New Delhi, January 9: Hours after a 42-year-old volunteer in the trials of COVID-19 vaccine developed by Bharat Biotech died in Bhopal, the drug maker on Saturday affirmed that his death was not related to Covaxin's trials. "As per post-mortem report by Gandhi Medical College, 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," said Bharat Biotech. COVID-19 Vaccine Latest Update: Covishield and Covaxin Get Approval by DCGI for Emergency Use in India.
The vaccine developer said that the volunteer was reported to be healthy in a follow-up after seven days of receiving Covaxin's shot and no side effects were seen. " The volunteer, at time of enrollment, had fulfilled all criteria to be accepted as participant in Phase III trial & was reported to be healthy in all site follow up calls post 7 days of dosing & no after-effects were observed, reported," said Bharat Biotech. Bharat Biotech COVID-19 Vaccine: 42-Year-Old Volunteer Dies 10 Days After Participating in Covaxin Trials in Bhopal.
"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," it added.
Covaxin, the COVID-19 vaccine developed by Bharat Biotech in collaboration with ICMR, was approved by the DGCI for emergency use on January 3. The vaccine is in its phase three trials. It's phase 1 and 2 trials have been largely successful.