Pandemic influenza vaccine Pandemrix under review
This week, medical authorities in Finland and Sweden reported cases of narcolepsy in children and adolescents vaccinated with Pandemrix, produced by GlaxoSmithKline. Other countries have been asked to check their pharmacovigilance databases for any reports of narcolepsy.
The European Medicines Agency (EMA) has launched a review of the vaccine and will look carefully at all available data to determine whether there is evidence of a causal association. While temporal association is apparent, a causal association cannot be confirmed without further studies, which will take some months to carry out. WHO is being kept fully informed of this review.
The WHO Global Advisory Committee on Vaccine Safety emphasizes that, based on current evidence, any relationship between the Pandemrix vaccine and juvenile narcolepsy remains hypothetical. WHO notes that the benefits of vaccines against pandemic (H1N1) 2009 influenza are established and that immunization, to protect vulnerable populations, should continue. Pandemrix remains licensed for use by the EMA and prequalified by WHO.
Updates will be provided as further information becomes available and is assessed.