Human Trials and the COVID-19 Vaccine In India: A Perspective

    The pandemic of Coronavirus has gripped the world yet again. Having originated in China in the year 2019, this virus has bought economies to a complete standstill. In the light of such incredulous events, governments across the world decided to expedite the administration of vaccines and medicines to beat the disease, irrespective of the nature and the efficacy of the medication in the long-run. Vaccine and drugs, which require years to develop so as to evolve and mutate with the pathogens of a virus, were eventually rolled out on an SOS basis. The desperate need of governments to go back to ‘normalcy’ definitely raises questions of accountability and legality of the actions, let alone it being ethical.

    Background on Human Trials:

    Human trials, also known as clinical trials, are conducted on human beings so as to test the effectiveness of a new medicine, drug or vaccine. It consists of new tests and treatments to evaluate the side-effects on health outcomes. Here, human volition is of utmost importance, especially when participating in medical test interventions such as drugs, cell and other biological products, behavioural treatment, etc.

    Earlier, there were no set rules or guidelines set down to regulate this kind of experimentation. An important example of the gross misuse of this lacuna was witnessed during the Holocaust during the Second World War in Germany. Prisoners incarcerated in the concentration camps and ghettos were coerced into unethical human trials. In some cases, the organs from their bodies were unethically harvested for further studies. A substantial number of subjects died due to such experiments. Also, a Nazi scientist named Josef Mengele conducted horrific medical experiments on twins entrapped in the Auschwitz concentration camp.[1]

    Such instances prompted the need to regulate and conform medical trials, especially those which were conducted on humans. This led to the formation of the Nürnberger Kodex or the Nuremberg Code of Ethics. They are basically a set of research ethics and principles enumerated for human experimentation. Born out of the criminal trials conducted at the Palace of Justice, Nuremberg in 1945 against doctors and physicians accused of performing deadly experiments on the prisoners of concentration camps, these ten principles codify and establish the rules that ought to be followed so as to conform to the concept of human rights. They include the right to information, the right against mental or physical harm to the subject, the utility of the experiment for the common good, the qualification of persons conducting the experiment and the right of the subject to opt out of the trial. The tenet of the ten principles revolves around a single fundamental concept: human consent is of the utmost importance.[2]

    Regulation of Human Trials by UN:

    The United Nations, following the Nuremberg Code, designed a set of principles so as to conduct medical and behavioural trials within a specific code of conduct. Clinical Trials, as a result, are now carefully designed and are conducted in 4 phases. The various stages include[3]:

    Phase-I: This includes testing the drugs on a small population so as to determine the appropriate dosage and measure the side-effects.

    Phase-II: This phase entails testing treatment on a larger group so as to monitor any adverse side-effects.

    Phase-III: This stage involves testing on different and larger populations in different regions.

    Phase IV: This phase is conducted after the approval from the parent country and requires widespread testing over a larger time frame.

    Although there are elaborate rules set down by the United Nations, in the form International Clinical Trials Registry Platform, there have been cases of several unethical and often endangering human trials conducted on subjects across the globe. For instance, the Hepatitis E vaccine trial carried out in Nepal by GSK and the Walter Reed Army Institute of Research, which was conducted from 2001-2003 was found to be unethical as the consent was not freely obtained from the subjects as they were poor and illiterate and the beneficiaries of the vaccine were unlikely. Another example would be the trials of Letrozole medicine in India. Letrozole was a globally approved drug for treatment of breast cancer in post-menopausal women but was not recommended for any other use. In 2003, the drug was arbitrarily prescribed to induce ovulation. Conducted by Sun Pharmaceuticals, the trials were deemed unethical as the subjects were inadequately informed about their participation in the trials and the consent obtained was not born out of free will.[4]

    Another terrifying example would be the trial of Thalidomide drug on pregnant women in the late 50s and early 60s which led to the birth of almost 100,000 babies with birth defects.[5] Such instances of population unknowingly being part of clinical trials, some of which directly venturing into phase III or IV, can have dangerous ramifications.

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    The Administration of the COVID Vaccine in India:

    The pandemic of Coronavirus was a defining moment for mankind. The virus infecting an unprecedented number of people forced the government to expedite the production and administration of vaccines in India.

    In 2020, shortly after the lockdown in pursuance of curbing the virus was announced, seven major pharmaceutical companies were racing against time to develop the vaccine for COVID-19. Companies such as Bharat Biotech, Serum Institute of India, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E were instructed to craft a vaccine that would suit the Indian physiological symptoms and effectively provide a shield against the virus. The companies, apart from working with indigenous institutions such as the Indian Council of Medical Research and National Institute of Virology, began collaboration with several international entities such as the Oxford University, the British-Swedish multinational biotechnological company known as AstraZeneca, US- based biotech firm called Codagenix, Griffith University in Australia and an US- based biotechnological firm known as Refana Inc. [6] to develop vaccines in no time.

    In an almost record-breaking measure of time, several phases of the clinical trial of vaccines was concluded within months of the pandemic and was hastily administered to the public at large in a short period of time.

    However, the administration of the vaccine was riddled with set-backs. The first and foremost one was the large-scale production to cater the population of India. The second was dealing with common side-effects of the vaccine. Since they were rolled out rather hastily, a good percentage of people in India and across the world were facing some severe reactions. Reports of headache, fatigue, fever and reaction at the injection site were the most commonly reported side-effects[7]. Another issue that has presented itself is the rumour-mongering regarding the unreported side-effects of the COVID-19 vaccines.

    Questioning the novel vaccine:

    The administration of the vaccine, although done in good faith and so as to save mankind, was riddled with questions and doubts. Vaccines, at large, take years to develop. Even after Phase IV has been completed, the virus is likely to mutate and therefore, the vaccine composition, the proteins and pathogens also undergo changes. Vaccines are developed and redeveloped as per the sensibilities of the population of every region. People living in different parts of the world possess different types of immunities. For instance, it was rumoured that the coronavirus would not affect Indians as potently as it has affected the western countries as most Indians have either administered the vaccine for Malaria or have suffered through Malaria and their antibodies mitigates fatality of the coronavirus to an extent. Despite the rumour, almost 170,209 people have died due to the virus till date.[8] 

    The administration of any drug or vaccine is usually preceded by years of trial and error. There is a need to test the vaccine on people with lifestyle diseases, chronic diseases and the subsequent health outcomes and in some cases, the mortality rate. The degree of surety of combating a virus or disease is of utmost importance.

    In this case, since the vaccines have been underway since only a few months and have produced a significant amount of side-effects amongst the infected and immune population, the question of human rights has been raised. Even if the consent for the pseudo-trial is involved, the overall implications of the vaccine on the health of the patients and subjects alike, were discovered only after the vaccines were administered. To add fuel to fire, the virus developed several variants depending upon the country and continent. The vaccine, even though catering to generalised symptoms, could not be effective upon different variants. As a result, despite the administration of the vaccines, COVID-19 cases have almost doubled in the year 2021, as compared to last year. Countries are going into a lockdown once again and part of the reason is the questionable effectiveness of the drugs.

    A Matter of Human Rights:

    As an observer, one cannot help but notice the obvious lack of human rights in the current situation. The pandemic definitely exposed the inadequate health and financial set-up of several economies such as India and the United States of America. Like dominoes, the departments of the various governments collapsed, one at a time. Despite possessing an elaborate health care system and a disaster management team, India did struggle and to an extent, is still struggling with the onslaught of the rising cases every single day. Economies across the world wanted to desperately recover from this economic development going in minus. Even after proclaiming lockdowns, the cases and the deaths related to the virus have been augmenting. There is an imminent need to go back to normalcy. Therefore governments, including India, have been encouraging people to take the vaccine and in some instances, have made the administration of the vaccine an indispensable condition. Health workers, senior citizens and the labour class are being actively stimulated so as to obtain the vaccine. However, the lack of complete information regarding the effectiveness of the vaccine, the lack of adequate research and the brazen lacuna in imparting complete information to the patients involved is what may qualify this as an unethical trial. According to the Nuremberg Code, consent is of utmost importance. Consent is obtained by divulging complete and unequivocal knowledge regarding the clinical trial and the medicine. In this case, the several phases of the clinical trials are being conducted on people who may or may not be aware of the composition, the effects it may have on their unique health and genes and on the basis of a few pointers, the assent for the vaccine is being obtained when it may not even provide immunity from the coronavirus in the first place. The lack of consent for an activity or volition marked by misrepresentation is a gross violation of human rights.

    Individual Rights v. Group Rights:

    The pandemic of coronavirus has intensified the debate of individual vs. group rights. On one hand, due to lockdowns imposed, all businesses except essential services came to a standstill. In the interest of preserving individual rights, the rights of several groups were suspended. Even after the provision of financial packages and loan moratoriums by the government, several sectors of the economy came to an abrupt halt. A few months after the lockdown was officially and completely lifted, vaccines were administered to revive several sections of the society. Here, group rights are now gaining precedence over individual rights. In order to resume medical facilities, construction sector and manual labour in the country such as India, vaccines and drugs were provided on a priority basis to the frontline workers. They were also provided according to certain age-brackets and the vulnerability of a certain section to contract the virus. Again, group rights or rights of certain sectors are being preferred over the rights of individuals. The fact that vaccines may not suit the entire population is taking a back seat and the approach that ‘something is better than nothing’, is gaining momentum. The precedence of group rights over individual rights is not unethical. However, the fact that such drastic steps have been undertaken to go back to the established order of normalcy is what is irksome. This is the ground of protest for several people against the hastily produced COVID-19 vaccine.

    The issue of economic development and earning money without giving adequate assistance to the population is now becoming more important than administering medicines that may harm the population and their progeny. This is definitely a problematic approach. No doubt, money is important for sustainability but it is a man-made product used as a commodity of exchange. The paper or numbers cannot and should not outweigh the interests of the individual and his/her/their rights.

    Conclusion:

    Churning out medicines and vaccines in a short time is a risky victory. On one hand, you have a somewhat effective shield against the potency of the virus. On the other hand, it would not be very effective if people have acquired herd-immunity. There is a need to impose a regulated form of governance. Sanitisation should be of utmost priority and public gathering, in these extraordinary situations should be curbed as much as possible. The vaccines should be developed to incorporate all the mutating strains and only after they have been properly researched and tested should they be distributed among the general public. The views expressed are not against the vaccine but are seriously questioning the ethics and the legality of the hasty medicine lest it should create an irreversible damage and worsen the pandemic, spreading it to our progeny.

     References:

    [1] Paul Weindling, Anna von Villiez, Aleksandra Loewenau and Nichola Farron, “ The victims of unethical human experiments and coerced research under National Socialism” 40 Endeavour 1(2016).

    [2] Evelyne Shuster, “ Fifty Years Later: The Significance of the Nuremberg Code” 337 The New England Journal of Medicine 1436 (1997).

    [3] Clinical Trials, available at: https://www.who.int/health-topics/clinical-trials/#tab=tab_1 (last visited on April 11, 2021).

    [4] Irene Schipper, “ Examples of unethical trials” Centre for Research on Multinational Corporations (SOMO) 5-7 (2008).

    [5] About Thalidomide, available at : https://www.thalidomidetrust.org/about-us/about-thalidomide/ (last visited on April 10, 2021).

    [6] PTI, “Seven Indian pharmaceutical companies race to develop vaccine for deadly coronavirus”, The Economic Times, July 19, 2020.

    [7] Side Effects of COVID-19 Vaccine, available at: https://www.who.int/news-room/feature-stories/detail/side-effects-of-covid-19-vaccines (last visited on April 10, 2021).

    [8] India, available at: https://www.worldometers.info/coronavirus/country/india/ (last visited on April 12, 2021).


    BY SHARMEEN SHAIKH | SAVITRIBAI PHULE PUNE UNIVERSITY 

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