Covaxin Phase-3 trial: COVID vaccine volunteer's death due to poisoning, says Bharat Biotech

Covaxin, Bharat Biotech

Bharat Biotech International Limited in a statement issued on January 9 said the probable cause of death of a volunteer during the Phase-III trials of its COVID-19 vaccine in Madhya Pradesh was 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.

A volunteer named Deepak Maravi received the trial vaccine at Bhopal's People's Medical College on December 12, 2020. He was found dead nine days later at his home. The investigation into the cause of death is still going on.

“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.

Meanwhile, Madhya Pradesh Health Minister Prabhuram Choudhary on January 9 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 said as questions were being 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.