Ethical limits to placebo use and access to Covid-19 vaccines as a human right

Abstract

The world is currently facing another severe pandemic, Covid­19, just four decades after the start of AIDS, and the still increasing incidence of HIV infection continues to be one of the greatest global health challenges. The way the latter was confronted is of fundamental importance for a serious discussion on global health, ethics and human rights, and this experience could and can still be applied to Covid­19. The Covid­19 pandemic has specific characteristics and these will be discussed, in relation to vaccine research and especially to the global right to equal access to products proven to be safe and effective. The article focusses primarily on issues related to Covid­19 vaccines, especially the appropriate use and limits on placebo, the right to post­trial access to placebo arm participants, and the use of an active control for subsequent Phase­3 trials after the approval of other safe and efficacious vaccines. Most importantly, it will emphasise that access to Covid­19 vaccines is a human right, which presupposes the establishment of appropriate ethical standards to ensure universal, equal, and affordable access to healthcare and to vaccines for all, and the imperative need for suspension of patents for products developed for Covid­19. It will consider the role of social determinants that contribute to the severity of Covid­19 and that must be addressed to effectively curb the current syndemic.