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
Bharat Biotech, the Indian pharmaceutical company producing coronavirus vaccine Covaxin, has claimed that the death of a 45-year-old Phase III trials volunteer from Madhya Pradesh's Bhopal was unrelated to the vaccine and is believed to be due to suspected poisoning.
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, reports NDTV.
Deepak Marawi, a daily wage labourer and father of three children, received his first dose on December 12 and died nine days later. His wife alleged the death was "because of the vaccine."
"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)," the report quoted Dr Dixit as saying 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,” Bharat Biotech said in its statement.
“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," the statement added.
"The volunteer passed away nine days after dosing. Preliminary reviews by the site indicate the death is unrelated to the study dosing," the report quoted the statement as saying.
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.