Bhopal: After a 42-year-old man from Madhya Pradesh’s Bhopal who enrolled as a volunteer for clinical trials of Bharat Biotech’s Covaxin died nine days later on Saturday, the company issued a statement. Also Read - Bharat Biotech to Begin Phase-1 Trials of Intranasal COVID-19 Vaccine in Feb-March
Bharat Biotech said the volunteer at time of enrolment had fulfilled all criteria to be accepted as participant in Phase III trial and was reported to be healthy in all site follow up calls post seven days of dosing and no after-effects were observed or reported. Also Read - Bharat Biotech Announces Completion of Volunteer Enrollment For Phase-3 Clinical Trials of Covaxin
As per post-mortem report by Gandhi Medical College in Bhopal that the site received from Bhopal Police, the probable cause of death was due to cardiorespiratory failure as a result of suspected poisoning and the case is under police investigation as well, Bharat Biotech said in the statement. Also Read - Have Made 16 Vaccines, Don't Accuse us of Inexperience: Bharat Biotech Hits Back at Critics Questioning Covaxin Efficacy
The company further said, “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. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.”
Earlier on Saturday, a government official suspected poisoning in the man’s death but added that the exact cause of the death will be known after viscera test.
Dr Rajesh Kapur, Vice Chancellor, People’s Medical College and Hospital where the trial was conducted, said that Deepak Marawi had participated in the Covaxin trial held on December 12, 2020.
Madhya Pradesh Medico Legal Institute Director Dr Ashok Sharma said the doctor who had performed postmortem of the deceased suspected 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 the Drug Controller General of India and Bharat Biotech, which is the producer and sponsor of the trial,” Dr Kapur said.
He said Marawi had volunteered for the trial and was examined.
“All protocols were followed and Marawi’s consent was taken before allowing him to participate in the trial,” he claimed.
Dr Kapur, however, said he cannot confirm whether Marawi was administered the vaccine shot or was given a placebo.
“It (the vial containing the liquid for trial) comescovered and coded. During the trial, 50 per cent people get the actual injection while the rest are given saline,” he said.
Kapur said Marawi was kept under observation for 30 minutes after the trial as per guidelines before he was allowed to go.
“We monitored his health for 7 to 8 days,” he claimed.
Madhya Pradesh Health Minister Dr Prabhuram Choudhary did not respond to phone calls.
Meanwhile, family members of Marawi, a tribal, said he was working as a labourer.
They claimed that Marawi and his colleague were administered the Covaxin injection on December 12 during the trial.
“When he returned home he felt uneasy and experienced some health problems. He complained of a 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 being rushed to hospital but he died midway (on December 21),” they added.
Rachana Dhingra, a Bhopal-based social activist, claimed neither Marawi’s consent was taken for participation in the clinical trial nor he was given any proof of his participation in the exercise.
However, the hospital has denied this charge.
The Drugs Controller General of India (DCGI) had last week approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
(With inputs from PTI)