Bharat BioTech said on Saturday that the death of 42-year-old volunteer from Bhopal, who was allegedly administered a dose of its COVID vaccine, Covaxin, in a clinical trial , was "not related” to the vaccine or placebo.
In a statement, the company noted that “with regard to reports of a death in Phase III trials , 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 seven days of his dosing and no AE’s were observed or reported.”
“As per the post-mortem report issued by the Gandhi Medical College, Bhopal that the site received from the Bhopal Police, the probable cause of death was due to cardio respiratory failure as a result of suspected poisoning and the case is under police investigation as well,” said the statement.
It added that 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 said.
The company further said that in accordance with the provisions of the New Drugs & Clinical Trials Rules, (NDCT rules 2019) the serious adverse event 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) in accordance to all the required guidelines.
“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.
Rules mandate that all adverse events (AE) and serious adverse events (SAE) be reported, whether related to the trial medication or not.
“This SAE has been thoroughly investigated and has been found not related to vaccine or placebo. All data and reports on this SAE has been submitted to Site Ethics Committee, CDSCO and DSMB. We are also continuing to cooperate with the investigation requirements from the Madhya Pradesh Police in Bhopal,” the company claimed.
Published - January 09, 2021 09:32 pm IST
