In April this year, during a French television debate in which two doctors considered whether a tuberculosis vaccine might be effective against SARS-CoV-2 (the causative virus of COVID-19), Dr Jean-Paul Mira – head of intensive care at Hôpital Cochin, Paris – said: ‘If I can be provocative, shouldn't we be doing this study in Africa, where there are no masks, no treatments, no resuscitation?’ (BBC News, 2020). Having begun digging this ethical hole, Mira continued to excavate: ‘A bit like as it is done elsewhere for some studies on AIDS. In prostitutes, we try things because we know that they are highly exposed and that they do not protect themselves.’ Following an outcry, including accusations of racism, Mira apologised (BBC News, 2020a).
However, four months later, Prof Jerome Singh – Head of Ethics and Law at the Centre for the AIDS Programme of Research in South Africa – argued that COVID-19 candidate vaccine trials should take place in Africa (Singh, 2020). For example, Singh (2020) notes that with 56% of its urban population living in overcrowded slums, and only 34% of households on the continent with basic hand washing facilities, the African continent is especially susceptible to COVID-19. Further, citing Africa's history in hosting and conducting vaccine trials, plus the contributions already made by African scientists to COVID-19 vaccine development, Singh (2020) argues that including suitable African host countries in vaccine trials would honour the principle of collaborative partnership. But this is not supported by the World Health Organisation (WHO) Director General who asserted that Africa ‘cannot and will not be a testing ground for any vaccine’, and that ‘the hangover from a colonial mentality has to stop’ (BBC News, 2020b).
Does recruiting prisoners for COVID-19 vaccine trials present any less controversial ethical dilemmas than that posed by Africa? This is considered by Strassle et al (2020), noting that the possibility is being explored in the United States by the National Institute of Allergy and Infectious Diseases. According to Strassle et al (2020), proponents advance three arguments favouring the enrolment of prisoners in vaccine trials: early access to a potentially effective vaccine; opportunities to participate in medical research; and a shortening of the time needed to study vaccine efficacy, if transmission rates are higher in prisons than elsewhere.
Nevertheless, Strassle et al (2020) urge caution, pointing out that some prisons do not meet minimum clinical care and public health standards; the benefits of participation in such research are not guaranteed because investigational vaccines may fail rather than succeed; and the risks of participation may be increased in prisons with limited or no on-site clinical resources for individuals with COVID-19 symptoms, complications or severe adverse reactions.
Leaving aside the ethics of COVID-19 vaccine trials in Africa and among prisoners, Holm (2020) addresses the ethics of conducting controlled human infection (CHI) studies with SARS-CoV-2 as part of COVID-19 vaccine trials. He believes it unlikely that the necessary conditions for ethical CHI trials to occur will be met.
Holm (2020) considers two of the conditions specified by a WHO working group that make CHI ethically acceptable: that the research has high social value, and that there is a fair selection of participants. Given that some CHI participants will suffer significant harm, it needs to be demonstrated that such harm is outweighed by the high social value of the research. But social value extends beyond public health benefits to include economic benefits, and Holm (2020) wonders to what extent participants might choose to risk their lives for the often less-emphasised economic benefits conferred by an effective vaccine.
As for the fairness of participant selection, Holm (2020) acknowledges that the WHO advocates excluding participants who are subject to social injustice as that would amount to unethical exploitation, but he nevertheless cites evidence from both low and middle-income countries and high-income countries that on occasion recruitment to phase 1 pharmaceutical trials can involve the exploitation of the socioeconomically disadvantaged, and is inconsistent with any principle of fair selection of participants.
The need for a COVID-19 vaccine is clear, and appropriately conducted trials are essential, but to what extent are we prepared to allow the urgency for completed vaccine trials to outweigh the need for careful consideration of the ethical issues that arise?