SpainSpain

Gardasil vaccinations to continue

26.02.2009

Madrid - The distribution of cervical cancer vaccine Gardasil in Spain is likely to recommence soon. The European Medicines Agency (EMEA) has reviewed the available information on the two cases of status epilepticus with myoclonus (repeated and prolonged seizures and loss of consciousness) reported in two girls vaccinated with Gardasil in Spain. Based on the current data, the Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the cases are unlikely to be related to vaccination with the substance, and that the benefits of Gardasil continue to outweigh its risks. The Committee is therefore recommending that vaccinations should continue in accordance with national vaccination programmes in Member States. Both girls were vaccinated with the same batch of Gardasil, became ill shortly after vaccination, and are now improving. Following the two cases, the Spanish public health authorities in early February took the precautionary measure of halting vaccination with the batch of Gardasil concerned. The Italian authorities stopped vaccination with the batch shortly thereafter, and the distribution of the entire batch was stopped a day later. The CHMP and its Pharmacovigilance Working Party are continuing to investigate the situation. The marketing authorisation holder has been asked to provide a full analysis of the batch, as well as further information on the vaccine's side effects, any similar cases, and possible ways in which Gardasil could be linked to the cases seen in Spain. Following assessment of all available data, the CHMP will determine whether further action is necessary. The Committee recommended an update of the Product Information for Gardasil in January to emphasize information on syncope (fainting) as a possible side effect of vaccination with the substance.

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