BackDeath of volunteer who took dose of Covaxin 'not related' to vaccine or placebo, says Bharat Biotech
The company says that at the time of enrolment, the 42-year-old volunteer in Bhopal had fulfilled all criteria to be accepted as participant in Phase III trialThe volunteer was reported to be healthy in all site follow up calls post seven days of dosing and no after-effects were observed/reported, says the firm
PremiumNew Delhi: Hyderabad-based Bharat Biotech on Saturday said that the death of a 42-year-old volunteer from Bhopal in Madhya Pradesh who took a dose of ovaxin in the clinical trial of the Covid-19 vaccine was "not related" to the vaccine or placebo.
"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," sid Bharat Biotech in a statement.
"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," the company added.
As per post-mortem report by Gandhi Medical College, Bhopal that the site received from 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, said the company.
Dr Rajesh Kapur, Vice Chancellor, People's Medical College and Hospital where the trial was conducted, told PTI that Deepak Marawi, the deceased, had participated in the Covaxin tria on December 12,reported PTI. He died nine days later.
Madhya Pradesh Medico Legal Institute Director Dr Ashok Sharma said the doctor who performed autopsy suspected that he died of poisoning. However, the exact cause of the death would be known from his viscera test, he added.
"After Marawi's death on December 21, we informed the Drug Controller General of India and Bharat Biotech, which is the producer and sponsor of the trial," Dr Kapur said.
He said Marawi, a tribal labourer, had volunteered for the trial and was examined.
"All protocols were followed and Marawi's consent was taken before allowing him to participate," he claimed.
Dr Kapur too said he cannot confirm whether Marawi was administered the vaccine shot or was given a placebo.
"It (the vaccine vial) comes covered and coded. During the trial, 50 per cent people get the actual injection while the rest are given saline," he said.
Kapur said Marawi was kept under observation for 30 minutes after the trial as per guidelines before he was allowed to go. "We monitored his health for 7 to 8 days," he added.
Family members of Marawi claimed that when he returned home, he felt uneasy and experienced some health problems.
"He complained of a shoulder pain on December 17. Two days later, he frothed at mouth. He refused to see a doctor saying he would be alright in a day or two. When his condition deteriorated, he was being rushed to hospital but he died midway (on December 21)," they added.
Rachana Dhingra, a Bhopal-based social activist, claimed neither Marawi's consent was taken for participation in the clinical trial nor he was given any proof of his participation in the exercise.
However, the hospital has denied this charge.
he Drugs Controller General of India (DCGI) last week approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
Developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology, the indigenous vaccine was granted emergency use authorisation in ‘clinical trial mode’ by the Indian government this week.
It is an “inactivated" vaccine developed by chemically treating novel coronavirus samples to make them incapable of reproduction. This process leaves the viral proteins, including the spike protein of the coronavirus which it uses to enter the human cells, intact.
Given as two doses, three weeks apart, the viral proteins in the vaccine activate the immune system and prepare people for future infections with the actual infectious virus. According to Bharat Biotech, the therapeutic can be stored at room temperature for at least a week.
A study on the Phase 1/2 trial published in the preprint server medRxiv in December showed the therapeutic doesn't cause any serious side effects. However, there has been no further data released in the public domain which could demonstrate that the vaccine is safe and effective.
"ICMR-Bharat Biotech vaccine is a killed whole-virus vaccine and there are absolutely no data available so far on its protective efficacy. I am critical of its getting approval by the authorities," immunologist Vineeta Bal, affiliated with the National Institute of Immunology in New Delhi, told PTI.
Meanwhile, it has been announced on Saturday that India will launch its COVID-19 vaccination drive from January 16 in what Prime Minister Narendra Modi has called the world's largest inoculation programme with priority to be given to nearly three crore healthcare and frontline workers.
The decision, the government said on Saturday, was taken at a high-level meeting where Modi reviewed the status of COVID-19 and vaccine preparedness across states and union territories.
"After the detailed review, it was decided that in view of the forthcoming festivals including Lohri, Makar Sankranti, Pongal, Magh Bihu etc, the COVID-19 vaccination will start from 16th January 2021," it said.
With PTI inputs
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