By Our Correspondent
Mumbai, Jan 10:
A 45-year-old daily-wage worker, who participated in the Phase III trial for Bharat Biotech-ICMR’s “Covaxin” at the People’s Medical College and Hospital, in Bhopal (Madhya Pradesh) died on 21 December 2020, nine days after he got the first jab, according to hospital records.
The post mortem report of the deceased Deepak Marawi, a father of three, suspected “poisoning” as a cause. Bharat Biotech, in a statement, said that the “serious adverse reaction” had been “thoroughly investigated” and was found “not related to vaccine or placebo”. A state government panel, too, ruled out any “lapses.”
Marawi, one of the 1750 volunteers in Bhopal, was declared dead when he was brought to Gandhi Medical College and Hospital (Hamidia) by his 24-year-old son Suraj who said his father had bouts of “incessant vomiting and frothing.” The post-mortem stated that he died of “cardiac respiratory failure as a result of suspected poisoning.” The viscera has been sent to the regional forensic laboratory for tests. As per trial rules, Marawi’s death has been reported to the Institutional Ethics Committee, Central Drug Controls Standards Organisations and Data Safety Monitoring Board. The trials at the hospital continue as there has been no link found between the death and the proposed vaccine, the Dean of the hospital said.
The report from the four-member ethics committee, which includes a retired judge, is expected within a month of the incident and another report will take into account the viscera analysis. The MP government’s six-member committee to look into any lapses in the trials has also turned in an all-clear report. The committee, led by Arun Kumar Shrivastav, head of pharmacology department at Gandhi Medical College, said: “The protocols laid down by Bharat Biotech and guidelines of ICMR were duly followed. The documents of the deceased volunteer, Marawi were studied and no lapses have come to light.”
Bharat Biotech International Limited, in a statement issued on Saturday with regard to reports of a volunteer’s demise during Phase III trials of its COVID-19 vaccine, cited cardio respiratory failure owing to suspected poisoning as the probable cause of death and said the case is under police investigation.
The statement, which referred to the post-mortem report issued by Gandhi Medical College, Bhopal, read: “We would like to state that a volunteer passed away on December 21, 2020, and the death was reported to the People’s College of Medical Sciences & Research Centre by the son of the deceased. 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 and was reported to be healthy in all the site follow up calls post 7 days of his dosing and no AE’s were observed or reported. 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 statement added.
In accordance to the provisions of the New Drugs & Clinical Trials Rules, (NDCT rules 2019), the incident 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). Several factors, including the patient’s underlying disease and other pre-existing conditions or any other unrelated occurrence like an accident, can cause such an adverse development during a clinical trial, the statement said. The NDCT rules mandate that all adverse events (AE) and serious adverse events (SAE) be reported, whether related to the trial medication or not, officials said.
“This SAE has been thoroughly investigated and found to be unrelated 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.
