As informed by Bharat Biotech, the 42-year-old man had died on December 21, 2020 - 10 days after he participated in the clinical trial for Covaxin held at a private hospital in Bhopal.
The volunteer is stated to have fulfilled all the inclusion and exclusion criteria to be accepted as a participant in the Phase III trial at the time and was reported to be in good health in all the site follow up calls after seven days of his dosing. At that point, no adverse events were observed.
To settle any alarm raised by the occurrence, the Hyderabad-based company clarified on Saturday that the death is unrelated to 'Covaxin' and the probable cause is a cardio-respiratory failure because of suspected poisoning.
"As per the post-mortem report issued by the Gandhi Medical College, Bhopal, that the site received from the Bhopal Police, the probable cause of death was due to cardiorespiratory failure as a result of suspected poisoning and the case is under police investigation as well," Bharat Biotech's statement read.
It added, "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. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded".
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"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. We are also continuing to cooperate with the investigation requirements from the Madhya Pradesh Police in Bhopal," Bharat Biotech wrote.
Bharat Biotech's Covaxin is among the two vaccines approved by the Drugs Controller General of India (DCGI) for restricted emergency use in the country. It is indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The DCGI approval is being scrutinised as a section of experts and opposition leaders questioned why has the vaccine been authorised when the efficacy is yet to be published as it undergoes the third phase of clinical trial. The average efficacy in the case of its Indian trials is not yet known to the public.
Meanwhile, India is set to begin its vaccination drive from January 16 wherein healthcare workers and the frontline workers, estimated to be around 3 crores are going to be the first priority.
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