THE EUROPEAN Medicines Agency (EMA) has launched a safety review of H1N1 flu vaccine Pandemrix, which has been given to over 30 million Europeans – including around 20,000 Cypriots – to examine possible links to a rare sleep disorder, it was announced yesterday.
EMA said a limited number of narcolepsy cases have been reported mainly in Sweden and Finland.
“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 EMA said.
On August 24, Finland’s National Institute for Health and Welfare recommended that vaccination with Pandemrix be discontinued until the suspected link with narcolepsy is thoroughly evaluated.
Pandemrix, manufactured by GlaxoSmithKline (GSK), has been authorised in the European Union since September 2009.
It was extensively used during the 2009 H1N1 pandemic, with at least 30.8 million Europeans vaccinated.
The Cypriot pharmaceutical services assured the publis yesterday that there was no cause for concern.
“If it was something serious the EU would have taken serious measures,” said Pantelitsa Koupepidou, the head of the pharmaceutical services.
GSK said in a statement it was conducting its own investigation “in an effort to gather as much additional data as possible regarding the observed cases” and was working closely with regulatory authorities, including the EMA.
GSK said that previous experience with large-scale immunisation programmes had shown it is likely that a certain number of possible side effects, or adverse events, will be
reported among people who receive vaccinations.
“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,” the company said.
Narcolepsy is a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly. Its precise cause is unknown, but it is generally considered to be triggered by a combination of genetic and environmental factors, including infections.
“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,” EMA said.
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.
As part of this evaluation the Committee will also consider the so-called background rate for narcolepsy, i.e. the number of cases that would normally be expected to be diagnosed.
The World Health Organisation, which declared H1N1 a pandemic in June 2009 as it spread around the world, said earlier this month that the H1N1 flu pandemic was over and that the global outbreak had turned out to be much less severe than was originally feared.
