The agency’s Committee for Medicinal Products for Human Use (CHMP) reviewed the date from Finland’s National Institute for Health and Welfare (THL) which showed a connection between children and young people’s use of Pandemrix and subsequent development of narcolepsy.
THL’s research showed that narcolepsy was nine times more common among children and young people who received Pandemrix than it was among those who did not.
CHMP concluded that the data added to concerns, but was not enough to prove that pandemrix caused a higher risk of narcolepsy. They added that although THL’s study was well-designed, there remained a possibility that other factors could have affected the narcolepsy risk.
The committee pointed out that the apparent link in Sweden and Finland had not been replicated in Canada, which has seen heavy use of Pandemrix. Further research is being conducted by the European Centre for Disease Control and Prevention (ECDC) in nine European Union countries, and the reports should be available in June 2011.
Rise in Narcolepsy Cases Potentially Linked to H1N1 Vaccine
