A 45-year-old daily-wage worker, who participated in the Phase 3 trial for Bharat Biotech-ICMR’s Covaxin in Bhopal at the People’s Medical College and Hospital, died December 21, nine days after he got the first jab, according to hospital records.
The postmortem report of 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.”
Bharat Biotech said it couldn’t confirm if Marawi received the vaccine or the placebo since it was a double-blind study. It added that the volunteer, at the time of enrolment, “had fulfilled all the inclusion and exclusion criteria” and was reported to be healthy in all the “site follow up calls post seven days of dosing.”
“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 statement said.
Last week, Covaxin received emergency use approval by the regulators, along with Oxford’s Covishield, although in a controlled “clinical trial” mode. Efficacy data from its Phase 3 trial is pending.
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 Marawi died of “cardiac respiratory failure as a result of suspected poisoning.” The viscera has been sent to the regional forensic laboratory for tests.
Speaking to The Indian Express, Dean of People’s Hospital A K Dixit said that, as per trial rules, Marawi’s death was reported to the Institutional Ethics Committee, Central Drug Controls Standards Organisations and Data Safety Monitoring Board.
The trials at the hospital continue as there was no link found between the death and the proposed vaccine, he said.
“Marawi was given follow-up calls for seven days during which he did not complain of any complications after the first dose was administered to him. All procedures were appropriately followed,” said Dixit.
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.
Meanwhile, the state 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 (Deepak Marawi) were studied and no lapses have come to light.”
Hospital authorities said that all participants received counselling and had given their consent. An audio-video consent of those above 60 years was recorded.
Marawi’s relatives said that he had told only his youngest son that he had participated in a drug trial while the rest of them were unaware and his wife learned about it only after his death.
“My father got to know of the trial from his friends and headed to the hospital with them without informing us,” said his son Suraj. His family said that after his health deteriorated, they urged him to go to the hospital but he refused. It was only on December 21 when he became critical that he was rushed to the hospital where he died.
On Saturday, when The Indian Express visited People’s Hospital, over two dozen people were being administered the second dose of Covaxin. None was aware of Marawi’s death.
One of the volunteers was Pappu Manishkar, 55, a balloon seller, who said he was unaware that the trial was for a Covid vaccine.
“We were told it is like vaccines given to children and since many were coming, even I came in. We were given Rs 750 which is way more than the Rs 200 I make every day,” said Manishkar, a resident of Shankar Nagar.