The death of a 45-year-old man in Madhya Pradesh's Bhopal - a volunteer for Phase III trials for Bharat Biotech's coronavirus shot Covaxin - is unrelated to the vaccine and is believed to be due to suspected poisoning, the pharma company said today. Deepak Marawi, a daily wage labourer and father of three children, received his first dose on December 12. He died nine days later, and his wife has alleged it was "because of the vaccine". The police are investigating the charge.
However, Dr Anil Dixit, the Dean of the city's People's Medical College where the trials are underway, said on Friday that the man died due to "other reasons" and not a severe adverse effect.
"It has come to (our) notice that a volunteer - Deepak Marawi - died. However, death was due to other reasons and it was not severe adverse effect (to the vaccine)," Dr Dixit said in a statement.
Bharat Biotech asserted that Deepak Marawi had fulfilled all medical criteria to be part of the trial and had reported healthy during follow-up calls.
"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 after-effects were observed or reported. As per the post-mortem report issued by the Gandhi Medical College, 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," Bharat Biotech said in its statement.
"The volunteer passed away nine days after dosing. Preliminary reviews by the site indicate the death is unrelated to the study dosing," it added.
NDTV has accessed a copy of that report, which also says: "...duration of death couldn't be ascertained as the body is cold... Hence viscera have been preserved for chemical analysis...."
Bhopal Police has opened an investigation and has sought answers from the People's Medical College on seven key points, including details about vaccine dose (and quantity) and a sample.
The police have also asked for a copy of the informed consent form, certified copies of medical check-ups conducted before enrollment in the trial and other documents linked to the clinical trial.
Madhya Pradesh Health Minister Prabhuram Chaudhary has stressed that all vaccine trials in the state take place in accordance with guidelines set down by the centre and the ICMR (Indian Council of Medical Research). He said that any death was "unfortunate" and that Mr Marawi's, in particular, had saddened him.
"My understanding is that after effects of injection show within 30 minutes. If not, then it will show within 24-48 hours of the injection. My information is also that his wife said he was frothing at the mouth when he died. This indicates it is not linked to the vaccine," he told reporters.
Dr Chaudhary also pointed to the results of the post-mortem and added that a team of medical experts would study the death. "We will wait for reports and take action as needed," he said.
Mr Marawi's wife, Vaijanti Marawi, alleged her husband was "fully healthy" till he got the trial dose, and that his condition declined shortly afterwards.
"He got the trial dose on December 12. He was fine for seven days... was eating food. Then he started feeling dizzy. I told him to go to the hospital but he refused. On December 21 he collapsed. He died because of the vaccine. We did not get help from anywhere," she claimed.
She also refused to accept that Mr Marawi could have consumed poison.
"I'm left now with nothing, but to wash utensils in others' houses to feed my children," she said.
Bharat Biotech has also said they cannot confirm if Mr Marawi had, in fact, received a dose of the vaccine since the study was "blinded", which means recipients do not know whether they are being given the vaccine or a place.