The man reportedly died nearly ten days after he participated in the clinical trial for Covaxin held at a private hospital in Bhopal.
The case comes amid concerns being raised by industry experts and opposition parties on the emergency approval granted to Bharat Biotech’s coronavirus vaccine ‘Covaxin’ without publication of efficacy data. The Phase III clinical trials are underway.
According to Bharat Biotech the Serious Adverse Event (SAE) was reported to the Institutional Ethics committee, the Central Drugs Control Standards Organization (CDSCO) and the Data Safety Monitoring Board (DSMB) in accordance to all the required guidelines.
“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. This SAE has been thoroughly investigated and has been found not related to vaccine or placebo,” it said in a statement.
“We are also continuing to cooperate with the investigation requirements from the Madhya Pradesh Police in Bhopal,” it further said.
The participant had passed away on December 21. Bharat Biotech said that the participant was reported to be healthy in the follow up calls post 7 days of his dosing and no adverse event were observed or reported then.
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. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded,” it further said in a statement.
The company said that they follow good clinical practices with focus on patient safety.
“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 organization to conduct our phase III clinical trials,” it further said