Death of vaccine volunteer not related to dose: Bharat biotech

Deepak Marawi, 42, took part in the trial on December 12 in Bhopal, said Dr Rajesh Kapur, Vice Chancellor, People’s Medical College and Hospital, a private institute where the trial was conducted. Marawi died on December 21.

Bharat Biotech International Limited on Saturday said that the death of a man who took part in the Phase III trials of Covaxin, one of India’s indigenous coronavirus disease (Covid-19) vaccines, was not related to the dose administered to him.

To test the efficacy of a vaccine, half of the trial participants are given the actual dose while others are administered a placebo with no benefits. (Pratham Gokhale / HT Photo)

Deepak Marawi, 42, took part in the trial on December 12 in Bhopal, said Dr Rajesh Kapur, Vice Chancellor, People’s Medical College and Hospital, a private institute where the trial was conducted. Marawi died on December 21.

“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 adverse events 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,” read the Bharat Biotech statement.

“We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded,” the company said.

To test the efficacy of a vaccine, half of the trial participants are given the actual dose while others are administered a placebo with no benefits.