2 min read.Updated: 09 Jan 2021, 09:47 PM ISTLeroy Leo
The probable cause of death was due to cardio respiratory failure as a result of suspected poisoning, the company said
Bharat Biotech explained that an adverse event during a clinical trial can be caused by various factors, including the patient’s underlying disease, other pre-existing conditions
A participant in Bharat Biotech International's Covaxin clinical trial in Bhopal died after getting either a shot of the covid-19 vaccine or placebo, and the cause of his death was found to be poisoning, the company said in a statement.
"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 company said. "We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded."
The death of the participant was found to be unrelated to the trial dose given to the participant in a preliminary review, despite it not being unblinded, and the death, categorised as a 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) as per all the required guidelines, the company said.
“This SAE has been thoroughly investigated and has been found not related to vaccine or placebo," the company said, adding that it will continue to cooperate with the investigation requirements from the police in Bhopal.
Bharat Biotech explained that an adverse event during a clinical trial can be caused by various factors, including the patient’s underlying disease, other pre-existing conditions or any other unrelated occurrence like an accident.
However, the company and its researchers at the Bhopal trial site have been accused of violating clinical trial norms through enrolment of people from poor and vulnerable groups during its phase 3 trial.
An activist group in working with survivors of the Union Carbide disaster in Bhopal said that the trial site recruited several hundred individuals from communities situated behind the abandoned Union Carbide factory, which was the site of the Bhopal Gas tragedy, and majority of the residents there are extremely poor and illiterate.
The activist group said that many of the residents were not aware that they are being recruited for a trial but were under the impression that they are getting vaccinated to protect themselves from covid-19. Some people were allegedly induced with a payment of ₹750, a substantial amount for poor daily wage earners. Many were neither provided with copies of the consent forms and participant information documents, nor followed up and monitored for adverse reactions, the activist group has alleged.
In some cases, where individuals experienced adverse reactions that required medical attention, medical services were not provided by the trial’s investigators.
The allegations were refuted by Bharat Biotech, which in its statement, said that the reimbursement of ₹750 to study participants is therefore guided by the Indian good clinical practice guidelines and approved by the site’s Institutional Ethics Committees, and was not an inducement.
The company also said that the informed consent form and process were followed for all participants of the Covaxin Phase III study, and they were documented and all copies are with the site.