Union Minister Amit Shah’s bold call for a duel to challenge vaccine skeptics came exactly a week after the Indian government’s inoculation program against COVID-19 was launched on 16th January 2021. The ambitious plan aims to vaccinate 300 million healthcare and frontline workers in its first phase using the vaccine derived from the Oxford-AstraZeneca candidate AZD-1222, dubbed Covishield in India, and Covaxin, produced by Hyderabad-based biotechnology company, Bharat Biotech and the Indian Council of Medical Research (ICMR).
Despite initial optimism, the program has witnessed low turnout rates, due to widespread misinformation and safety concerns. The root cause of doubt about the program stems from the announcement by the Drug Controller General of India (DCGI) on 3rd January 2021, when Covaxin and Covishield were given emergency use approvals. While the approval for Covishield was unsurprising, given its established efficacy in all three phases of trials abroad, it was the seemingly hasty rollout of Covaxin that caused a stir.
Criticism of the vaccine primarily focused on the absence of Phase 3 clinical trial data, since the trials have not yet concluded. The initial backlash against the approval of Covaxin was met with officials responsible for India’s COVID-19 response claiming that it would be used as a “back up”, in case of the need for extra doses given the emergence of the new UK strain of the virus. Moreover, it was also made clear that Covaxin would only be administered in “clinical trial mode”, where its recipients would be asked for their consent and proper monitoring for side-effects would follow.
However, this stance towards the vaccine changed a few days later, when it was announced that both vaccine candidates will be treated at par with one another. According to Dr Samiran Panda, a scientist at the ICMR, the circulation of the vaccine essentially implied a single-arm clinical trial, where a placebo wouldn’t be used and results wouldn’t be published under a peer-reviewed journal. Moreover, vaccine recipients would not have the option to choose between Covaxin and Covishield. It was this sudden change of positions that raised concerns.
Consent, Choice and the State
The question about individual choice and consent is critical to the discourse around the inoculation mission. The lack of choice between vaccine candidates has affected turnout rates with only around 56% of eligible individuals getting vaccinated due to concerns among healthcare and frontline workers about the controversy surrounding its fast-paced rollout.
Ethical concerns regarding consent plague the program – should recipients, who aren’t willing participants of a research study, not be allowed to choose between two vaccines that differ in terms of proven efficacy and safety? Given the major difference between the vaccine candidates, how can consent retain its true value when it directly robs an individual of their agency to make personal medical decisions? Most crucially, should the state have the authority to directly or indirectly force the hand of citizens in making informed medical choices?
The decision of the rollout of Covaxin under current conditions seems even more dubious at a time when essential workers are invaluable and at the highest risk of contracting the virus.
Shifting Positions and Unwelcome Surprises
The behaviour of the Indian state and its important bodies in relation to its treatment of Covaxin is also perplexing. The very approval of a vaccine that hasn’t yet completed Phase 3 clinical trials raises alarm. The third phase of trials is critical since it provides for the closest possible model of how a vaccine candidate will behave when administered to a large population.
The vaccine’s intended use has also been disputed. The DCGI had claimed that it would be administered in an open-label clinical trial to ascertain its efficacy against the UK strain of the virus. In direct contradiction, Bharat Biotech managing director Krishna Ella has stated that there was no “confirmatory data” indicating that Covaxin works against it, and has suggested that this form of vaccine circulation was sprung upon him by the government.
The sheer disconnect between the understanding of India’s major regulatory body and the vaccine manufacturer not only is a matter of concern but also sets a worrisome precedent. Moreover, the suggestion that Bharat Biotech was unaware of the government’s expectation of the vaccine’s use can also lead to long-lasting implications for public trust in regulatory bodies and affect state standards for treatment approvals in the future.
Vaccine Diplomacy and Anti-Nationals
The past year has been marked by governmental positions that encourage the idea of India as a major player in the global response against COVID-19. The consequence of the same is the attachment of national pride to India’s vaccine response. Hence, in the face of concerns about the vaccine, critics of the vaccination program have been liberally deemed ‘anti-national’, an all-too-familiar narrative that conveniently sensationalizes every aspect of the matter except its core problems.
Given that Covishield is relatively cheaper than Covaxin, it is important to question the government’s decision to purchase and circulate a vaccine that is yet to produce Phase 3 trial data. Moreover, India has only exported doses of Covishield so far despite having purchased 3.85 million doses of Covaxin, which is peculiar given the government’s otherwise confident domestic narrative around the vaccine. These facts paint a murky picture – one where India seems to be balancing domestic needs and international ambitions, with the former placed in relatively more uncertain territory than the latter.It is necessary to establish that the crux of the concerns surrounding Covaxin pertains to the confusion around its intended usage, authorization prior to completing Phase 3 trials, and the issues of recipient consent and choice. A pandemic is the worst possible time to sow skepticism around medicine. At the same time however, it is important to recognize that the consequences of any missteps in approval or administration of treatments can trigger mass disillusionment from life-saving scientific treatments for years to come. Given as things stand in India, one can only wait and observe what unfolds.
Aarohi Sharma is a Psychology student at Ashoka University. Her academic interests primarily focus on the intersection of politics and psychology in society.
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