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Feature Informed Consent

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

BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m734 (Published 26 February 2020) Cite this as: BMJ 2020;368:m734

Linked Analysis

WHO’s rollout of malaria vaccine in Africa: can safety questions be answered after only 24 months?

  1. Peter Doshi, associate editor
  1. The BMJ
  2. pdoshi@bmj.com

Experts are troubled by the apparent lack of informed consent in a large, cluster randomised study of the malaria vaccine. Peter Doshi reports

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.2

Charles Weijer, a bioethicist at Western University in Canada, told The BMJ that the failure to obtain informed consent from parents whose children are taking part in the study violates the Ottawa Statement, a consensus statement on the ethics of cluster randomised trials, of which Weijer is the lead author, and the Council for International Organizations of Medical Sciences’ International Ethical Guidelines. “The failure to require informed consent is a serious breach of international …

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