Study finds Narcolepsy Link to H1N1 Vaccine

French researchers have found a significant link between one 2009 H1N1 vaccine and narcolepsy in adults, a finding that is likely to prompt some countries to take a fresh look to see if adult cases have surfaced in the wake of pandemic vaccine campaigns.

The French findings are part of a larger investigation under way through the Vaccine Adverse Event Surveillance and Communication (VAESCO) Consortiu led and funded by the European Centre for Disease Prevention and Control (ECDC). The data are from a case-control study that was partially included yesterday in a detailed technical report from the ECDC that explored the vaccine-narcolepsy link in eight European countries, including some that didn’t report the problem.

Full findings from the French case-control study appeared recently on the Web site of the French Agency for the Safety of Medicines and Health Products (ANSM), a group that is similar to the US Food and Drug Administration.

Only one vaccine has been linked to the narcolepsy cases, Pandemrix, a GlaxoSmithKline (GSK) product that contains its AS03 adjuvant. The vaccine was not used in the United States during the 2009 H1N1 vaccine campaign, but several European countries used it alone or alongside other vaccine formulations. Canada and Brazil also used a very similar GSK pandemic vaccine containing the AS03 adjuvant.

A recent ECDC report confirmed the link between narcolepsy and pandemic 2009 vaccination in Finnish and Swedish kids, and reported that a sensitivity analysis found a narcolepsy link to vaccinated adults when data were pooled from countries that hadn’t already noted an association.

The ECDC said more data and case reports will be needed to better understand the link between narcolepsy and the vaccine.

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