Swine flu vaccine safety probed over link to rare sleep disorder
The safety of a swine flu vaccine is to be investigated by European drugs regulators after it was linked to a rare condition that causes people to fall asleep suddenly.
The investigation has been prompted after health officials in Finland announced they were suspending the vaccination programme there following reports of narcolepsy in people who had received the jab.
So far there have been 27 reports of suspected narcolepsy in people across Europe who had previously been vaccinated with Pandemrix, the H1N1 swine flu vaccine made by GlaxoSmithKline.
No cases have been reported in Britain.
In total more than 30m people in the European Union have been vaccinated with Pandemrix.
Narcolepsy is a rare condition and its causes are unknown. It can be dangerous if sufferers fall asleep while driving or operating machinery. It is thought there are 25,000 people with the condition in Britain but experts have estimated that 80 per cent of sufferers have not been diagnosed.
Once diagnosed with the condition, which is long-term and has no cure, people are not allowed to drive.
The investigation will examine if Pandemrix was the likely trigger for the condition or whether it was a coincidence.
Finland suspended its national vaccination programme on Tuesday after eight suspected cases of narcolepsy following administration of the jab. A further ten cases have been reported in Sweden, six in France, and one each in Germany and Norway.
The European Medicines Agency will now investigate if there is any link, including how many people would normally be expected to suffer narcolepsy so this 'background rate' can be compared to with the number of cases observed after vaccination.
The Agency is also liaising with the European Centre for Disease Prevention and Control, other drugs regulators and the World Health Organisation.
A spokesman for GlaxoSmithKline said: "Information surrounding the reported cases remains limited at the current time. GSK is conducting its own investigation in an effort to gather as much additional data as possible regarding the observed cases and is working closely with the regulatory authorities, including the European Medicines Agency (EMA)
"Global experience with previous large-scale immunisation programmes has shown that it is likely that a certain level of adverse events will be reported. The adverse events that are reported may be the result of underlying conditions, or new conditions that occur in temporal association with the vaccination, and some events may be related to the vaccine.
"Having reviewed the currently available data and information regarding the reported cases of narcolepsy, which remains limited at this time, as well as GSK’s own safety database, the Company has concluded that the currently available information is insufficient to assess the likelihood of a causal relationship between Pandemrix and narcolepsy."
