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"The volunteer, at the time of enrolment, had fulfilled all criteria to be accepted as a 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.
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 authorization 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.
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 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.”
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 a 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. 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,” Chouhan said.
Clinical trial participation
Bharat Biotech added, "Participation in a clinical trial is purely voluntary. Only eligible participants are enrolled in a study after a careful assessment of their various health parameters."
"Deaths are routinely recorded and reported in human clinical trials, especially in large clinical trials with diverse population demographics, and with older age groups. The current rate of death in India is 7.3 deaths/1000, we would expect to see a rate far lower in our Phase 3 trials," the vaccine manufacturer added.
Monitoring of participants
"All participants in a clinical trial are monitored on an ongoing basis as per the study protocol. In the Covaxin Phase 3 trial, we can confirm that all participants are being followed up on and monitored on an ongoing basis as per the study protocol to ensure the safety of all participants," Bharat Biotech said.
It went on to add that the development of indigenous Covaxin is a matter of great pride and its focus during the development of the vaccine and the clinical trials has been on ensuring patient safety.