Bharat Biotech International Limited issued a statement on Saturday stating that the probable cause of death of the volunteer who passed away during the third phase of its COVID-19 vaccine trial in Madhya Pradesh, last month, was due to cardio-respiratory failure as a result of suspected poisoning.
The company added that the case is under police investigation and the death is not related to the vaccine trial.
Death within days of participating in COVID vaccine trial
The volunteer named Deepak Maravi had received the trial vaccine at Bhopal's People's Medical College on December 12, last year. But according to ANI reports, the person was found dead at his home exactly nine days after getting administered with the trial vaccine.
The investigation into the cause of death is still going on.
#Breaking: Bharat Biotech says 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.— Ayushman Kumar (@Iam_Ayushmann) January 9, 2021
"We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded". pic.twitter.com/FBCuwYHq1b
"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 and 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 adverse events 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," the company said in its statement.
Bharat Biotech also added that it cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.
Postmortem report is still awaited
Madhya Pradesh Health Minister Prabhuram Choudhary earlier today said that the postmortem report is awaited.
"We conduct the vaccine trials only according to the guidelines issued by the Indian Council of Medical Research. A person shows the side effects within 30 minutes after getting the vaccine. Its effect remains visible for the next 24 to 48 hours. However, the volunteer died many days after he was administered the vaccine," he told reporters during a press conference after questions were raised on the safety of the COVID vaccines that have been approved for emergency use.
"It is very unfortunate that the person died, but the initial reports show that his death occurred due to poisoning. The post-mortem report is still awaited. We can say anything only after the final report comes," he added.