Activists raise red flag around Bharat Biotech's Covaxin trial in Bhopal

Write to PM and health minister, call for an independent inquiry

Fresh trouble brews for Bharat Biotech’s Covaxin trial. A group of activists wrote a letter to Prime Minister (PM) Narendra Modi and the Union Health Minister Harsh Vardhan, drawing their attention to alleged violations in the Phase-3 clinical trial at a Bhopal site, where most of the volunteers recruited were from communities affected by the Union Carbide gas leak. Activists have requested the PM to stop the trial at the site and conduct an impartial, independent inquiry.

Activists have alleged that the death of a 42-year-old trial subject in Bhopal was not recorded in the minutes of the meeting of the Subject Expert Committee that recommended approval of the vaccine. The subject passed on December 21, nine days after being dosed.

Samiran Panda, head of epidemiology and communicable division, Indian Council of Medical Research (ICMR), said: “Any serious adverse event (SAE ) occurring during the trial is being followed through with stipulated steps of timely reporting to appropriate committees and agencies. Causality assessment to examine the link of the investigational product (vaccine) — if any — with the reported SAE is also being conducted."

In the letter, activists have claimed that the trial site did not follow up with the participant during the nine days following the administration of the jab. “There is no information about the procedure being followed by various parties — the Principal Investigator, Institutional Ethics Committee, Data Safety Monitoring Board, and the Drugs Controller General of India — in investigating the death or its current status. The deceased’s family managed to access a copy of the post-mortem report weeks after the event, and several days after People’s Hospital obtained the same. The family has still not been given a copy of the deceased’s informed consent form or any documents related to his participation in the Covaxin trial,” they noted.

When asked if vaccination can lead to poisoning (which is prima facie the cause of death of the subject), Panda said: “With all carefully conducted toxicity studies, quality-control measures observed during production, supply, and administration, along with safety data generated through earlier phases of the clinical trial — poisoning because of vaccination seems extremely unlikely."

Rachana Dhingra from the Bhopal Group for Information and Action, along with other local activists, have asked the PM’s Office to intervene immediately and stop the clinical trial of Covaxin at the People's College of Medical Sciences & Research, Bhopal.  They also want the government to form an independent body to conduct an “impartial, transparent, thorough, and time-bound investigation to ascertain violations of ethics, protocols, and legal requirements pertaining to conduct of the clinical trial”.

On Sunday afternoon, several trial subjects at the site in Bhopal shared their stories with the media through a press conference. The subjects, who claimed they cannot read and write, all alleged that no video recording of their consent was done. Most of them seemed unclear about what the trial was for, the concept of getting a vaccine or a placebo, and that they can approach the site hospital if they fall sick. A lady calling herself Jeetendra Nawaria’s mother recounted her son's experience. “My son fell sick soon after the jab, and when we went to a hospital we were asked to pay Rs 450. We cannot afford that.... now, finally, after intervention from activists, he has been admitted in a hospital and is undergoing treatment for liver ailment,” said the lady, worried as the son is the sole earning member of the family.

Trial subjects claimed that several people in vehicles visited their respective communities and announced that everyone would be paid Rs 750 for getting a ‘Covid-19 vaccine’. “The Rs 750, meant to be a reimbursement of travel expenses and the loss of daily wages to trial participants, is a substantial sum for such poor communities and appears to have been used to induce people to come forward," the letter said.

It further added that the National Ethical Guidelines for Biomedical and Health Research involving Human Participants and the National Guidelines for Ethics Committees Reviewing Biomedical and Health Research During Covid-19 Pandemic published by ICMR deems communities that are socially, economically, or politically disadvantaged along with those who are able to give consent but whose voluntariness or understanding is compromised because of their situational conditions, as vulnerable groups and mandates additional safeguards in the conduct of research.

"The participants, owing to their economic, education, and compromised health status owing to the gas disaster and water contamination clearly fall within the definition of vulnerable groups according to the above,” the activists said.

Bharat Biotech issues response

The vaccine maker has said that participation in a clinical trial is purely voluntary. "Every clinical trial has a well-defined inclusion and exclusion criteria to determine who is eligible to participate. Only eligible participants are enrolled in a study after a careful assessment of their various health parameters. These participants may come from various strata of society and are a representation of different socio-economic demographics to ensure that there is diversified representation as required," it said.

It added: "As per the post-mortem report issued by Gandhi Medical College, Bhopal,  the probable cause of death was due to cardiorespiratory failure as a result of suspected poisoning and the case is under police investigation. The death... is unrelated to the study dosing.”

Moreover, it said that the  volunteer, at the time of enrolment, had fulfilled all the inclusion and exclusion criteria to be accepted as a participant in the Phase-3 trial and was reported to be healthy in all the site follow-up calls after seven days of dosing, and no adverse events were observed or reported.

The vaccine maker said that the SAE 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. “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 such as an accident,” the firm said.