Hyderabad-based Bharat Biotech said on Saturday the death of a 42-year-old volunteer from Bhopal, Madhya Pradesh, who received a dose of Covaxin in the clinical trial was ‘unrelated’ to the vaccine or placebo. The company said the probable cause of death was cardio-respiratory failure due to suspected poisoning.
“According to the autopsy report published by Gandhi Medical College, Bhopal, which the site received from Bhopal Police, the probable cause of death was due to cardio-respiratory failure resulting from suspected poisoning and the matter is under police investigation. too, ”Bharat Biotech said in a statement.
The firm added: “The volunteer died nine days after the dosage and preliminary site examinations indicate the death is unrelated to the study dosage. We cannot confirm whether the volunteer received the study vaccine or a placebo because the study is blind. “
The 42-year-old man died on December 21, 10 days after participating in the clinical trial of Covaxin, held at a private hospital in Bhopal. “Our sympathies go out to the family of the deceased,” the company said.
According to Bharat Biotech, the volunteer, at the time of enrollment, had met all inclusion and exclusion criteria to be accepted as a participant in the Phase III trial and was in good health on all calls. on-site follow-up after seven days of its dosage and no adverse effects were observed or reported.
“There are several factors that can cause an adverse event during a clinical trial, including the patient’s underlying disease, other pre-existing conditions, or any other unrelated event such as an accident.” We also continue to cooperate with Madhya Pradesh investigative requirements. Police in Bhopal ”, added Bharat Biotech.