Bhopal:
A42-year-old man who had takenpart in the trial of Covaxin, the indigenous coronavirusvaccine developed by Bharat Biotech, died nine days later inBhopal, officials said.
While doctors suspect that poisoning could be thecause, Bharat Biotech said in a statement that ''preliminaryreviews'' indicate that the death was unrelated to the vaccinetrial.
Dr Rajesh Kapur, Vice Chancellor, People's MedicalCollege and Hospital where the trial was conducted, told PTI that Deepak Marawi, the deceased, had participated in theCovaxin tria on December 12. He died nine days later.
Bharat Biotech said in a statement that Marawi hadfulfilled ''all the inclusion and exclusion criteria to be accepted 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 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 studyis blinded,'' it added.
Madhya Pradesh Medico Legal Institute Director DrAshok Sharma said the doctor who performed autopsy suspected that he died of poisoning. However, the exact cause of the death would be known from his viscera test, he added.
''After Marawi's death on December 21, we informed theDrug Controller General of India and Bharat Biotech, which isthe producer and sponsor of the trial,'' Dr Kapur said.
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 too said he cannot confirm whether Marawi wasadministered the vaccine shot or was given 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 a 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 but hedied midway (on December 21),'' they added.
Rachana Dhingra, a Bhopal-based social activist,claimed neither Marawi's consent was taken for participationin the clinical trial nor he was given any proof of hisparticipation in the exercise.
However, the hospital has denied this charge.
The Drugs Controller General of India (DCGI) lastweek approved Oxford COVID-19 vaccine Covishield, manufacturedby the Serum Institute, and indigenously developed Covaxin ofBharat Biotech for restricted emergency use in the country,paving the way for a massive inoculation drive.