BHOPAL/NEW DELHI: The Bhopal police have begun a probe into the death of a 45-year-old daily wage labourer, days after he participated in Bharat Biotech’s Covid-19 vaccine trial although the post mortem had report said he died of poisoning.
Deepak Marawi, a tribal daily wager, had participated in the trial on December 12 and died nine days later at Bhopal’s People’s College of Medical Sciences and Research Centre. After registering a case under Section 174 CrPc, the police have sought information about the vaccine company, the dosage administered to Marawi, a certified copy of his formal consent and other related documents, besides certified copies of the reports of clinical investigations carried out to medically check the man before the vaccination.
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Marawi’s autopsy report had mentioned “death due to cardio respiratory failure as a result of suspected poisoning” but the family of the daily wager alleged that no proper medical investigation was carried out.
Bharat Biotech said in a statement 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 seven days of his dosing and no adverse events were observed or reported.
“This SAE (serious adverse event) has been thoroughly investigated and has been found not related to vaccine or placebo,” the company said, adding that it cannot confirm if the volunteer received the study vaccine or a placebo as the study is blind-sided. “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,” said the firm, stressing that its clinical trials were in compliance with the study protocol, good clinical practices guidelines as well as with all applicable statutory provisions and the focus at all times is on patient safety.
But experts expressed concern at opacity in the case. “Every serious adverse event requires proper investigation, involving the investigator, sponsor, site ethics committee and the regulator. Given the virus and vaccines, we need extra caution with regards to SAEs in vaccine trials,” said public health expert Anant Bhan. Neither Raghevendra Gumashta, who is the principal investigator of the trial at the medical college, nor V G Somani, the Drug Controller General of India, was available for comment despite multiple attempts to reach them.