After the demise of a volunteer from Bhopal, who took Covaxin dose during the clinical trial, Bharat Biotech on Saturday said the death is not related to Covid19 vaccine or placebo.
According to a media report, the 42-year-old volunteer from Bhopal in Madhya Pradesh, who has been identified as Deepak Marawi, participated in the Covaxin trial on December 12.
The volunteer died 9 days later after taking the dose.
The trial was conducted at People’s Medical College and Hospital.
“The volunteer, at the time of enrolment, had fulfilled all criteria to be accepted as participant in Phase III trial and was reported to be healthy in all site follow up calls post seven days of dosing and no after-effects were observed/reported,” Hyderabad-based Bharat Biotech said in a statement.
The company said, “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,” it added.
According to the post-mortem report of Gandhi Medical College, Bhopal, which was available on the site of Bhopal Police, the probable cause of death was due to cardio-respiratory failure as a result of suspected poisoning.
The company said the cause of the volunteer is under the investigation of police.
The report quoted Madhya Pradesh Medico Legal Institute director Dr Ashok Sharma as saying that the doctor, who performed autopsy, suspected the cause of the death as poisoning.
However, the exact cause of the death would be known from his viscera test, DR Sharma said.
Covaxin has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology.
The indigenous Covid19 vaccine has been granted emergency use authorisation in ‘clinical trial mode’ by the Indian government recently.
Meanwhile, the Centre on Saturday said the much-awaited COVID19 vaccination drive across India will begin on January 16.
The announcement came after Prime Minister Narendra Modi chaired a high-level meeting to review the Covid19 situation and preparedness for vaccination in the country.