More data needed to clarify flu vaccine-narcolepsy link
Further studies are needed to clarify a suspected link between use of the swine influenza vaccine Pandemrix and narcolepsy, the European Medicines Agency has said (18 February 2011).
Following its review of preliminary results from a Finnish study, the EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the new evidence adds to the concern arising from case reports in Finland and Sweden, but that the data are still insufficient to establish a causal relationship.
“At present definitive conclusions cannot be drawn and no changes to the recommendations for use of Pandemrix are proposed,” it said.
Given that no such increase in narcolepsy cases has been observed in Canada, where the vaccine has been widely used, one possible explanation for the Finnish results is that Pandemrix may have interacted with an unknown local environmental or genetic factor, the CHMP suggested.
To conclude its review, the committee intends to gather more data from the use of Pandemrix and related vaccines in a variety of countries.
An epidemiological study of narcolepsy and pandemic vaccines is currently being conducted by the European Centre for Disease Control and Prevention through a network of research and public health institutions in nine EU member states. The final results are expected by the end of June 2011.
Citation: The Pharmaceutical Journal URI: 11069296
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