Hyderabad-based Bharat Biotech, which developed India’s COVID-19 vaccine Covaxin, has clarified that the death of a 42-year-old volunteer from Bhopal in Madhya Pradesh, who took a dose of the indigenous Coronavirus vaccine in the clinical trial of the vaccine, was “not related” to the vaccine or placebo.
They informed that the volunteer who participated in the Phase III trial of Covaxin on December 12, 2020 was reported to be healthy in all follow-up calls until seven days from the date the vaccine was administered to him.
“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,” the Bharat Biotech statement read.
The volunteer, at time of enrolment, had fulfilled all criteria to be accepted as participant in Phase III trial & was reported to be healthy in all site follow up calls post 7 days of dosing & no after-effects were observed/reported: Bharat Biotech on a death in Phase III trial pic.twitter.com/RMZsE02WmF
— ANI (@ANI) January 9, 2021
“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.
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: Bharat Biotech
— ANI (@ANI) January 9, 2021
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, furthered the Hyderabad based company.
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: Bharat Biotech https://t.co/u9otZgir0T
— ANI (@ANI) January 9, 2021
Deepak Marawi (42), the volunteer from Bhopal Madhya Pradesh, died 10 days after he had participated in the clinical trial for the vaccine at a private hospital. The doctor who administered the vaccine said that Marawi was kept under observation for 30 minutes after the trial as per the guidelines before being allowed to go. “We monitored his health for 7 to 8 days,” he added.
Speaking about the unfortunate incident, Madhya Pradesh Health Minister Dr Prabhuram Choudhary said: “The after-effects of the vaccination are visible in a person within 30 minutes. No side-effects were seen even between 24 and 48 hours of vaccination. The post-mortem report suggested poisoning,” he said.
Meanwhile, Madhya Pradesh CM Shivraj Singh Chouhan urged people to desist from spreading misconceptions on the vaccine. Chouhan stated that the matter must be handled sensitively so that the vaccination rollout may not be affected. He added that the state government is awaiting the deceased’s viscera test reports.
“Report will come but I’m confident that if there’s after-effect it shows in 24 hrs or 2-3 days, not after several days”, opined Chouhan.
Viscera sent for testing. I urge all to take this matter sensitively so that no unnecessary misconception on vaccine is formed that’ll affect vaccination. Report will come but I’m confident that if there’s after-effect it shows in 24 hrs or 2-3 days, not after several days: MP CM https://t.co/IAoaV4TmkP pic.twitter.com/dyoPlGJniS
— ANI (@ANI) January 9, 2021
It is notable that after the Bharat Biotech vaccine was approved by authorities, opposition parties and left-liberals had attacked the govt, alleging that the safety of the vaccine is not proven yet. After the death of the trial participant, the matter was used by them to further spread propaganda against Covaxin. But it is notable that it is not known whether the man received the vaccine or placebo. As a standard practice in clinical trials, only 50% of the participants get the vaccine, while the rest 50 get a placebo. The allocation of vaccine and placebo is done in a randomised process, and the recipients of the same are kept confidential.
COVAXIN developed by Bharat Biotech gets Drugs Controller General of India (DCGI) nod
Hyderabad-based Bharat Biotech successfully developed COVAXIN™ in collaboration with the ICMR and National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech for the effort.
It is pertinent to note here that on January 3, 2021, the Drugs Controller General of India (DCGI) had approved the manufacture of Coronavirus vaccine by Serum Institute of India (SII) and Indian company Bharat Biotech.
Covaxin 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.
A study on the Phase 1/2 trial had shown that the therapeutic doesn’t cause any serious side effects.
