The swine flu vaccine which has been given to thousands of children can cause a sleeping disorder known as narcolepsy. The symptoms of the condition may include dozing off suddenly without any warning and excessive sleepiness during day time. The European Medicines Agency (EMA) says that all packets of the vaccine should carry a warning about the risk.
The vaccine Pandemrix can also cause temporary muscle paralysis, delusions and problems relating to concentration. Pandemrix is the main vaccine that is used to protect against H1N1. It was introduced in the swine flu epidemic of 2009. The vaccine has been given to millions of people and Government suggested all kids under the age five should be immunized during initial epidemic.
The EMA is presently examining the effects of the vaccine, have also told doctors to evaluate the potential risks prior to immunizing kids against the deadly H1N1 virus. Narcolepsy is a rare condition which affects just thirty thousand people in the UK, including four hundred kids.
There have been reported seven cases of narcolepsy in UK related with vaccine by the GlaxoSmithKline among those four cases were of kids. Pandemrix is still being used as the virus remains in circulation. The investigation by EMA was launched in August last year after a surge in cases of narcolepsy on the Continent subsequent to swine flu vaccination campaigns.
More than twenty-five cases were reported in France, including eleven cases of kids under the age of sixteen. Experts in Finland found last that kids who had had vaccinated were nine times more prone to develop narcolepsy and in Sweden the risk was found to be four times greater. The similar effect has not been witnessed in adults given the vaccination.
Now, the EMA has ruled that flyers 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, equivalent to an absolute risk increase of about three to four additional cases in one lakh vaccinated subjects.
According to a spokesman for GlaxoSmithKline nearly two hundred and fifty cases of narcolepsy had been reported globally. More information should be collected on a potential possibility of a causal relationship between Pandemrix and narcolepsy before any conclusions can be drawn. GSK is committed to patient safety.