Informed Consent
Commentary: Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease
SYNOPSIS
The risk antibody‐dependent enhancement (ADE) during COVID-19 vaccine trials was sufficiently obscured in clinical trial protocols and consent forms that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.
CITATION
Timothy Cardozo; Ronald Veazy; Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease. International Journal of Clinical Practice. October 28, 2020; https://doi.org/10.1111/ijcp.13795
SUMMARY
COVID‐19 vaccines designed to elicit neutralizing antibodies may sensitize vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralizing antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID‐19 disease via antibody‐dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID‐19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.
WHO’s malaria vaccine study represents a “serious breach of international ethical standards”
SYNOPSIS
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.
CITATION
SUMMARY
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.
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. 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.
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 ethical standards,” he said.