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Gardasil unlikely to have caused Spanish girls’ illness says EMEA

20-Feb-2009

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The EMEA says that the two cases of status epilepticus reported in Spain last week are unlikely to be related to a batch of Merck & Co’s cervical cancer vaccine Gardasil that was withdrawn in the country last week.

Following a review of all available data, the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) concluded that the vaccine had almost certainly not caused the two girls’ reaction.

The Committee recommended that it continue to be used in Spain’s human papilloma virus (HPV) prevention programme and said that its Pharmacovigilance Working Party has requested that Merck and partner Sanofi Pasteur provide a full analysis of the batch in question for further examination.

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