No Consent, No Follow-Up: Severe Lapses In Covaxin Trials In Bhopal, Claim Gas Tragedy Victims

Many respondents complained that they were not told that they were involved in COVID-19 vaccine studies. Those who fell ill after the vaccine was given were told to pay for treatment.

A man from Madhya Pradesh reportedly died in a shocking development in the Center’s efforts to provide a potential cure for citizens against the deadly Covid-19 virus after participating in the ‘Covaxin‘ vaccination trial in December.

The 42-year-old Bhopal volunteer Deepak Marawi died barely 10 days after he had participated in a private hospital clinical trial for the vaccine, hospital vice-chancellor said on Saturday.

“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,” Bharat Biotech said in a statement.

Deepak Marawi’s family members, a tribal community, claimed that the Covaxin injection was given to him and his colleague during the trial.

“He felt uneasy when he returned home and experienced some health problems. On December 17, he complained of shoulder pain. He spewed foam two days later. He refused to see a doctor say that he was going to be okay in a day or two. He was rushed to hospital when his condition worsened, but he died midway (on December 21),” they said.

Severe Lapses In Covaxin Trials In Bhopal

Trial participants in Bhopal, who, by the way, were also victims of the 1984 gas disaster, confirmed to IANS “severe violations” of the model code of conduct relating to studies, including the absence of consent and no follow-up of their health following the development of adverse reactions at a specific clinical trial site after the first dose.

They claimed that they were not told that they were participating in trials by the People’s College of Medical Sciences and Research Centre, a private hospital which is one of the 26 sites conducting phase 3 trials of Bharat Biotech’s Covid vaccine, Covaxin.

Many of them, who claim to be illiterate and belong to severely disadvantaged sections of society, said that after believing they were being vaccinated, they signed up. They were also seduced by the clinical site for enrolment with a Rs 750 cash payment.

Rashida Bee, President of the Bhopal Gas Peedit Mahila Stationery Karmchari Sangh and a recipient of the Goldman Environmental Prize, said that at least 700 of the 1,700 people on who this vaccine, with unknown efficacy, is being tested, are people poisoned by Union Carbide.

Man Singh Parihar, 70, who works as a construction worker, had volunteered for the trial on December 21 after he was told that he would be given a Covid vaccine for free in addition to Rs 750.

“I was not told that it was a trial or study. They told me that I won’t catch corona after this injection and I was promised Rs 750 as well. They conducted a blood test and a general checkup and gave me a shot,” he said.

“Three days after the shot, I suffered severe cold, fever, and dizziness. Till day, my appetite has not recovered,” he added.

After developing the adverse reactions, Parihar’s family took him to a local doctor. Asked why he didn’t go to the hospital, he claimed that he was never told to report there if side effects occur. “The local doctor practices near my house. I chose to go there since he charges less money than the hospitals,” he said.

Chanda Devi, 60, who sells artificial jewellery door to door, also suffered fever, vomiting, and dizziness days after taking the shot on December 19. “Due to illness, I am unable to go to work now. Had I known that it was a trial, I would have never taken the jab,” she said while regretting taking the shot.

The participants were provided forms to record the changes in their body post the jab. However, they alleged that the investigators assured them that no side effects would occur.

Rachna Dhingra, a public health activist associated with Bhopal Group of Information, alleged that the People’s Medical College exploited the vulnerability of the victims to achieve maximum recruitments in the trial.

“It has enrolled more than 1,700 participants in the Phase 3 trial, after meeting the initial target of 1,000 participants, at a time when it was reported that other sites were facing difficulties in recruiting volunteers. Most of them are gas tragedy victims from a poor background and are illiterate,” she said.

She also said that communities from Gareeb Nagar, Shankar Nagar, Oriya Basta, Kainchi Chhola, JP Nagar, etc, situated behind the abandoned Union Carbide factory, were chosen for the trial since they are in vicinity to the site.

Dr. Anant Bhan, Bioethics and Global Health Policy researcher, said that not providing informed and electronically documented consent for volunteers identified within vulnerable groups is contrary to the rules. “New Drugs and Clinical Trials Rules, 2019, clearly states to record audio or visual while taking consent from such volunteers,” he said.

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