New Delhi: Following reports of a volunteer’s demise during its Phase 3 vaccine trials, Bharat Biotech on Saturday cited cardio respiratory failure due to suspected poisoning as the probable cause of death.
The statement they issued also mentioned that the case is under police investigation.
“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,” said the statement, which referred to the post-mortem report issued by Gandhi Medical College, Bhopal.
“We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded,” the statement added.
“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.”
Bharat Biotech’s indigenously developed Covaxin was granted approval for emergency use by Drugs Controller General of India a week ago, along with Oxford-AstraZeneca’s Covishield which is being manufactured at Pune’s Serum Institute of India.
A lot of questions were, however, asked about the Covaxin which many experts said was rushed without adequate results from clinical trials.
The world’s biggest vaccination drive will kick off on January 16.
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