EMA reviews hypothesis on Pandemrix hypothesis; finalizes on NSAIDs and CV events

The European Medicines Agency's Committee on Human Medicinal Products (CHMP) said Friday that it has reviewed preliminary research results by the Finnish National Institute of Health and Welfare (THL) investigating differences in the immunological response triggered by different pandemic influenza vaccines as a potential root cause for the development of narcolepsy in people given UK pharma giant GlaxoSmithKline’s (LSE: GSK) flu vaccine Pandemrix, for which the CHMP recommended restricted use last year(The Pharma Letters July 22 and passim).

After careful consideration, the CHMP concluded that the data presented by the Finnish researchers are preliminary and that the evidence presented so far is insufficient to allow conclusions to be drawn, and does not lead to any new concerns regarding Pandemrix or other vaccines, including other influenza vaccines. On the basis of the current evidence, the role of the Pandemrix antigen and its adjuvant on the association between Pandemrix and narcolepsy remains unknown.

The CHMP also expects GSK, the marketing authorization holder for Pandemrix, to take into account the hypothesis generated by the Finnish research in its experimental research program into the root cause for the association between Pandemrix and narcolepsy.