Vaccine maker Bharat Biotech on January 9 said the death of a 45-year-old volunteer in Bhopal during the Phase-III clinical trials of its coronavirus vaccine was not related to the vaccine.
“The volunteer passed away nine days after the dosing and preliminary reviews by the site indicate that the death is unrelated to the study dosing,” the company said in a statement. “We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.”
The post-mortem report issued by Gandhi Medical College in Bhopal showed that the probable cause of death of the volunteer was cardio-respiratory failure as a result of suspected poisoning and the case was under police investigation, the company added.
Covaxin was granted restricted emergency use approval by the DCGI on January 3, 2021. The company is yet to submit the efficacy data.
Trials at People's College of Medical Sciences & Research Centre spark controversy
There were allegations of certain violations in the Phase-III trial taking place at People’s College of Medical Sciences & Research Centre in Bhopal in respect of informed consent, precautions to be taken in enrollment of vulnerable persons, and monitoring of participants.
The Phase III, randomised, double-blind multi-centre study is being sponsored by Bharat Biotech and ICMR.
Four NGOs -- Bhopal Gas Peedit Mahila Stationery Karmchari Sangh, Bhopal Gas Peedit Mahila Purush Sangharsh Morcha, Bhopal Group for Information and Action, and Children Against Dow Carbide written to the government alleging that payments have been made to induce daily wage earners and residents to come forward to be vaccinated.
"Many were not even provided with copies of the consent forms and participant information documents let alone followed up and monitored for adverse reactions. In some cases where individuals experienced adverse reactions that required medical attention, medical services were not provided. There have even been shocking instances of persons receiving doses on the roadside," the NGOs have alleged.
The NGOs say that the People’s Medical College has enrolled more than 1,700 participants in the Phase-III trial, after meeting the initial target of 1,000 participants. The NGOs allege that People’s Medical College actively recruited several hundred individuals from the communities situated behind the abandoned Union Carbide factory, that was responsible for Bhopal Gas Leak, 1984.
Please read here the process followed by pharma companies in enrolling volunteers for clinical trials.
The company's response
Bharat Biotech said it is following all the good clinical practices (GCP) guidelines.
"We would like to reiterate that we conduct our clinical trials in compliance with the study protocol, Good Clinical Practices (GCP) Guidelines as well as with all applicable statutory provisions and the focus at all times is on patient safety. It is this intent on compliance, quality and ethics, that we have enlisted the services of an international contract research organisation to conduct our Phase-III clinical trials," the company said in a statement.
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