Covaxin Trial Volunteer May Have Died of Poisoning: Bharat Biotech
A 42-year-old volunteer from Bhopal died nine days after he participated in the clinical trials for Covaxin.
Bharat Biotech International limited issued a statement on Saturday, 9 January, stating that as per the post mortem report by Gandhi Medical College, Bhopal, the probable cause of death of a volunteer enrolled in trials for the Covaxin vaccine, was due to cardiorespiratory failure as a result of suspected poisoning. The case is under police investigation as well, ANI reported, citing the Hyderabad-based pharma company’s statement.
42-year-old Deepak Marawi died nine days after he participated in the Phase III clinical trial for Covaxin held at People's Medical College and Hospital, its vice chancellor, Dr Rajesh Kapur, said on Saturday. The trials were held on 12 December 2020.
Bharat Biotech, in its statement, also said that it cannot confirm if the volunteer received the study vaccine or a placebo, as the study is blinded.
According to the vaccine manufacturing company, the volunteer, at the 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 after seven days of the dosage, ANI reported. No after-effects were observed/reported, Bharat Biotech said.
According to an Indian Express report, the serious adverse event was reported by the site team to the Institutional Ethics Committee, the Central Drugs Control Standards Organization (CDSCO) and the Data Safety Monitoring Board (DSMB), in accordance with the provisions of the New Drugs & Clinical Trials Rules (NDCT rules 2019).
This adverse event has been thoroughly investigated and has been found to be not related to vaccine or placebo, the statement said. “All data and reports on this has been submitted to the Site Ethics Committee, CDSCO and DSMB. We are also continuing to cooperate with the investigation requirements from the Madhya Pradesh Police in Bhopal,” the statement added according to the Express report.
The officials expressed their sympathy with the family of the deceased. “However, we would like to reiterate that we conduct our clinical trials in compliance with the study protocol, Good Clinical Practices (GCP) guidelines, as well as with all applicable statutory provisions, and the focus at all times is on patient safety,” the statement further added.
Survivor Organisations Appeal to PM Modi
Soon after the incident, organisations of survivors of the Union Carbide gas disaster in Bhopal at a virtual press conference on Sunday, made an appeal to Prime Minister Narendra Modi to immediately stop the ongoing clinical trial of the vaccine in Bhopal.
In a letter to the prime minister and the union health minister, they have sought punishment for all parties who showed negligence in ensuring the well-being and safety of the trial participants.
On behalf of Bhopal survivors' organisations, Rashida Bee, president of the Bhopal Gas Peedit Mahila Stationery Karmchari Sangh and a recipient of the Goldman Environmental Prize, demanded Rs 50 lakh for the family of the gas victim who died during the Covaxin trial. She said that monetary compensation should be paid for damages caused in this case, in the same way it is done in case of deceased ‘Corona warriors’.
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