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A swine flu vaccine that was used extensively during the 2009/10 pandemic will no longer be used as the EMA warns it has been linked to narcolepsy in children.
The vaccine, Pandemrix, is manufactured by GlaxoSmithKline and the shelf-life of the current stock in the UK is due to expire in October. The MHRA (the Medicines and Healthcare products Regulatory Agency) has confirmed that Pandemrix will not be used as part of the 2011/12 campaign.
Concerns were raised primarily in Finland and Sweden, but reports have also come in from the UK and Iceland of children developing narcolepsy after receiving the Pandemrix vaccine. Narcolepsy is characterised by the uncontrollable urge to fall asleep without warning. This can occur at any time of day. According to the European regulatory body the EMA (European Medicines Agency), studies have demonstrated that there is a six to 13-fold increase in the risk of children developing narcolepsy when they have been vaccinated with Pandemrix, in comparison to children who have not been vaccinated. Based on this information, the EMA has advised that Pandemrix should only be administered as a last resort. That is, if there are no other flu vaccinations available.
In the UK, there have been ten cases of suspected narcolepsy due to the vaccine reported to the MHRA. In total, GlaxoSmithKline reports that it has received information about 335 cases. More than 31 million people received the vaccination worldwide, six million of which were administered in the UK. The EMA has issued a statement on the issue, noting that “the vaccine is likely to have interacted with genetic or environmental factors which might raise the risk of narcolepsy, and that other factors may have contributed to results.”