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EMEA recommends Gardasil vaccinations continue

The EMEA has reviewed the information relating to the cases in early February when two girls in Spain became ill after receiving the Gardasil vaccination.

The European Medicines Agency (EMEA) has reviewed the information relating to the cases in early February when two girls in Spain became ill after receiving the Gardasil vaccination.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) has studied data showing that the two girls suffered repeated and prolonged seizures and loss of consciousness. The committee has concluded that the illness in the girls is unlikely to be related to the vaccination and that the benefits of Gardasil continue to outweigh the risks.

As a precautionary measure, Spanish authorities stopped vaccination with the batch of Gardasil from which the girls were vaccinated. Italian authorities also ceased to use the same batch of the vaccine.

A full analysis of the batch will now be provided to CHMP along with further information on the drug's side effects and any similar cases to those in Spain. Once the further analysis is complete, CHMP will report on any action needed.

Gardasil, which is also marketed in the EU as Silgard, is a vaccine for the prevention of cervical cancer caused by human papillomavirus (HPV). It has been used to vaccinate around three million girls in the EU since it was first authorised in 2006.

21st February 2009

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