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Published on 25 January 2008

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EMEA backs vaccine despite deaths

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The European Medicines Agency (EMEA) is supporting the use of a cervical cancer vaccine despite two young women dying after receiving it.

But the regulator said it will continue to monitor Gardasil (human papillomavirus vaccine recombinant) as part of its standard safety checks.

One of the women died in Germany, while the other died in Austria.

But the EMEA said: “In both cases, the cause of death could not be identified.

“No causal relationship has been established between the deaths of the young women and the administration of Gardasil.

“The two European cases were reported as part of the continuous monitoring of the safety of medicines.

“On the basis of the currently available evidence, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) is of the opinion that the benefits of Gardasil continue to outweigh its risks and that no changes to its product information are necessary.”

Gardasil, which is manufactured by Merck, works by protecting women against the sexually transmitted infection human papillomavirus (HPV), which causes around 70% of cervical cancer cases.

More than 2,700 British women are diagnosed with cervical cancer each year, and some 200,000 women also have pre-cancerous changes to their cervix identified by smear tests.

Copyright © PA Business 2008

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