vaccine, has also told doctors to weigh up the potential risks before injecting children against the deadly H1N1 virus.
There have been seven reported cases of narcolepsy in the UK linked to the GlaxoSmithKline vaccine – four of them children.
The condition can also cause temporary muscle paralysis, hallucinations and problems concentrating.
Caroline Hadfield, of Frome, Somerset, believes her five-year-old son Joshua contracted narcolepsy after being vaccinated with Pandemrix last January.
Within weeks of having the jab, Joshua began sleeping 18 hours a day and Mrs Hadfield says his personality completely changed.
Mrs Hadfield, 40, said: ‘I believe this link will eventually be confirmed. I’m very angry about it.
‘I researched the vaccine carefully before agreeing to let Joshua have it and thought I was protecting him. Now he’s saddled with this for life.
‘There should have been more testing before it was rolled out and it should have been destroyed at the first suggestion of any problems.’
Pandemrix is the main vaccine used in this country to protect against H1N1. It was introduced in the swine flu pandemic of 2009. It has been given to six million people and the Government recommended all children under the age of five should have the immunisation during the initial outbreak.
Pandemrix is still being used as the virus remains in circulation, and doses from the Government’s stockpile were rolled out this winter after supplies of the seasonal flu vaccine ran low.
Children were not included in the list of at-risk groups who automatically received the vaccine during the 2010/11 winter, but many parents elected to pay privately for their youngsters to have the vaccine because of a large number of severe swine flu cases in under-fives.
Narcolepsy is a rare condition which affects just 30,000 people in the UK, including 400 children.
The EMA investigation was launched in August last year after a surge in cases of narcolepsy on the Continent following swine flu vaccination campaigns. In France,
25 cases were reported, including 11 in children under the age of 16.
Experts in Finland revealed last month that children who had the vaccination were nine times more likely to develop narcolepsy.
And in Sweden research found the risk was four times greater.
The same effect has not been witnessed in adults given the injection.
The EMA has now ruled that leaflets in Pandemrix boxes must include the words: ‘Preliminary reports from epidemiological studies in two countries have indicated a four to nine-fold increase of narcolepsy in vaccinated as compared with unvaccinated children and adolescents – corresponding to an absolute risk increase of about three to four additional cases in 100,000 vaccinated subjects.’
The label updates are intended as an ‘interim measure’ until the investigation is completed in July, the EMA said.
A spokesman for GlaxoSmithKline said 247 cases of narcolepsy had been reported worldwide.
He added: ‘Further information must be gathered on a potential likelihood of a causal relationship between Pandemrix and narcolepsy before any conclusions can be drawn. GSK is committed to patient safety.’
A Department of Health spokeswoman said: ‘Flu vaccines have an excellent safety record.’
Symptoms include excessive daytime sleepiness and nodding off suddenly without warning.
All packets of the vaccine Pandemrix will have to carry a warning about the risk following a ruling by the EU regulator, the European Medicines Agency (EMA).
The EMA, which is currently investigating the effects of the vaccine, has also told doctors to weigh up the potential risks before injecting children against the deadly H1N1 virus.
There have been seven reported cases of narcolepsy in the UK linked to the GlaxoSmithKline vaccine – four of them children.
The condition can also cause temporary muscle paralysis, hallucinations and problems concentrating.
Caroline Hadfield, of Frome, Somerset, believes her five-year-old son Joshua contracted narcolepsy after being vaccinated with Pandemrix last January.
Within weeks of having the jab, Joshua began sleeping 18 hours a day and Mrs Hadfield says his personality completely changed.
Mrs Hadfield, 40, said: ‘I believe this link will eventually be confirmed. I’m very angry about it.
‘I researched the vaccine carefully before agreeing to let Joshua have it and thought I was protecting him. Now he’s saddled with this for life.
‘There should have been more testing before it was rolled out and it should have been destroyed at the first suggestion of any problems.’
Pandemrix is the main vaccine used in this country to protect against H1N1. It was introduced in the swine flu pandemic of 2009. It has been given to six million people and the Government recommended all children under the age of five should have the immunisation during the initial outbreak.
Pandemrix is still being used as the virus remains in circulation, and doses from the Government’s stockpile were rolled out this winter after supplies of the seasonal flu vaccine ran low.
Children were not included in the list of at-risk groups who automatically received the vaccine during the 2010/11 winter, but many parents elected to pay privately for their youngsters to have the vaccine because of a large number of severe swine flu cases in under-fives.
Narcolepsy is a rare condition which affects just 30,000 people in the UK, including 400 children.
The EMA investigation was launched in August last year after a surge in cases of narcolepsy on the Continent following swine flu vaccination campaigns. In France,
25 cases were reported, including 11 in children under the age of 16.
Experts in Finland revealed last month that children who had the vaccination were nine times more likely to develop narcolepsy.
And in Sweden research found the risk was four times greater.
The same effect has not been witnessed in adults given the injection.
The EMA has now ruled that leaflets in Pandemrix boxes must include the words: ‘Preliminary reports from epidemiological studies in two countries have indicated a four to nine-fold increase of narcolepsy in vaccinated as compared with unvaccinated children and adolescents – corresponding to an absolute risk increase of about three to four additional cases in 100,000 vaccinated subjects.’
The label updates are intended as an ‘interim measure’ until the investigation is completed in July, the EMA said.
A spokesman for GlaxoSmithKline said 247 cases of narcolepsy had been reported worldwide.
He added: ‘Further information must be gathered on a potential likelihood of a causal relationship between Pandemrix and narcolepsy before any conclusions can be drawn. GSK is committed to patient safety.’
A Department of Health spokeswoman said: ‘Flu vaccines have an excellent safety record.’
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