In a race to protect billions against coronavirus, numerous institutes and organisations, supported by countries around the world, trying to come up with a Covid-19 vaccine as soon as possible. However, this raises some serious concerns, as conducting human challenge vaccine trials by deliberately exposing the live coronavirus to volunteers can prove fatal, particularly when there is no known cure for the disease. It is also vital to ensure that vaccine is effective and safe when it hits the market.
To win this race, the development process has been rapidly accelerated. According to the World Health Organisation, in August 2020 there were at least 33 potential Covid-19 vaccine candidates in various stages of human trials, while another 143 still undergoing animal tests to determine whether they can be safely administered to humans.
A vaccine goes through multiple stages before being given a green light. A series of pre-clinical and clinical trials (consisting of three phases) follows the initial research and development stage, and each step typically takes two or more years. But some of those steps are being combined, or skipped altogether, to speed up the process.
ISSUES AT THE TRIAL STAGE
A Covid-19 vaccine will be one of the most valuable and eagerly sought-after medical prizes in modern times. The glory attached to this prize calls for a careful look into dangerous practices being used to achieve it and to attain validation from people around the globe. “The reason the Covid-19 vaccine has taken on such political symbolism is that the superpowers have seen the vaccine as projecting their scientific prowess, actually validating their political system as superior”, says Lawrence Gostin, professor of global health law at Georgetown University in the U.S. An 11 August 2020, Russia announced that they had registered the first vaccine against Covid-19, naming it Sputnik V. But there were serious accusations of shortcuts, espionage, unethical risk-taking, and jealousy.
One of the major concerns that has arisen during the stage of the trial itself is that “conducting human challenge vaccine trials by deliberately exposing the live coronavirus to volunteers around the world is not necessary, and unethical, in the absence of proven treatments against the disease”, says Anthony Fauci, one of the lead members of the Coronavirus Task Force in the U.S. Human challenge trials are clinical trials in which participants are intentionally infected with a disease, irrespective of whether they have been vaccinated. They differ from human trials, where volunteers are not deliberately exposed to the virus. However, experts like Stanley Plotkin, an American physician who works as a consultant to vaccine manufacturers, emphasises the importance of human challenges in developing vaccines. According to Plotkin, “human challenge trials can help quickly evaluate the efficacy on a case-to-case basis, and understand the individual immune response in people and it can also help to compare different vaccines head to head”. But a serious question that needs to be addressed is whether this risk is worth taking in light of the negligible amount of information regarding the disease.
PERILS OF ACCELERATED VACCINE
The urgent need for a vaccine is well understood, but it is important to ensure that vaccine is effective and safe. The consequences of doling out a potentially unsafe and ineffective vaccine could be wide-reaching. The perils of advancing into mass vaccination without proper testing can be significant and threatening to the human right to health. One of the possible dangers is the emergence of side-effects. That could result in both a negative impact on health and deterioration of trust in future medical developments. If the vaccine does not protect individuals from infection then those vaccinated could falsely believe that they are protected. The system of methodical series of clinical trials has been built on the hard-learnt lessons of the past, and tampering with these set procedures can risk human health and safety.
OBLIGATION OF STATES
The WHO Constitution (1946) envisages “…the highest attainable standard of health as a fundamental right of every human being.” The human right to the enjoyment of the highest attainable standard of physical and mental health provides binding normative guidance for health-care systems, broader social responses, and global solidarity. The International Covenant on Economic, Social and Cultural Rights (ICESCR), places the burden on states for taking steps towards the “prevention, treatment and control of epidemic, endemic, occupational, and other diseases” and creating conditions to assure “medical service and medical attention in the event of sickness” (Article 12). There are numerous international instruments that recognise the human right to health. Article 25.1 of the Universal Declaration of Human Rights affirms that “Everyone has the right to a standard of living adequate for the health of himself and of his family, including food, clothing, housing and medical care and necessary social services”. However, many states have faced difficulties in ensuring the availability and accessibility of Covid-19-related health coverage. This has meant shortages in essential medical care, including diagnostic tests, ventilators, and oxygen, and in personal protective equipment for health-care workers and other front-line staff. Now, as the race to develop a vaccine is on, the human right to health feels more threatened than ever.
The need of the hour is to effectively ensure that all of the required essential steps are taken to develop a safe vaccine. It is also imperative to ensure that this race towards an accelerated vaccine does not jeopardise the human right to health. The focus should therefore be placed on finding with a vaccine that is both safe and effective to help the entire world return to its old normal.
Pallav is a B.A. LL.B. (Hons.) student at Rajiv Gandhi National University of Law, Patiala. His areas of interest are Human Rights, Criminal Law, and Policy Making. As a community minded person he wants to bring a positive change in the world.