ABSTRACT
The WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation makes recommendations on the use of placebo controlled trials in ongoing and future Covid-19 vaccine research. These recommendations unequivocally prioritise data quality over participants' rights and safety. Participants in trials of vaccines which have received emergency use listing or authorisation would be refused available vaccines. Placebo-controlled trials that would be impossible to conduct in rich countries would be permitted in poor countries. If these suggestions are implemented, the major beneficiary will be the vaccine industry.
Subject(s)
COVID-19 Vaccines/standards , COVID-19/prevention & control , Ethics, Medical , Patient Rights/ethics , Patient Rights/standards , Placebos/standards , Adult , Aged , Aged, 80 and over , Biomedical Research , Data Accuracy , Female , Guidelines as Topic , Humans , Male , Middle Aged , Pandemics , SARS-CoV-2Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Patient Rights/ethics , Placebos/administration & dosage , Randomized Controlled Trials as Topic/ethics , Double-Blind Method , Humans , Informed Consent , Patient Selection , Practice Guidelines as Topic , Randomized Controlled Trials as Topic/standardsABSTRACT
In this paper present, from a bioethical perspective, a reflection on how to reconcile efforts to combat the COVID-19 pandemic with the safeguard of human rights. To do this, I develop three points. First, the regulatory framework that justifies the restriction or suspension of rights in the face of serious threats to public health. Second, the declarations of the international bioethics committees on the way in which human rights should be protected during public health crisis. And third, a review of the main rights threatened both by the public health crisis and by the means adopted to combat it. Before going into each of these points, I offer a preliminary note to clarify certain legal concepts and underline the need to overcome disjunctive approaches in considering human rights.