Finland, Sweden may suspend H1N1 vaccinations after observing tiny uptick in childhood narcolepsy following vaccination

Finland's National Institute for Health and Welfare yesterday said vaccination with Pandemrix, an H1N1 vaccine produced by GlaxoSmithKline, should be halted until a study of side effects including narcolepsy in children is completed. The government’s data showed a half dozen children who were known to have received the vaccine developed chronic sleeping disorders, which is a normal rate. However, nine other cases of childhood narcolepsy have emerged since the beginning of 2010 that might be linked to Pandemrix, the agency said.

A cause-and-effect relationship between Pandemrix and narcolepsy has not been proven. Finland’s health agency said the H1N1 flu itself or other factors such as infection and not the vaccine may have caused the sleeping disorders.

"At the moment we are not having a (swine flu) epidemic, so there is no immediate need for vaccination," according to a statement by the agency. The agency also said it will take pediatric neurologists and public health officials several months to study the relationship between Pandemrix and the sleeping disorders.

Sweden's Medical Products Agency (MPA) has also opened an inquiry into whether vaccinations for H1N1 flu caused narcolepsy in children.

"The MPA has received six reports from health care professionals regarding narcolepsy as suspected adverse drug reaction following Pandemrix flu vaccination," according to an MPA statement. The agency noted that in addition to the reports from medical professionals, citizens had also reported narcolepsy symptoms but the agency did not state how many. "The agency will, in consultation with external experts, assess the possible relationship between the vaccination and the reported reactions."

The physician reports in Sweden focused on children ages 12 to 16 who developed symptoms consistent with narcolepsy one or two months following H1N1 vaccination.

Clinical symptoms of narcolepsy include day-time sleepiness, cataplexy (sudden muscle weakness), hypnagogic (pre-sleep) hallucinations and sleep paralysis (immobility of the body that occurs while waking up and sometimes while falling asleep), according to the MPA.

The MPA says it will coordinate with other European Union member states to see if they received similar reports after vaccination.

About 30 million people in EU countries were vaccinated with Pandemrix following the designation of H1N1 as a global pandemic. Sweden bought 18 million doses, enough to inject each citizen twice.  Finland's National Health Institute vaccinated 2.5 million Finns.