The European Medicines Agency posted a statement yesterday saying there have been two sudden and unexpected deaths in young women who had received the Merck HPV vaccine, which is marketed in Europe by Sanofi-Aventis. But the EMEA decided not to change the labeling info, given that 1.5 million women have already been vaccinated in Europe and because no causal relationship between the vaccine and the two fatalities has been found.

One death occurred in Austria and the other in Germany. In both cases, the cause of death could not be identified, says the agency. However, the EMEA will continue to monitor Gardasil for safety issues. The cases were widely reported in the Austrian and German press earlier this month. (Here is a translation of one story that appeared in Der Standard).

This is not the first time that Gardasil, which was the focus of controversy in the US last year after Merck orchestrated a behind-the-scenes campaign to prompt statel lawmakers to push for mandated vaccination, has been the focus of side effect issues. Twice last year, a conservative group, Judicial Watch, trumpeted side-effect reports obtained from the FDA that showed thousands of adverse reactions and several deaths. As of its last report in October, the group claimed the FDA received 1,824 adverse reaction reports, including as many as 11 deaths.