Days after participating in vaccine trial, man dies in Bhopal
Aditi Tandon
Tribune News Service
New Delhi, January 9
After a participant in phase 3 COVAXIN trials died in Bhopal, Bharat Biotech on Saturday said the mortality was unrelated to the vaccine.
Admitting that a participant in phase 3 trials dies on December 21, 2020, Biotech said the death was reported to the People’s College of Medical Sciences and Research Centre by the son of the deceased.
“The volunteer, at the time of enrolment, had fulfilled all inclusion and exclusion criteria to be accepted as a participant in the Phase III trial and was reported to be healthy in all the site follow up calls post 7 days of his dosing and no adverse events were observed or reported. As per the post-mortem report issued by the Gandhi Medical College, Bhopal that the site received from the Bhopal Police, the probable cause of death was due to cardio respiratory failure as a result of suspected poisoning and the case is under police investigation as well. 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,” the company said.
Deceased Deepak Marabi’s family is alleging COVAXIN trial linkage to the death. Former Madhya Pradesh CM and Congress veteran Digvijay Singh today visited Marabi’s family in Bhopal.
Biotech said in accordance with the provisions of the New Drugs and Clinical Trials Rules, 2019, 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 to all the required guidelines.
“The SAE in the deceased has been thoroughly investigated and has been found not related to vaccine or placebo. All data and reports on this SAE 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,” Biotech said.
