As the country preps 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 what they allege are “serious violations” in the Phase 3 clinical trial being done at the People’s College of Medical Sciences & Research Centre (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. It was recently given restricted use approvals, (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.
The letter has urged authorities to stop the trial at the said hospital and have an independent, transparent and time-bound evaluation of the trial and processes involved in taking consent, the follow-up and medical management when some volunteers had reactions etc.
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 on behalf of the volunteers was undersigned by multiple groups, including the Bhopal Group for Information and Action.
Rachna Dhingra from the Group told BusinessLine they had raised concerns on the trial for over a week now and no one has contacted them yet from the Government, company or the contract research organisation IQVIA.
While the hospital has denied wrong-doing, IQVIA had earlier told the correspondent that Good Clinical Practice norms had been followed in the Covaxin trial and regulators were kept abreast of details. Bharat Biotech, too, said on the incident that it had adhered to the governing rules.