EU defends Gardasil vaccine after two deaths

THE EUROPEAN Medicines Agency (EMEA) continued to back the vaccine Gardasil after two women in the EU died unexpectedly after being vaccinated.

In Cyprus Gardasil is marketed under the name Silgard. The vaccine, developed by pharmaceutical giant Merck and first marketed last September, came to Cyprus at the end of 2006. It is said to prevent cervical cancer caused by human papillomavirus (HPV), if administered to women ages 16-26.

The Health Ministry on Friday published a statement by the EMEA saying it had received reports of deaths in women who had previously received the vaccine – under the Gardasil name.

One of the deaths took place in Austria and the other in Germany. The nature of their deaths or how they relate to the vaccine was unclear.

It is estimated that about 1.5 million patients have been vaccinated with this HPV vaccine in Europe, while the total worldwide is believed to be around 13 million. Three women have also died in the US, reportedly as a result of the vaccine.

However the EMEA said that in the two EU 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 statement said.

It said that on the basis of the currently available evidence, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) was of the opinion that “the benefits of Gardasil continue to outweigh its risks” and that no changes to its product information were necessary.
“The EMEA will continue to closely monitor the safety of Gardasil and take appropriate actions should new information emerge that has an impact on the benefit-risk profile of Gardasil,” the statement added.

In the UK, girls as young as 12 will be vaccinated against the virus this year, British press reported.