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Death of Covaxin phase 3 volunteer not related to vaccine trial, says Bharat Biotech

Bharat Biotech says it has followed necessary protocol and preliminary review shows death unrelated to study. Volunteer sample being tested to determine cause of death. 

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New Delhi: Pharma giant Bharat Biotech Saturday said the death of a volunteer participating in the clinical trials for the Covid-19 vaccine Covaxin was unrelated to the study.

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

This followed Dr Rajesh Kapur, vice chancellor of People’s Medical College and Hospital where the trial was conducted, telling news agency PTI that the 42-year-old volunteer had died 10 days participating in the trial.

A Bhopal resident, Deepak Marawi had participated in the Covaxin trial held on 12 December 2020. He died on 21 December.

Bharat Biotech is manufacturing India’s indigenous Covid vaccine in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune.

On 3 January, the Modi government granted the vaccine emergency use authorisation despite incomplete phase 3 trial data, sparking a controversy. The government had also granted emergency use authorisation to Oxford-AstraZeneca’s Covishield, being manufactured by the Pune-based Serum Institute of India.

India will begin its national immunisation drive on 16 January, starting with healthcare and frontline workers.

While Bharat Biotech has completed phase 1 and 2 trials, phase 3 is still underway across 25 centres in India, including over 25,000 participants.


Also read: How India’s regulatory pitfalls helped Covishield and Covaxin get rapid approval


What the statement says

In its statement, Bharat Biotech cited the post mortem report, which says the cause of death is cardio-respiratory failure as a result 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 cardio respiratory 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.”

Bharat Biotech also said the company cannot confirm whether Marawi had received the vaccine or the placebo. “We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded,” the statement added.

Dr Kapur had told PTI that it cannot be confirmed if Marawi had been given placebo or the vaccine. “It [the vial containing the liquid for trial] comes covered and coded. During the trial, 50 per cent people get the actual injection while the rest are given saline,” he said.

In a statement issued Saturday, Madhya Pradesh Chief Minister Shivraj Singh Chouhan said Marawi’s sample was sent for a viscera test to determine the exact cause of death. “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. Report will come but I’m confident that if there’s after-effect, it shows in 24 hours or 2-3 days, not after several days,” Chouhan said.


Also read: Everything you need to know about Covaxin, India’s controversial Covid vaccine candidate


Trials in compliance with study protocols

Bharat Biotech said that several underlying conditions could cause adverse effects in volunteers undergoing trials.

“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 has been submitted to Site Ethics Committee, CDSCO [Central Drugs Standard Control Organisation] and DSMB [Data and Safety Monitoring Board],” the statement said.

The company also said the trial is following the necessary protocol. “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,” it said in the statement.

Bharat Biotech courted controversy recently after reports emerged that the company had violated consent norms and adverse effects emerged in candidates, many of whom are survivors of the Bhopal Gas Tragedy.


Also read: This is how Bharat Biotech changed expert panel’s mind on Covaxin in a day and got approval


 

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