The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for the flu vaccine Pandemrix should be amended to advise prescribers to take into account preliminary results from epidemiological studies on Pandemrix and narcolepsy, and to perform an individual benefit-risk assessment when considering the use of Pandemrix in children and adolescents. This is an interim measure pending the outcome of the European review, expected to conclude in July 2011.
The CHMP reviewed all available data, including new findings from Sweden and France on the suspected link between narcolepsy in children and adolescents and Pandemrix. The CHMP concluded that, following the earlier results of an epidemiological study from Finland, the new evidence strengthened the signal in children and adolescents, but that the data had methodological limitations. The relationship between Pandemrix and narcolepsy is still under investigation.
The CHMP is working with experts from across the EU to assess the possible safety concern and any impact on the benefit-risk balance of Pandemrix. The CHMP plans to hold a meeting with participation of international experts, the World Health Organization (WHO), and the ECDC.