'We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded,' the vaccine major noted.
After the death of a 42-year-old volunteer in Bhopal, who took a dose of Covaxin in the clinical trial of Bharat Biotech's Covaxin, further spurred controversy over the emergency approval of the firm's covid vaccine, Bharat Biotech denied that the vaccine was the cause of the volunteer's death.
Vaccine maker Bharat Biotech on Saturday said the death of a volunteer in Bhopal, who took a shot of its COVID-19 vaccine Covaxin as part of the Phase III clinical trials, was not related to the medication.
"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 Hyderabad-based firm said 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, it noted.
"We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded," the vaccine major noted.
The Drugs Controller General of India (DCGI) has approved Oxford-AstraZeneca COVID-19 vaccine Covishield, manufactured by the Serum Institute and Bharat Biotech's Covaxin for restricted emergency use in the country.
In a statement, Bharat Biotech said the volunteer passed away on December 21, 2020 and the death was reported to the People's College of Medical Sciences & Research Centre by the son of the deceased.
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The volunteer, at the time of enrolment, had fulfilled all the inclusion and exclusion criteria to be accepted as a participant in the Phase III trial and was reported to be healthy in all the site follow-up calls post seven days of his dosing and no adverse effects were observed or reported, it said.
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 cardio-respiratory failure as a result of suspected poisoning and the case is under police investigation as well, the vaccine maker said.
In accordance with the provisions of the New Drugs & Clinical Trials Rules, (NDCT rules 2019) the serious adverse event was reported by the site team to the Institutional Ethics Committee, the Central Drugs Control Standards Organization (CDSCO) and the Data Safety Monitoring Board (DSMB) in accordance with all the required guidelines, it 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, Bharat Biotech said. 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, it added.
All data and reports on this SAE has been submitted to the Site Ethics Committee, CDSCO and DSMB, the vaccine major said. The company is also continuing to cooperate with the investigation requirements from the Madhya Pradesh Police in Bhopal, it added.
"Our sympathies are with the family of the deceased. However, 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 is this intent on compliance, quality and ethics, that we have enlisted the services of an international contract research organisation to conduct our phase III clinical trials," the company noted.
In December, Haryana Health Minister Anil Vij had tested positive for coronavirus days after participating in the trial of Covaxin. He had participated in a trial on November 20, 2020.
Bharat Biotech had termed the vaccine safe and efficacious and said that Covaxin is based on a two-dose schedule and its efficacy is determined 14 days post the second dosage.