Bhopal volunteer's death unrelated to Covaxin, says Bharat Biotech

'We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded,' says Bharat Biotech

Bharat Biotech International Limited, maker of Covaxin, said that the Bhopal-based volunteer of Phase-3 trials passed away nine days after the dose and “preliminary reviews indicate that the death is unrelated to the study dosing.”

Deepak Marawi, a 42-year-old daily wage laborer, was administered the first dose of Covaxin on December 12 at the trial site – People's College of Medical Sciences & Research Centre, a private medical facility in Bhopal. Marawi's death on December 21 was reported to the centre by his son. However, the incident came to light on Saturday.

“As per the post-mortem report issued by the Gandhi Medical College, Bhopal, the probable cause of death was due to cardio respiratory failure as a result of suspected poisoning,” Bharat Biotech said in a statement.

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“We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded," the statement added.

The clinical trials of Covaxin, co-developed by Bharat Biotech and Indian Council of Medical Research-National Institute of Virology are, as stated by the company earlier, “randomised, double-blind, placebo-controlled.”

Double blind denotes a trial process where the dose content (test vaccine or placebo) is revealed neither to the subject/volunteer nor the administrator.

Marawi is among the 25,800 volunteers across the country who have received at least one dose of Covaxin undergoing Phase-3 trials. Covaxin is administered in a two dose schedule, 28 days apart.

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“The volunteer, at the time of enrolment, had fulfilled all the inclusion-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 seven days of his dosing. No adverse events were observed or reported then,” the Hyderabad based bio-tech firm said.

Bharat Biotech sources told DH that the Bhopal death was the only Serious Adverse Event (SAE) encountered till now during the Phase-3 trials, which is being conducted at 26 medical sites in the country.

“But, following the New Drugs & Clinical Trials Rules 2019 that mandate that all adverse events be reported, whether related to the trial medication or not, the SAE 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)” BBIL said.

“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,” BBIL officials said, assuring to continue to cooperate with the Madhya Pradesh Police investigation in the case.

Covaxin was accorded an emergency use authorisation last Sunday by the central drug regulator, along with Covishield developed by Oxford University-AstraZeneca, and manufactured by the Serum Institute of India, Pune.