GlaxoSmithKline swine flu vaccine Pandemrix has been linked to narcolepsy in young people and should be used as a last line of protectionThe agency recommended that in persons under 20 years of age, Pandemrix may only be used if other jabs are unavailable and immunisation against H1N1 is still needed.
A review of the vaccine by European Medicines Agency’s Committee for Medicinal Products for Human Use was initiated to investigate the link between Pandemriz and the narolepsy following an increased number of reported cases of the sleep disorder among children and adolescents in Finland and Sweden.
The results indicated a six to 13-fold increased risk of narcolepsy in vaccinated children or adolescents, compared with those who were unvaccinated.The Committee for Medicinal Products for Human Use noted that similar epidemiological studies have not been completed in other countries. It said in a statement, “The preliminary results of the study confirmed the signal in Finland. Results are still preliminary and do not allow conclusions in other countries (where vaccination coverage with Pandemrix was lower).”
The committee confirmed that, overall, the benefit-risk balance of Pandemrix remains positive.GlaxoSmithKline is carrying out a retrospective cohort study in Canada, where an equivalent H1N1 vaccine (Arepanrix) was widely used.Pandemrix was the most widely used in the UK during the 2009/10 flu pandemic, but the vaccine is no longer in use and the remaining stocks will be destroyed this year.