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The Quint has found that that the same Bhopal hospital that had earlier been reported as having committed ethical breaches during COVID-19 vaccine trials has also violated the protocols set down by Bharat Biotech for phase 3 trials of its Covaxin candidate vaccine.
In addition to already reported violations of the New Drug and Clinical Trial Rules 2019 (NDCT 2019), the People’s Hospital also violated these protocols to a degree that renders data from this section of trials “untrustworthy,” notes Pulla.
The hospital is one among 26 trial sites for Covaxin and had signed on more than 1,700 participants. The protocol violation also jeopardises Bharat Biotech’s understanding of the efficacy and safety of its COVID-19 vaccine.
Bhopal gas tragedy victims were used as guinea pigs for COVID vaccine trials
Print edition : February 12, 2021
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Outside a designated centre for vaccine trials in Bhopal on January 8. The Phase 3 trial for Covaxin is going on. The lack of efficacy data has led to a trust deficit among the public. Photo: GAGAN NAYAR/AFP
Bhopal gas tragedy victims were used as guinea pigs for COVID vaccine trials in total violation of ethical and medical norms.
In early December last year, as the world battled the novel coronavirus, a van arrived at Garib Nagar, a slum in Bhopal, Madhya Pradesh, loudspeakers attached to it blaring an announcement: Come and get vaccinated for COVID. And get Rs.750 in exchange. For the survivors of the Union Carbide gas leak of 1984 who lived there, some of who could not even afford a rickshaw ride to the hospital, it seemed like an amazing offer. For 57-year-old Mohan Sahu, whose daily income from selling peanuts on a handcart is Rs.250, it was an opportuni
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The year 2021 in India began with a flurry of events around the Covid-19 vaccine. The Indian government conducted dry runs for the vaccines, and two vaccines Covishield (Oxford University-AstraZeneca) and Covaxin (Bharat Biotech) were granted
accelerated regulatory approval by the Central Drugs Standard Control Organisation (CDSCO). The process of granting these vaccines regulatory approval has been a subject of intense scrutiny. The grant of these approvals and the scrutiny involved in the process has been marred with several concerns as these vaccines are yet to complete Phase III clinical trials.
In this blog, we examine the regulatory underpinnings of the approvals granted to Covishield and Covaxin, and attempt to shed light on the existing legal framework dealing with the approval of drugs for emergency use.