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The Phase-III trials of Covaxin, the Covid-19 vaccine candidate being developed by Bharat Biotech, received a jolt as a volunteer passed away.
“We would like to state that a 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,’’ Bharat Biotech said in a statement on Saturday.
Covaxin has been granted emergency use authorisation by the Drug Controller General of India and the vaccination is set to begin shortly.
As of now, about 25,800 volunteers have been recruited by the company and Phase-III trials are under way in different locations.
Healthy
The Hyderabad-based vaccine maker, however, claimed the volunteer had ‘fulfilled’ all the inclusion and exclusion criteria to be accepted as a participant in the trial and was reported to be healthy in all the site follow-up calls post-seven days of his dosing; no adverse events were observed or reported. As per the post-mortem report issued by the Gandhi Medical College, Bhopal, the probable cause of death was cardio respiratory failure as a result of suspected poisoning. The case is under police investigation.
“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 said.
Reported
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.
“We are also continuing to cooperate with the investigation requirements of the Madhya Pradesh Police in Bhopal,’’ the vaccine-maker said.
“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,’’ Bharat Biotech said.