Four organisations of survivors of 1984 Bhopal gas tragedy on Sunday wrote to the prime minister and Union health minister asking them to stop the ongoing trial of Bharat Biotech’s coronavirus vaccine Covaxin in the Madhya Pradesh capital. The letter came amid controversy over the death of a 45-year old volunteer in Bhopal, allegedly during the clinical trial of the vaccine. The deceased volunteer was a survivor of the Union Carbide gas leak tragedy.

The letter also demanded compensation for damages caused during the trial and punishment for those responsible for the alleged flouting of norms.

“At least 700 of the 1,700 people on who this vaccine, with unknown efficacy, is being tested, are people poisoned by Union Carbide,” Rashida Bee, President of Bhopal Gas Peedit Mahila Stationery Karmchari Sangh, one of the four organisations said.

The letter asserts that proper guidelines were not adhered to while receiving consent from volunteers in Bhopal, several of whom were survivors of the 1984 incident. It states that in December, People’s Hospital, a private medical college and hospital in the city went to localities where many of the survivors stay and announced that coronavirus vaccines were available, in order to recruit volunteers for the trial. The hospital also said that people who take the shot, would be paid an amount of Rs 750, as compensation for travel expenses and loss of daily wage, the letter claimed.

The letter sent by four groups – Bhopal Gas Peedit Mahila Stationery Karmchari Sangh, Bhopal Gas Peedit Mahila Purush Sangharsh Morcha, Bhopal Group for Information and Action and Children Against Dow Carbide – mentioned that several people who were recruited were from vulnerable groups, as per guidelines issued by the Indian Council of Medical Research. Additional safeguards prescribed by ICMR in such cases were not taken care of, the letter said.

The letter added that participants were not provided with copies of the consent forms, even though it was mandatory. In several instances, people were not given time to read the information sheet and consent form. This was despite the fact that the Hindi version of the two documents added a disclosure that they contain “technical language that is beyond the comprehension of any layperson, let alone persons with minimal education”, the letter said.

The information sheet and consent form in Hindi add a disclosure that they contain technical language that is beyond the comprehension of laypersons.

Guidelines related to insurance policy of the participants and their monitoring and follow-up after the trials were also flouted with, according to the letter.

“No records are kept of the health problems the trial’s participants have had following the shots and several have been turned away without tending to the adverse effects of the shots,” Rachna Dhingra of the Bhopal Group for Information & Action said.

Mentioning the death of the 45-year old categorically, the letter suggested that no follow up was done by the trial site. “Given the ethical violations in consenting participants, it is no surprise that the participant did not approach the trial site when he started experiencing symptoms and his health deteriorated,” the letter said. It added that the family of the deceased was given the postmortem examination report several days after People’s Hospital received it. The copy of the person’s consent form has still not been given to the family, it added.

Death of the volunteer

The 45-year old, who participated in phase 3 trial of Covaxin, died on December 21, nine days after he got the first jab. Bharat Biotech has, however, denied that the death was due to the vaccine. “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,” the company said in a statement, on Saturday. “We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.”

The company said that the volunteer had fulfilled all the criteria to be accepted as a participant in the trial and was reported to be healthy with no adverse event noted seven days after his dosing.

On January 3, India had approved vaccines developed by the Serum Institute and Bharat Biotech for emergency use. Bharat Biotech has manufactured India’s first indigenous vaccine candidate Covaxin in collaboration with the Indian Council of Medical Research and the National Institute of Virology. The Serum Institute is the local maker of Covishield, the vaccine developed by Oxford University and pharmaceuticals company AstraZeneca.