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news.The Committee for Medicinal Products for Human Use (CHMP), on behalf of the European Medicines Agency (EMA), has concluded that the available data are insufficient to demonstrate a causal relationship between GlaxoSmithKline's (GSK) Pandemrix and the observed cases of narcolepsy.
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CHMP has further concluded that any temporary restriction on the use of Pandemrix is not considered warranted.
The CHMP has recommended to continue all the ongoing analyses in Sweden and Finland and has also recommended to expand the current investigation to incorporate epidemiological analysis.
GSK Biologicals chief medical officer Norman Begg said that in addition to working closely with the regulatory authorities, including EMA, they would also continue their own investigation in an effort to gather additional data and information regarding the reported cases.
GSK claimed that over 30 million doses of Pandemrix have been administered throughout Europe, to date, with the most recent EMA Pharmacovigilance Report concluding that the benefit-risk profile of the three centrally-approved H1N1 vaccines, including Pandemrix, continues to be positive.