Days after participating in vaccine trial, man dies in Bhopal

A 42-year-old man, who had takenpart in the trial of indigenous coronavirus vaccine Covaxinhere on December 12, died nine days later, with doctorssuspecting that poisoning could be the cause.The vaccine maker Bharat Biotech said in a statementthat preliminary reviews indicated that the death wasunrelated to Covaxin.Dr Rajesh Kapur, Vice Chancellor, Peoples MedicalCollege and Hospital, a private institute where the trial wasconducted, said Deepak Marawi, the deceased, had taken part inthe Covaxin trial on December 12.

A 42-year-old man, who had takenpart in the trial of indigenous coronavirus vaccine Covaxinhere on December 12, died nine days later, with doctorssuspecting that poisoning could be the cause.

The vaccine maker Bharat Biotech said in a statementthat preliminary reviews indicated that the death wasunrelated to Covaxin.

Dr Rajesh Kapur, Vice Chancellor, People's MedicalCollege and Hospital, a private institute where the trial wasconducted, said Deepak Marawi, the deceased, had taken part inthe Covaxin trial on December 12. He died on December 21.

Madhya Pradesh Medico Legal Institute Director DrAshok Sharma said the doctor who performed autopsy suspectedthat Marawi died of poisoning. However, the exact cause ofdeath would be known from his viscera test, he added.

Bharat Biotech said in a statement that Marawi hadfulfilled ''all the inclusion and exclusion criteria to beaccepted as a participant in the Phase III trial''.

He was reported to be healthy in follow-up calls postseven days of his dosing and no adverse reaction was observedor reported, the Hyderabad-based company said.

''The volunteer passed away nine days after the dosingand preliminary reviews indicate that the death is unrelatedto the study dosing. We cannot confirm if the volunteerreceived the study vaccine or a placebo as the study isblinded,'' it added.

Dr Kapur said that after Marawi's death, the DrugController General of India and Bharat Biotech were dulyinformed.

He said Marawi, a tribal labourer, had volunteered forthe trial and was examined.

''All protocols were followed and Marawi's consent wastaken before allowing him to participate,'' he claimed.

Dr Kapur also said he cannot confirm whether Marawiwas administered the vaccine shot or a placebo.

''It (the vaccine vial) comes covered and coded. Duringthe trial, 50 per cent people get the actual injection whilethe rest are given saline,'' he said.

Kapur said Marawi was kept under observation for 30minutes after the trial as per guidelines before he wasallowed to go. ''We monitored his health for 7 to 8 days,'' headded.

Family members of Marawi claimed that when he returnedhome, he felt uneasy and experienced some health problems.

''He complained of shoulder pain on December 17. Twodays later, he frothed at mouth. He refused to see a doctorsaying he would be alright in a day or two. When hiscondition deteriorated, he was being rushed to hospital whenhe died midway (on December 21),'' they added.

The Drugs Controller General of India last weekapproved Oxford COVID-19 vaccine Covishield, manufacturedby Serum Institute, and Covaxin of Bharat Biotech forrestricted emergency use in the country, paving the way for amassive inoculation drive. PTI LAL NSK KRKKRK KRK