Children should no longer be given a widely-used flu vaccine over concerns it is linked to a rare sleep disorder, the European drug regulator has recommended.
By Martin Beckford, Health Correspondent
10:00PM BST 21 Jul 2011
The European Medicine Agency said that Pandemrix should only be given to the under-20s if they are at risk of contracting swine flu and alternative jabs are not available.
Its announcement comes after studies showed that young people who were given the vaccine were at increased risk of developing narcolepsy, which causes sufferers to fall asleep unexpectedly.
But the British drug watchdog said it would not ban Pandemrix in the young and pointed out that the country’s stocks expire in a few months anyway.
Pandemrix, manufactured by the British pharmaceutical giant GlaxoSmithKline, was given to 30million people across Europe after the outbreak of swine flu – the H1N1 strain of the virus – that started in Mexico early in 2009.
It was approved by the European regulator in September that year but by the following August its safety was being reviewed after health officials in Finland claimed it had been linked to narcolepsy.
In total 335 cases of the sleeping disorder in people vaccinated with Pandemrix have been reported to GSK, with 10 suspected cases out of the 6million doses given in Britain.
In its review, the European watchdog said it looked at all the data as well as taking advice from experts, and found that the results of studies in Sweden and Finland suggested a six to 13-fold increased risk of narcolepsy among vaccinated children.
This means that for every 100,000 adolescents who are given the injection, up to seven are likely to develop narcolepsy.