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Two die after having cancer jab

28th January 2008

Two women have died after receiving the cervical cancer vaccine Gardasil, although the cause of death has not been linked to the jab in either case.

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The deaths, one in Austria and one in Germany, were reported to the European Medicines Agency. The manufacturers - Merck and Sanofi-Aventis - both say there is no link to Gardasil.

The London-based agency said it would not be changing its guidelines on the vaccine, which protects against the human papillomavirus (HPV) which causes most cervical cancers.

It said Gardasil had not been established as a contributory factor in either death.

However, it said it would continue to monitor the vaccine, which has been administered to approximately 1.5 million women in Europe since its launch in 2006.

It would take appropriate action should any new information emerge which affected its appraisal of the risk versus the benefit of having the cancer shot, it said.

Gardasil is a major new product for Merck, with total cumulative sales of US$1.1 billion (£500 million) at the end of September 2007.

Analysts said it was unlikely the deaths were linked to Gardasil, and that regulatory agencies were obliged to consider information of this kind, even if no clear link was demonstrable.

Vaccines are rarely associated with sudden deaths.

Merck said based on the information it had received it did not believe there was a link, pointing to a post-mortem on the German woman which had revealed no link to Gardasil.

The reporting physicians in both cases said there was no link to the vaccine, a spokeswoman said.

Sanofi-Aventis said it fully agreed with the approach taken by the European Medicines Agency, saying there was not causal connection.

 

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