Covid-19 vaccine - Human trials and ethical concerns

It has been more than 10 months since the first covid-19 case was reported, and currently, more than 150 vaccines are under development across the world to get rid of this world crisis. The human trials of the vaccine are occurring in many countries but, with that came forward various ethical concerns. Human experimentation is the employment of human beings as specimens for research and investigation, which is clinical research that requires the consent of the subjects, and experimentation without consent is considered 'unethical.'

Vaccine development

172 countries are involved in the manufacturing of the corona vaccine and then equal access to the safe and effective vaccine to the world after approval of the license. Several covid-19 candidates are in the race to create the vaccine for the elimination of the virus and a few of them have reached phase three and beyond like, Bharat Biotech, Novavax, Johnson & Johnson, Moderna Therapeutics, Pfizer, University of Oxford, Sinovac, Sinopharm, Murdoch Children's Research Institute, CanSino Biologics, and The Gamaleya National Center of Epidemiology and Microbiology. The vaccines created by these candidates have gone for clinical trials and have shown significant immune responses. But it is still not clear which candidate's vaccine will be an ultimate success. 

Human Challenge trials

Amidst the coronavirus pandemic, UK will be the first country to carry out Human challenge studies in January, in which 90 healthy people will be exposed to the coronavirus. The volunteers of young age and good health will be infected with the coronavirus through the nose and will be observed around the clock, keeping their safety as the primary concern. Volunteers for human challenge trials are set to be purposely infected with Coronavirus as it will speed up the development of a vaccine.

The ethical challenge studies involve a range of requirements like scientific rationale, the minimum risk for participants, and detailed informed consent ethical guidelines. 

The risks

There are major difficulties in any SARS-CoV-2 human challenge trial study. The challenge studies are ideally done in situations where the disease caused is expected to be mild and where the infection can quickly be treated and eliminated if the need arises. But in the case of Covid-19, there is no absolute cure that means that even the young and healthy people who are considered low-risk can become very ill or even die. Ethically, the volunteers should under no circumstances be exposed to the risks of irreversible, incurable, or possibly fatal infections. But the covid-19 challenge studies fail to satisfy this essential ethical requirement as the mortality rate for Covid-19 is too high across the world. Also, as being said, covid-19 can affect many organs other than the lungs, leaving some patients with lasting disabilities. 

According to WHO, the consent of the subjects in human challenge studies is the key requirement. This also means that they should be provided with all the relevant information about the risk they are considering. 

Ethical concerns

The research subject for the Covid-19 vaccine in development sites includes subjects from various countries, like USA, Russia, Argentina, Brazil, Germany, India, Saudi Arabia, Pakistan, and others. The safety, tolerability, and effectiveness of the vaccines should be obtained from different geographic areas, ethnicities, prevalence, and varieties of the virus circulating in the areas. 

The possible exploitation of vulnerable people from less developed countries can be an ethical concern for a vaccine trial. The trial should give them an impartial advantage in trade, such as capacity building, transfer of technology, and access to the vaccine during the current pandemic of COVID-19. 

Another concern is the availability of health facilities to ensure that trial subjects and their families and the communities have access to treatment and proper care in case of serious adverse effects related to the trial outcomes.