Author: Niharika Rozwal, National Law School of India University, Bangalore
Introduction:
The COVID-19 pandemic has claimed over 80 million lives worldwide with new infections rising every day. Vaccine developers around the world are in a race to develop a vaccine that provides immunity against the virus. Currently, there are more than 50 vaccine candidates in various stages of clinical trials. Vaccines by Pfizer, Moderna, Sinovac and few others have already received emergency use authorisations (EUA) in United States, UK, Russia and China. India, too has sanctioned emergency use authorisation for two vaccines, Covaxine by Bharat Biotech and Covidshield by Serum Institute of India.
Legal Issues:
The interim Phase III results of the Oxford-AstraZeneca’s Covidshield have been published along with the data on its efficacy and adverse effects. However, India’s COVAXIN has been authorized for ‘restricted emergency use’ despite the lack of data on the efficacy of the vaccine and its Adverse effect following immunisation (AEFI). In fact, the Subject Expert Committee has sanctioned the use of Covaxine in a ‘clinical trial mode’ as a qualifier, the meaning of which still remains unclear. Phase III and IV trials have been accelerated and are now taking place parallel to the vaccine being rolled out for the public. This is a deviation from the usual course where a clinical trial takes place first, before rolling out the vaccine for widespread use. The recently introduced New Drugs and Clinical Trials Rules, 2019 also play the role of a catalyst in facilitating early rollout of the vaccines. The emergency use authorisation of vaccines thus, raises various legal and ethical concerns.
Unlike some other authorities, like the United States’ Food and Drug Administration that sanctioned EUA, India neither has an emergency use protocol in place for the rollout of vaccines in public domain nor does the word ‘emergency use authorization’ appear in any legislation. In order to facilitate the introduction of the vaccines, the government introduced the New Drugs and Clinical Trial Rules, 2019 in March, 2019. The new rules have made relaxations in the need for an ethics committee in a clinical trial under rule 25(ii). They have waived off the provision for ‘No Fault Compensation’ limiting the responsibility of the Sponsor in cases of injuries and death due to adverse effects from the vaccine. They also restrict the right to appeal of the trial participants in matters of compensation for serious injury or death, which were earlier available to them. The healthcare workers and others getting the Covaxine in ‘clinical trial mode’ will be governed by these new rules with limited protection and compensation in cases of injury, death or adverse effects following immunisation.
Ethical Issues:
These vaccine trials are blinded in order for the scientists and researchers to gain unbiased data and comparative evaluation of the experimental drug. The trials are conducted on two groups of participants, one is the controlled group which is administered the vaccine and the other is a placebo group, to which the vaccine is not administered.. However, if the vaccine is made available for the public at large, the vaccine developers will have an ethical responsibility to inform the placebo group that they did not receive the vaccine. This will disrupt the long term data needed for efficacy comparison of the vaccine and placebo arm of the clinical trial. Thus, un-blinding of clinical trials will certainly disrupt the available data on vaccine’s efficiency and efficacy.
The deployment of these novel Covaxine based only on the safety and immunogenicity data generated by the phase I and II clinical trials breaches some of the most fundamental principles of bioethics. Scientist and researchers are concernedabout the long term assessment of vaccine’s safety and efficacy if it is made widely available without the completion of the ongoing trials.
Bioethics is based on four basic principles: justice, beneficence, non-maleficence, and respect for autonomy; and these trials have violated all four principles.
The principle of justice pertains to the fairness in distribution of the vaccine and careful systematic selection of trial participants from different backgrounds is an integral part of it. The principle of autonomy or respect for persons requires the trial participants to be treated as autonomous agents and provided with requisite information and protection. The COVID-19 pandemic has worsened the existing social and health inequalities in India, the effect of which will probably be reflected in the vaccine distribution raising concerns about distributive justice.
Under the Belmont Report, autonomy meant that people are entitled to making their own free, independent, and informed choices. It was reported that the trial participants for COVAXIN in Bhopal were selected from underprivileged areas without informing them that they were test subjects. Moreover, these participants were illiterate and alleged to have signed the consent forms unknowingly with no facility taking an audio visual recording of their consent. They were not given adequate information about the side effects of the vaccine and post administration, many of these participants did not have resources to communicate their adverse effects to the authorities. Thus, the manner in which these trials are being conducted hardly adheres to the principle of autonomy.
Non-maleficence or ‘do no harm’ has been extended to entail that a person must not be injured regardless of the benefits that might come to others. The authorisation of COVID-19 vaccines without a thorough scrutinization of phase III trial data would potentially put a large number of people at a risk of less known adverse effects of the vaccine. Since the vaccination drive, concerns regarding lack of transparency in making the trial data public, incidents of side effects from the vaccine, research pointing towards long term neurological effects, have surfaced across the world.
The principle of beneficence, in this case, requires the delivery of an efficacious product that benefits the trial participants, the society at large. The above two principle are closely intertwined and unless a vaccine that provides effective prevention from the COVID-19 virus is manufactured based on the data from all the phases of a well conducted clinical trial, beneficence will hardly be fulfilled.
Conclusion
Despite the need for an urgent immunization response to the COVID-19 virus, the importance of adherence to these ethical standards should not be side lined by the government. The focus should be on developing an effective and efficacious vaccine supported by strong scientific data. The risks of a vaccine circulated without complete data on its long term adverse effects might do more harm than good.
Comentarios