Pandemrix, a flu vaccine developed by GlaxoSmithKline (GSK) and patented in September 2006, were investigated due to its potential risk of narcolepsy in children and adolescents. The investigation began in August 2010 conducted by the Swedish Medical Products Agency (MPA) and the Finnish National Institute for Health and Welfare (THL). The report stated that around 6.6 times increased risk among children and adolescents, or about 3.6 additional cases of narcolepsy per 100,000 vaccinated subjects.
The European Union (EU) was suggesting restriction of using the flu vaccine because of the potential risk. Other entity, the European Medicines Agency (EMEA), said that the vaccine should only be used in people under 20 years in the absence of seasonal trivalent influenza vaccines, which has very rare cases of narcolepsy in youth.
During the outbreak of swine flu (H1N1 virus) in 2009-2010, Pandemrix was widely used along with other flu vaccines from Novartis and Baxter. More than 31 million doses of Pandemrix have been given to people in 47 countries, except United States of America. There were 335 cases of narcolepsy in those vaccinated and about two-thirds of the cases were in Finland and Sweden. The researchers from both countries were the first to raise concerns about the possibility of narcolepsy link to Pandemrix after noting cases in children after given the vaccine shot. They also suggested children that given the vaccine shot were nine times more likely to suffer narcolepsy.
GSK, the biggest pharmaceutical company in UK, stated that they committed to conduct research regarding the potential association between Pandemrix and narcolepsy.
References:
- EMEA (European Medicines Agency)
- GSK (GlaxoSmithKline)
- Medscape
- Wikipedia
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