India’s Vaccine Approval, Without Transparency on Clinical Trial Results, Is Eroding Public Trust
India’s drug regulatory authority formally approved two Covid19 vaccines for emergency use on Sunday — one locally manufactured by the Serum Institute of India, which is a version of the Oxford-AstraZeneca vaccine gaining regulatory approval around the world, and the other developed by local firm Bharat Biotech, called Covaxin, in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Since the approval announcement for both became public, it’s Bharat Biotech’s Covaxin that has raised concerns among experts and journalists.
While the Drugs Controller General of India (DCGI) announced it had found both vaccines safe to use, experts are questioning the validity of data provided by Bharat Biotech. Phase I and II trials for its Covaxin show positive results, but Bharat Biotech is still in the midst of conducting its Phase III trials (large-scale controlled trials that determine the vaccine’s efficacy over a diverse group of people) and hasn’t provided conclusive results from the final phase.
The approval, granted with Phase III results still pending, has raised transparency concerns among the medical community in India. As infectious diseases researcher Dr. Swapneil Parikh told the BBC, “I understand there is a need to go through the process quickly, remove regulatory hurdles. … However… [governments and regulators] have a duty to be transparent about the data they have reviewed and the process involved in making the decision to authorize a vaccine because if they don’t do this, it can affect the public’s faith in the process.”
It’s the public’s faith in the country’s health care institutions — or lack thereof — that is in stark display. Formal government approval for a vaccine — backed both by the country’s drugs authority and by the vaccine’s manufacturer — should be good news, but since the announcement, the news has been mired in suspicion. It’s because of a lack of transparency, aided by politics informing the government’s Covid19 response, that has plagued the pandemic in India. This, in turn, has led to an utter lack of trust the public harbors in institutions, particularly those of health care.
Since the beginning of the pandemic, publicizing data from ICMR has been contingent upon approvals from the government. It went as far as asking the Supreme Court to bar the media from publishing Covid19 news without first “ascertaining the facts from the mechanism provided by the government.” Throughout the pandemic, we’ve seen the administration try to suppress the severity of the crisis, and later try to fast-track Covaxin, to experts’ incredulity. Now, a similar grandstanding seems to be at play here, with PM Modi congratulating India’s innovators, and calling the decision to approve the two vaccines “a decisive turning point to strengthen a spirited fight.” The main issue is that this grandstanding seems hollow when the same leaders are obstructing any way of checking if their claims are true, or of corroborating the efficacy of vaccines they confidently flaunt as successes. The conclusive proof, unfortunately, isn’t available to the public.
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From misleading endorsements of hydroxychloroquine as prophylaxis to baseless support of Ayurvedic ‘immunity-boosting’ supplements, Indian institutions, such as the ICMR, haven’t encouraged trust in their handling of the pandemic, providing little to no transparency around decisions and a disregard for scientific evidence in recommendations to the public. The current approval of Bharat Biotech’s Covaxin was announced in a statement, with no opportunity for experts, journalists, or the general public to ask questions — a practice consistent with the current government’s pattern of public engagement (or lack thereof).
From how the government reported coronavirus numbers to what treatments it encouraged to how it approves vaccines, the common thread among all of these is a lack of open debate and communication. This has understandably culminated in the public’s inability to take any institutional guidance seriously, especially when looking at how politics has played a major role thus far in government institutions’ motivations to quicken solutions to the pandemic.
To be sure, the goal is to emerge successfully out of the pandemic, with an effective, reliable, and affordable vaccine, and a vaccine distribution plan, in place. In order for us to get there, and for the country to rally around immunization in a collective manner, transparency is key. For it’s only transparency that can build trust — but for now, both seem to be dangerously missing from the way forward charted by the government.