Millions of Britons have been given a swine flu vaccine that may be linked to a rare sleeping disorder and is under review by the UK medicines regulator.
The GlaxoSmithKline drug Pandemrix was widely used among high-risk groups, including children and people with long-term conditions, during last year’s pandemic. But a number of narcolepsy cases have been reported in Sweden and Finland.
The Medicines and Healthcare products Regulatory Agency (MHRA) said it was “evaluating” the reports following an investigation announcement by the European Medicines Agency (EMA).
Narcolepsy causes people to suddenly fall asleep, and Finland’s National Institute for Health and Welfare recommended Pandemrix vaccinations should stop until the possible link is fully reviewed. At least 30.8 million people in Europe received the drug.
A MHRA spokesman said it was “aware of the case reports of narcolepsy” and was “evaluating these in collaboration with other EU authorities”.
In a statement, the EMA said: “Although the cases of narcolepsy have been reported in temporal association with the use of Pandemrix, it is at present not known if the vaccine caused the disorder.
“The Agency’s Committee for Medicinal Products for Human Use (CHMP) will look carefully at all of the available data to determine whether there is evidence for a causal association.”
Copyright Press Association 2010