The vaccine maker said that the volunteer, at the time of enrolment, had fulfilled all the inclusion and exclusion criteria to be accepted as a participant in the Phase III trial. He was reported to be healthy in all the site follow up calls post 7 days of his dosing and no adverse effects 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 company said.
According to the company’s official statement, the volunteer passed away nine days after the dosing and preliminary reviews by the site indicated that the death was unrelated to the study dosing. “We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded,” it said.
Bharat Biotech said that in accordance with the provisions of the New Drugs & Clinical Trials Rules, (NDCT rules 2019), 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 to all the required guidelines.
“There are several factors that can cause an adverse event during a clinical trial, including the patient’s underlying disease, other pre-existing conditions or any other unrelated occurrence like an accident. The NDCT rules mandate that all adverse events (AE) and serious adverse events (SAE) be reported, whether related to the trial medication or not. 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 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 said.