Questions over India’s Covaxin side effects, ethical violations — India

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A shadow is lurking over the trial process of India’s homegrown Covid-19 vaccine.

Covaxin, the novel coronavirus vaccine co-developed by Bharat Biotech and the Indian Council for Medical Research, has been accused by some trial participants of sidestepping procedures and not making adverse events public. It has denied these charges, but trial volunteers want the government to intervene and halt the phase 3 human trials.

Bharat Biotech began courting controversy on On Jan. 4, when scientists expressed grave concerns over the hasty approval given to Covaxin. Now, its trial participants in Madhya Pradesh’s Bhopal allege that they were not informed that the jab would be given to them as part of a clinical trial. Covaxin’s third phase of human trials has 25,800 participants across the country.

Lapses in vaccine trial process

During a press conference on Jan. 10, some trial participants alleged that neither Bharat Biotech nor the People’s College of Medical Sciences & Research Centre, Bhopal, one of the trial sites, followed due process while enrolling them.

The process for enrolling trial volunteers should includes receiving an informed consent form, regular follow-ups from those conducting the trials, and access to healthcare services in the event of side-effects. Participants have alleged that they have had to seek medical care elsewhere because the hospital where the trial took place did not grant them care.

Many have alleged that they feel nauseous, get frequent headaches, backaches, and feel a loss of appetite since receiving the jab. For instance, Gulabi Devi, a Bhopal resident, claimed that her son, a daily wager, fell ill 10 days after receiving the trial shot. She alleged that People’s Hospital refused care, and he had to seek medical attention at a private hospital and bear the cost on his own.

The more serious concerns come from the death of a volunteer on Dec. 21, 2020, nine days after receiving the first dose of the Covaxin trial. Bharat Biotech has confirmed that the participant was a part of the trial, but because the trial is still blinded, it could not confirm whether he received a placebo or active vaccine shot.

The company has also said that the volunteer’s death was because of “cardio-respiratory failure as a result of suspected poisoning,” and that a preliminary study found that the death was unrelated to the vaccine trial. Bharat Biotech has also said that as part of its follow-up, no adverse events were reported by the volunteer seven days after the first dose was administered.

But advocacy groups are not convinced by the company’s explanations.

The allegations against Covaxin

In a letter to prime minister Narendra Modi and health minister Harsh Vardhan, activists have detailed the ethical violations that took place during the enrollment of volunteers for Covaxin’s phase 3 trials.

Their first point of concern is that unlettered and uninformed residents were herded into vehicles and enrolled as trial participants. “These vehicles were accompanied by staff of the hospital who recruited several hundred residents of these communities. In other cases, daily wage labourers were recruited from their peetha (gathering for daily wage labourers) for the trial,” the letter, signed by Rashida Bee, Nawab Khan, Rachna Dhingra, and Nausheen Khan, who represented various Bhopal gas disaster relief groups.

A sum of Rs750 ($10) was also paid to each trial participant, which the activists claim was meant to lure impoverished groups into the trial. Bharat Biotech, which began enrolling phase 3 trial participants on Nov. 16, was facing shortages in the number of participants willing to come forward even a month later. It was able to complete its targeted enrollment of 25,800 volunteers by Jan. 7.

But the company has denied the charge that the Rs750 payment to volunteers was meant to coerce them. In a press statement (pdf) on Jan. 9, the company said, “The decision taken for the Covaxin Phase III study was to reimburse all participants at the rate of Rs750 for each study visit. The reimbursement amount was approved by every Institutional Ethics Committee (IEC) at the study sites...It is NOT (sic.) an inducement.”

Further, the activists from Bhopal alleged that the process of informed consent was not followed diligently. As part of the trial norms, participants are entitled to receive a copy of their consent forms, but that was not the case with People’s Hospital, said the activists.

“In the majority of cases that we have interacted with, the participants from these communities had not received any hard copy of their signed consent forms even after receiving the first dose. Participants remembered signing in many places during the visit but they were not given copies of their consent forms,” they wrote in the letter to Modi.

In the case of illiterate participants, an audio-visual recording of the informed consent is required and was also included as a provision in the written consent form. But trial participants who came forward during the press conference on Jan. 10 said that no such recordings were made.

Reporting and halting the vaccine trial

When the Oxford-AstraZeneca vaccine development reported an adverse event, the trials were halted in the UK on Sep. 9, 2020. In India, the vaccine’s manufacturer and trial partner, Serum Institute of India (SII), received a notice from the national drugs authority for not notifying this adverse event.

SII then briefly halted the trial, till both the UK and Indian drugs authorities were satisfied with the safety studies. Such was not the case for the Covaxin trials, and the trial was not halted even after the death of a trial participant.

In fact, the letter from the activists alleges that the details of the fatality were not even made public till the media reported it. “There is no information about the procedure being followed by various parties—the PI, Institutional Ethics Committee, Data Safety Monitoring Board and DCGI—in investigating the death or its current status,” the letter said.

Bharat Biotech, on its part, has been firm that it followed all ethical codes. “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,” it said in its statement.

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