• Kakoli Nath

HUMAN CHALLENGE TRIALS: AN IMPERATIVE AMIDST COVID-19 ?

INTRODUCTION


An ideal period of over four years is estimated to introduce a vaccine for public use. However, with the COVID-19 pandemic, such an elongated time to introduce vaccines would be counterproductive and detrimental to the health of millions globally. The debate concerning the engagement of human challenge trials in an attempt to speed up the testing period for a coronavirus vaccine has become a matter of deliberation by governments and human rights organizations worldwide. Multiple platforms have been created for participants to volunteer for such trials whenever the vaccine is introduced and ready for testing in Phase III. The World Health Organization's statement acknowledging the practice of human clinical trials is especially essential when governments have abstained from stating their positions regarding the viability of such tests in approval processes. Justice considerations also need to be considered before allowing for such a move, which could include community engagement, selection of participants, robust informed consent, and payment that compensate for time and inconveniences.


Human challenge trials are experiments in which virulent organisms are administered to healthy individuals who deliberately induce infection. Such tests are not novel and have been practiced through centuries, especially during the battling times of cholera, malaria, yellow fever, smallpox. Prima facie, such a voluntary administration of contagion, is contrary to the medical principle of 'no harm' and raises ethical arguments against such an intentional act. However, when addressing this issue from a utilitarian perspective, there can be a justification for such an action, provided there are compelling reasons to study better these microbes for which a full treatment is available, as was the case in human testing for malaria. In the COVID-19 pandemic, given that there is no therapeutic cure for the disease per se, skepticism has arisen concerning the ethics of performing human challenge trials when the magnitude of risk, involving intentional harm to the volunteers has no assured medication for recovery. For a disease as widespread and infectious as the Novel Coronavirus, there is no guaranteed treatment available that can be relied upon to halt the progression of this fatal respiratory illness.



Thousands of people voluntarily signed up participating in such trials conducted on themselves; the same has not approved by any regulating agencies such as the FDA in the US or the CDSCO in India. The argument that most of the volunteers who will be called for such clinical testing would belong to the younger age bracket because of the presumption that their susceptibility to the virus is limited when compared with those of the elderly whose immune system is relatively weaker. However, if only a specific section of the population is allowed to undergo the clinical trials, the long-term impacts/side-effects of the vaccine (if any) on the other age-groups of the people would not be tested, especially the elderly who are more vulnerable to the virus.



Often, comparisons have been drawn between the human challenge trial volunteers and soldiers who are encouraged to take personal risks for the higher cause of the nation. Firefighters, organ-donors, medical staff, doctors, police, municipal workers are all encouraged to risk their lives for the betterment of the rest.



It is peremptory to note that only 'truly informed consent' is ensured for an ethical framework to be maintained during such trials. The level of information gained through the experiment should satisfy the magnitude of risk to the human subjects by ensuring sufficient foresight, thought, and adequate supervision, thus preventing any preventable harms during the process. It is peremptory to note that these human challenge trials are being vigorously supported by the political establishment, which is deeply concerning. The quest for vaccine development is rooted in capitalist relations since that provides a tremendous profit incentive to the corporations that manufacture them and the general concern in ruling circles about promoting a back-to-work policy.



The human challenge trials become a facilitator for both purposes. The attempt of Israel to patent its recently developed microcolon antigen that can potentially cure the COVID-19 disease is an alarming example of the capitalistic incentive to maximize profits out of such a novel treatment. The attempt to expedite trials has led to abject failures in the past, which in the long run only delay the need to determine which therapeutics and vaccines will work and are inherently safe and present adverse profiles.



An ethical consideration will be satisfied if there be adequate provisions made available for volunteers to compensate them for their time in conducting these experiments and compensatory reliefs in case of any extreme hardships faced by the person or his/her family caused directly as a result of being injected the disease. Such an equitable approach, although not satisfactory in terms of lost life (in extreme circumstances) or severe disability, would justify undertaking such a fatal experiment.



In essence, because the extent of the disease is global with all countries striving to invent the path-breaking vaccine for SARS-COV2, these multiple vaccines need to be simultaneously injected into different volunteers to find out which vaccines function their effectiveness needs to be accordingly monitored. An international organization ought to be responsible for such monitoring, especially in a pandemic, with international efforts to develop the vaccine to neutralize the virus.



Countries need to work in harmony to cure the ailment instead of resorting to blame-games and below the belt remarks. Amid such a furor, it becomes mandatory to adhere to scientific principles. Even in desperate times like these, ethical medical principles will save time, life, and resources.



SUBMITTED BY-

Dhanishta Mittal

NALSAR, Hyderabad

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