WHO’s malaria vaccine study represents a “serious breach of international ethical standards”

Usage of Mosquirix, the world’s first licensed malaria vaccine, is being limited to pilot implementation due to safety concerns including 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. WHO contends that the study is a “pilot introduction” and not a “research activity” so those children living in areas randomised to receive the new vaccine will do so as part of each country’s routine vaccination schedule and that consent is “implied.” Experts are troubled by the apparent lack of informed consent in a large, cluster randomised study of the malaria vaccine.