The death of a 45-year-old vaccine volunteer in Bhopal, the capital city of central India’s Madhya Pradesh state, is unrelated to the vaccine and is believed to be due to suspected poisoning, the pharma company Bharat Biotech said.
Deepak Marawi, a daily wage labourer and father of three children, received his first dose on December 12. He died nine days later on December 21, and his wife has alleged it was “because of the vaccine”. The police are investigating the charge.
However, Dr Anil Dixit, the Dean of the city’s People’s Medical College, where the trials are underway, said on Friday that the man died due to “other reasons” and not a severe adverse effect.
“It has come to (our) notice that a volunteer – Deepak Marawi – died. However, the death was due to other reasons. And it was not severe adverse effect (to the vaccine),” Dr Dixit said in a statement.
Inclusion and exclusion criteria
Bharat Biotech asserted that Deepak Marawi had fulfilled all medical criteria to be part of the trial, and had reported healthy during follow-up calls.
“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 he was reported to be healthy in all the site follow-up calls post seven days of his dosing, and no after-effects were observed or reported.
As per the post-mortem report of the Gandhi Medical College, 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,” Bharat Biotech said in its statement.
“The volunteer passed away nine days after dosing. Preliminary reviews by the site indicate the death is unrelated to the study dosing,” it added.
Bhopal Police have initiated an investigation. They also sought answers from the People’s Medical College on seven key points, including details about vaccine and a sample.
The police have also asked for a copy of the informed consent form, certified copies of medical check-ups conducted before enrollment in the trial and other documents linked to the clinical trial.
Followed guidelines: MP Minister
Madhya Pradesh Health Minister Prabhuram Chaudhary said that all vaccine trials in the state take place in accordance with the set down guidelines of the Centre and the ICMR. He said that any death was “unfortunate” and that Marawi’s, in particular, had saddened him.
“My understanding is that after effects of injection show within 30 minutes. If not, then it will show within 24-48 hours of the injection. My information is also that his wife said he was frothing at the mouth, when he died. This indicates, it is not linked to the vaccine,” he told reporters.
Chaudhary also pointed to the results of the post-mortem and added, a team of medical experts would study the death. “We will wait for reports and take action as needed,” he said.
Study ‘blinded’: Bharat Biotech
Bharat Biotech said that it cannot confirm if volunteer Marawi had, in fact, received a dose of the vaccine since the study was “blinded”. It means the recipients do not know whether they are being given the vaccine or a place.
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 the adverse events and serious adverse events be reported. This SAE has been thoroughly investigated, and has been found not related to vaccine or placebo, it added.
‘Our sympathies are with the family’
All data and reports on this SAE have been submitted to the Site Ethics Committee, the CDSCO and the DSMB. 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. Covaxin is based on a two-dose schedule, and its efficacy is determined 14 days post the second dosage, it said.
He was ‘fully healthy’: Victim’s wife
Marawi’s wife, Vaijanti Marawi, alleged that her husband was “fully healthy” till he got the trial dose of the vaccine. And his condition declined shortly afterwards, she added.
“He got the trial dose of the vaccine on December 12. He was fine for seven days… was eating food. Then he started feeling dizzy. I told him to go to the hospital but he refused. On December 21 he collapsed. He died because of the vaccine. We did not get help from anywhere,” she claimed.
She also refused to accept that Marawi could have consumed poison.
“I’m left now with nothing, but to wash utensils in others’ houses to feed my children,” she said.