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, what they allege are serious violations in the Phase 3 clinical trial being done 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. 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 urged authorities to stop the trial at the Bhopal hospital and to have an independent, transparent and time-bound evaluation of the trial and processes involved in taking consent, the follow-up and medical management when the adverse events arose.
Alleging…