Days after participating in vaccine trial, man dies in Bhopal
(Sourced from PTI)
A 42-year-old volunteer named Deepak Marawi, from Bhopal in Madhya Pradesh died nearly ten days after he participated in the clinical trial for COVAXIN held at a private hospital, its vice-chancellor said on Saturday. Dr. Rajesh Kapur, Vice-Chancellor, People's Medical College and Hospital where the trial was conducted said that Marawi had participated in the COVAXIN trial held on December 12, 2020.
Dr. Kapur said that Marawi had volunteered for the trial and was examined. He claimed, "All protocols were followed and Marawi's consent was taken before allowing him to participate in the trial." "It (the vial containing the liquid for trial) comes covered and coded. During the trial, 50 percent of people get the actual injection while the rest are given saline," he said.
Dr. Ashok Sharma, Director of Madhya Pradesh Medico-Legal Institute said that the doctor who had performed postmortem of the deceased suspects that he died of poisoning. "However, the exact cause of the death would be known from his viscera test," he added.
Dr. Kapur said, "After Marawi's death on December 21, we informed the Drugs Controller General of India and Bharat Biotech, which is the producer and sponsor of the trial." The DCGI had last week approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and Bharat Biotech's COVAXIN for restricted emergency use in the country, paving the way for a massive inoculation drive.
Dr. Kapur said Marawi was kept under observation for 30 minutes after the trial as per the guidelines before he was allowed to go. "We monitored his health for seven to eight days," he claimed. Marawi was a tribal and was working as a laborer.
The family members of Marawi said, "When he returned home from the trial he experienced some health problems. He complained of shoulder pain on December 17." "Two days later, he spewed foam. He refused to see a doctor saying he would be alright in a day or two. When his condition deteriorated, he was rushed to the hospital but he died midway," they added.
However, Rachana Dhingra, a Bhopal-based social activist, claimed that neither was Marawi's consent taken for participation in the clinical trial nor was he given any proof of his participation in the exercise. The hospital has denied this charge.