Bharat Biotech International Limited, in a statement issued on Saturday with regard to reports of a volunteer’s demise during Phase III trials of its Covid-19 vaccine, cited cardio respiratory failure owing to suspected poisoning as the probable cause of death and said the case is under police investigation.
The statement, which referred to the post-mortem report issued by Gandhi Medical College, Bhopal, read: “We would like to state that a volunteer passed away on December 21, 2020, and the death was reported to the People’s College of Medical Sciences & Research Centre by the son of the deceased. The volunteer, at the time of enrolment, had fulfilled all the inclusion and exclusion criteria to be accepted as a participant in the Phase III trial and was reported to be healthy in all the site follow up calls post 7 days of his dosing and no AE’s were observed or reported. 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.”
“We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded,” the statement added.
The Drug Controller General of India (DCGI) recently approved the emergency use of Oxford-AstraZeneca’s Covishield and indigenously developed Covaxin of Bharat Biotech for immunisation against Covid-19 in India. The country will kick off the vaccination drive against Covid-19 on January 16.
In accordance to the provisions of the New Drugs & Clinical Trials Rules, (NDCT rules 2019), the incident was reported by the site team to the Institutional Ethics Committee, the Central Drugs Control Standards Organization (CDSCO) and the Data Safety Monitoring Board (DSMB). Several factors, including the patient’s underlying disease and other pre-existing conditions or any other unrelated occurrence like an accident, can cause such an adverse development during a clinical trial, the statement said. The NDCT rules mandate that all adverse events (AE) and serious adverse events (SAE) be reported, whether related to the trial medication or not, officials said.
“This SAE has been thoroughly investigated and found to be unrelated to vaccine or placebo. All data and reports on this SAE has been submitted to the Site Ethics Committee, CDSCO and DSMB. We are also continuing to cooperate with the investigation requirements from the Madhya Pradesh Police in Bhopal,” the statement said.
Officials expressed their sympathy with the family of the deceased. “However, 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 organization to conduct our phase III clinical trials,” the statement added.
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