No link found between Pandemrix and nacrolepsy

A preliminary investigation by Sweden’s Medical Products Agency has turned up no evidence of a link between a string of narcolepsy cases and GlaxoSmithKline’s pandemic H1N1 vaccine Pandemrix.

Officials with the Medical Products Agency said they found that narcolepsy had developed both in people who had and who had not received the vaccine, CIDRAP News reports. Medical Products Agency officials also reported that six narcolepsy cases in Stockholm were in children, two of whom had not received the Pandemrix vaccine. Of 10 narcolepsy cases reported in adults, only half had received the vaccine.

Finnish officials have maintained their recommendation that doctors suspend the use of Pandemrix despite the initial findings of the Medical Products Agency investigation by the Swedes. Finnish health officials have received 26 reports of suspected narcolepsy, 21 of them in children younger than 15.

On August 27, CIDRAP News reports, the European Medicines Agency also launched a review of Pandemrix following the reports of narcolepsy through Swedish and Finnish reporting systems. European Medicines Agency officials said they plan to review all the data and determine the background rate of narcolepsy.

Earlier this month, the U.S. Centers for Disease Control and Prevention released a statement on the vaccine-narcolepsy concerns, noting that Pandemrix, which has been administered to 30.8 million Europeans, has not been licensed in the United States.

The CDC said it reviewed information from the U.S. Vaccine Adverse Event Reporting System and found no links between the U.S. pandemic and seasonal flu vaccines to narcolepsy. The agency said it has enhanced surveillance for narcolepsy cases that occur after administration of the 2010-11 seasonal flu vaccine.