As the country prepares to roll out two Covid-19 vaccines on a mass scale, a clutch of organisations from Bhopal have written to the Prime Minister and Health Minister on allegations of serious violations in the Phase-3 clinical trials being conducted at the People’s College of Medical Sciences & Research Centre in Bhopal to assess the safety, immunogenicity and efficacy of Covaxin.

Covaxin is the Covid-19 vaccine from Bharat Biotech being developed in collaboration with the Indian Council of Medical Research (ICMR). It was recently approved for restricted use, (along with Serum Institute of India’s vaccine), but in a clinical trial mode - a caveat that had many scientific voices raising concerns on its implications.

Push to stop trials

The letter urged authorities to stop the trial at the Bhopal hospital and to have an independent, transparent and time-bound evaluation of the trial and process involved in taking consent, the follow-up and medical management when the adverse events arose.

Alleging that people from communities affected by Bhopal’s Union Carbide gas disaster, were among those recruited on the trial, the letter said, “Some of these individuals have faced adverse events since dosing in the trial, and even a death has taken place. ….Evidence has emerged that the trial in Bhopal is being conducted in gross violation of laws and guidelines governing clinical trials in India.” The letter  was signed by multiple groups including the Bhopal Group for Information and Action.

Rachna Dhingra from the group told BusinessLine that they had raised concerns on the trial for over a week now and no one has contacted them yet from the government, the company or the contract research organisation IQVIA.

While the hospital has denied wrong-doing, IQVIA had earlier told BusinessLine that Good Clinical Practice norms had been followed and the regulators were kept informed.

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