A flu vaccine given to millions of Britons as recently as a few months ago will no longer be used after watchdogs found it increased the risk of children developing a serious sleeping disorder.
Pandemrix has been deemed unsuitable for anyone under the age of 20 after studies showed it could trigger narcolepsy – a rare disorder which causes a person to fall asleep suddenly and unexpectedly, with potentially dangerous consequences.
The European Medicines Agency advised that the jab should be given to children and teenagers only if other vaccines are unavailable and they still need protecting against the H1N1 swine flu strain.
More than six million doses of Pandemrix have been given, several million of them to children, and many during the height of the swine flu panic of 2009/10.
The jab, made by GlaxoSmithKline, was still being given to children last winter during the seasonal vaccination campaign.
At least ten cases of narcolepsy linked to the vaccine have been reported to the UK regulator, the Medicines and Healthcare products Regulatory Authority.
Last night the UK medicines watchdog said its stocks of the vaccine will run out in October – meaning they will not be used for the seasonal flu vaccinations this winter. It follows an investigation into reports from Finland and Sweden of children and adolescents suffering narcolepsy.
Studies found a six- to 13-fold increased risk of narcolepsy in children and adolescents who had been given Pandemrix compared with unvaccinated children. But the EMA said the overall risk-benefit balance of the drug remains positive.
No increased risk was found in adults over the age of 20. It added the vaccine ‘is likely to have interacted with genetic or environmental factors which might raise the risk of narcolepsy, and other factors may have contributed’.
The vaccine has been given to more than 31million people worldwide.
In April the Mail reported British mother Caroline Hadfield’s claim that the vaccine had given her son Joshua narcolepsy.
Within days of being given the jab in January last year, the five-year-old began sleeping for 18 hours a day and falling over when he felt a strong surge of emotion. His teachers were forced to put a bed in the canteen, and his parents had to bring him home in a pushchair because he could not manage the two-minute walk.
An MHRA spokesman said: ‘The regulatory action for Pandemrix vaccines recognises the potential seriousness of H1N1 infection and ensures the vaccine remains a licensed alternative to protect children.
‘However, as the shelf-life of remaining UK stocks of Pandemrix expires in October this year, the vaccine will not be used in the 2011/12 flu vaccine campaign.’
A statement by GSK said 335 cases of narcolepsy in people vaccinated with Pandemrix have been reported to it as of this month and it is ‘committed’ to conducting further research.
It added: ‘GSK is committed to patient safety and will continue to work closely with the EMA and other national regulatory organisations in the best interest of patients.’