The Pharma giant Bharat Biotech issued a statement on the death of a volunteer

Bharat Biotech issued a statement on the death of a volunteer of the phase 3 trial. The pharma giant said that the death is not related to the study.

Bharat Biotech is a biotechnology company based in India. The Hyderabad-based company is manufacturing vaccines against coronavirus in association with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune. It has received approval for the 3rd phase of the trial from the Drugs Controller General of India (DCGI).

 In a statement issued by the company, it said “preliminary reviews by the site indicate that the death is unrelated to the study dosing”.

The trials were conducted in the peoples’ medical college and hospital in Bhopal, Madhya Pradesh. The company has completed phase 1 and phase 2 but phase 3 is still left for which it recently got permission. Phase 3 of the trial will include 25,000 participants.

On the death of the volunteer, Bharat Biotech issued a statement and denied that the cause of death was the vaccine.

“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. 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” said Bharat Biotech.

The company also said that they are not sure if the dead volunteer was given the vaccine or placebo. 

Placebo is a substance used for treatment with no therapeutic value. Inert tablets (like sugar pills), inert injections (like saline), sham surgery are commonly used as Placebo.  

Deepak Marawi, a 42-year-old volunteer who belongs to Bhopal died after 9 days of participating in the trial. 

Dr. Rajesh Kapur, vice-chancellor of People’s Medical College and Hospital said, “It [the vial containing the liquid for trial] comes covered and coded. During the trial, 50 percent of people get the actual injection while the rest are given saline.”

MP CM Shivraj Singh Chouhan also issued a statement on the incident. 

He said“Viscera sent for testing. I urge all to take this matter sensitively so that no unnecessary misconception on vaccines is formed that’ll affect vaccination. The report will come, but I’m confident that if there’s an after-effect, it shows in 24 hours or 2-3 days, not after several days,”

Bharat Biotech further added “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. The NDCT rules mandate that all adverse events (AE) and serious adverse events (SAE) be reported, whether related to the trial medication or not. This SAE has been thoroughly investigated and has been found not related to vaccine or placebo. All data and reports on this SAE have been submitted to the Site Ethics Committee, CDSCO [Central Drugs Standard Control Organization] and DSMB [Data and Safety Monitoring Board].”

The company had also sparked controversy with the allegations of not following the protocols and violating the consent forms. The source said that the volunteers showed adverse effects due to vaccination many of whom were the survivors of the Bhopal gas tragedy. 

The company issued a clarification on the matter that they are following all the protocols, rules, and regulations. The official statement read, “We would like to reiterate that we conduct our clinical trials in compliance with the study protocol, Good Clinical Practices (GCP) Guidelines as well as with all applicable statutory provisions and the focus at all times is on patient safety.”

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