Bhopal organisations ask govt to stop Bharat Biotech COVID-19 vaccine trials; cite norms violation at site

Four organisations representing survivors of the Union Carbide gas disaster in Bhopal have written to Prime Minister Narendra Modi and Health Minister Dr Harsh Vardhan to immediately stop the ongoing clinical trials of Bharat Biotech's COVID-19 vaccine Covaxin in Bhopal.

The letter alleged irregularities and ethical violations in the conduct of the clinical trial of Covaxin by the People's College of Medical Sciences & Research Centre, Bhopal. The hospital is one of the sites where Phase III clinical trials of the vaccine are currently underway. 

According to the organisations, many people from communities affected by the Union Carbide gas disaster in Bhopal and by contaminated water were recruited into the trial in violation of ethical procedures established under the law. Some of these individuals have faced adverse events since the dosage, and even a death has taken place, they alleged. 

"In early December, People's Hospital, a private medical college & hospital, sent vehicles into communities situated behind the abandoned Union Carbide factory -Gareeb Nagar, Shankar Nagar, Oriya Basta, Kainchi Chhola, JP Nagar and others - and announced that COVID-19 vaccine injections were available and everyone would be paid Rs 750 as well for getting each vaccination shot. The amount of Rs 750 meant to be reimbursement of travel expenses and loss of daily wages to trial participants is in fact a substantial sum for such poor communities and appears to have been used as an inducement to make people come forward. These vehicles were accompanied by staff of the hospital who recruited several hundred residents of these communities. In other cases, daily wage labourers were recruited from their peetha (gathering for daily wage labourers) for the trial," the letter said.

The organisations allege that several of the trial participants were not told that they were being recruited for a trial but were under the belief that they were getting the vaccination to protect them from COVID-19. The letter states that the Hindi participant information sheet and consent form contains technical language that is beyond the comprehension of any layperson, let alone persons with minimal education. Further, they allege that in complete violation of statutory provisions, audio visual recordings of the informed consent process were not made. "The Participant Information Sheet and Informed Consent Form being used in the clinical trial contains a consent form for audio-visual recording. However, despite being included in the participant information document and consent form and being legally mandated, the same was not employed in the informed consent process," the letter said.

The organisations have asked the government to immediately stop the clinical trial for Covaxin at People's College of Medical Sciences & Research,and sought the setting up of an independent body to conduct an impartial, transparent, thorough, and time-bound investigation to ascertain violations of ethics, protocols and legal requirements pertaining to conduct of the clinical trial. They also wanted the findings of the enquiry to be put in public domain. 

Stating that the principal investigator and the co-investigators of the clinical trial at the site have failed to adhere to the scientific and ethics standards, legal requirements, and have been insensitive and negligent in ensuring safety, well being and the rights of the participants of the trial, the organisations wanted all the responsible parties found to be negligent of their duties to be suspended from all research in addition to making them accountable for the violations and negligence. It wanted the registration of the People's College Institution Ethics Committee to be suspended and an audit and inspection of its functioning to be conducted by the drug regulatory authority. The organisations also sought details of the process and timelines through which the death of the trial participant is being investigated by the various parties - the PI, Ethics Committee, DSMB, and DCGI - and the findings when the final determination has been completed.

The letter has been signed by representatives of Bhopal Gas Peedit Mahila Stationery Karmchari Sangh, Bhopal Gas Peedit Mahila Purush Sangharsh Morcha, Bhopal Group for Information and Action, Children Against Dow Carbide.

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