The man had participated in the Covaxin trial at a Bhopal hospital on December 12, 2020 and had died on December 21, 2020.
A 42-year-old man from Bhopal died on Saturday due to unknown reasons on December 21.The man had participated in the phase III clinical trial for the Bharat Biotech produced Covaxin vaccine for the coronavirus disease. The doctors who performed the man’s autopsy are yet to zero in on the exact cause of death, but suspect poisoning. His family has, however, alleged that the vaccine was the cause for his death.
A vaccine volunteer identified as Deepak Marawi, had participated in the Covaxin trial held on December 12, 2020 but died on December 21, 2020, nine days after receiving the shot. The death was reported to officials by his son. Bharath biotech in the meantime in a statement to press said, “The probable cause of death was due to cardio respiratory failure as a result of suspected poisoning and a case is under police investigation with the Madhya Pradesh police,”
Dr Rajesh Kapur, Vice Chancellor, People’s Medical College and Hospital where the postmortem trial was conducted told the media that it is unclear if Deepak was administered the vaccine shot or was given a placebo.”It (the vial containing the liquid for trial) comes covered and coded. During the trial, 50 % of people get the actual injection while the rest are given saline,” he said while adding that all protocols were followed and Marawi’s consent was taken before allowing him to participate in the trial.
Bharath Biotech said that preliminary reviews indicate that the death is unrelated to the study. “We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded,” the company said.
The Vice Chancellor said that the exact cause of the death will be known after a viscera test.
The Madhya Pradesh Medico Legal Institute Director Dr Ashok Sharma said the doctor who had performed post mortem on the deceased suspects 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 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.
Rachana Dhingra, a Bhopal-based social activist, claimed neither was Marawi’s consent taken for participation in the clinical trial nor was he given any proof of his participation in the exercise. However, the hospital has denied this charge.
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, said PTI.
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.
1. I’m in Bhopal this week reporting on Bharat Biotech & ICMR’s COVID vaccine trial.
Here’s the family of Deepak Marabi. Marabi died on 21 Dec 2020. His family says it’s from the vaccine, as he took part in the trial in Dec. pic.twitter.com/3LkYLQQftL
— Anoo Bhuyan (@AnooBhu) January 9, 2021
“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.
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.
The pharma company has filed data and reports on the serious adverse events (SAE) to the Site Ethics Committee, CDSCO and the DSMB.
The company said an adverse event during a clinical trial can be caused by the patient’s underlying disease, other pre-existing conditions or any other unrelated occurrence like an accident, “This SAE has been thoroughly investigated and has been found not related to vaccine or placebo. All data and reports on this SAE has been submitted. We are also continuing to cooperate with the investigation requirements from the Madhya Pradesh Police in Bhopal,” read their press release.
Responding to questions from the media Bharath Biotech clarified that it offered Rs 750 per person cash for those participating in the phase III clinical trials in compliance with the Indian Good Clinical Practice (GCP) guidelines. The guidelines seek to protect the rights of human subjects and authenticity of biomedical data generated in all biomedical research in India at all stages of drug development. The reimbursement amount was approved by every Institutional Ethics Committee (IEC) of hospitals where the vaccine shots are given, “It is NOT an inducement.” the company stated.
