"A large scale malaria vaccine study led by the World Health Organization has been criticised by a leading bioethicist for committing a “serious breach” of international ethical standards. The cluster randomised study in Africa is already under way in Malawi, Ghana, and Kenya, where 720 000 children will receive the RTS,S vaccine, known as Mosquirix, over the next two years.123
Mosquirix, the world’s first licensed malaria vaccine, was positively reviewed by the European Medicines Agency, but its use is being limited to pilot implementation, in part to evaluate outstanding safety concerns that emerged from previous clinical trials.3 These were a rate of meningitis in those receiving Mosquirix 10 times that of those who did not, increased cerebral malaria cases, and a doubling in the risk of death (from any cause) in girls."
