Pharmaceutical company Bharat Biotech on Saturday said that the death of a 45-year-old volunteer in Bhopal during the clinical trials of i...
Pharmaceutical company Bharat Biotech on Saturday said that the death of a 45-year-old volunteer in Bhopal during the clinical trials of its coronavirus vaccine was not related to the jab, reported The Hindu.
“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.”
It said that according to the autopsy reported by Bhopal’s Gandhi Medical College, the volunteer died due to cardio-respiratory failure, resulting from a suspected case of poisoning. The case is under police investigation, the statement said.
“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 occurrence like an accident,” Bharat BioTech said.
The company said that the volunteer had fulfilled all the criteria to be accepted as a participant in the trial and was reported to be healthy with no adverse event noted seven days after his dosing. An adverse event is any untoward medical occurrence in patients when they are administered a pharmaceutical product and which does not necessarily have...
