India's COVID-19 Vaccine Trial Participants Claim They Were Misled

It did not occur to him to call up the hospital, where he was given the injection, until this interview with IndiaSpend. Clinical trial sponsors and investigators are supposed to check on and keep records of participants' health. He then asked his son to call the hospital, but his son has not had credit on his phone for nearly five months, since he lost his job after contracting tuberculosis. With no money to make phone calls, Parihar could not contact a doctor about his poor health following the vaccine trial. He said he has not received any calls either.

The vaccine that Parihar was referring to is Covaxin, which was given restricted emergency approval in India, even as its clinical trials are under way. The indigenious vaccine is being jointly developed by Bharat Biotech, a private company, and the Indian Council of Medical Research, a government agency.

After reports of irregularities in the trials, this reporter visited Bhopal to investigate the allegations made by people living in low-income areas of the city. Many said they did not know they were part of a clinical trial and instead believed they had been given the actual COVID-19 vaccine. For most, the money was the reason they had agreed to take the jab. Many of them said they were illiterate and could not read the forms they had signed.

Residents also alleged that they had not been informed about the potential side-effects, or that they could be compensated for serious fallouts such as death or disability. Although Bharat Biotech has issued a press statement claiming that all reported adverse events have been duly recorded, many in the trial did not have mobile phones on which their health conditions could be inquired about. They said they had not been contacted by any other means, either.

Illness and death

On January 7, Bharat Biotech announced it had successfully recruited 25,800 volunteers across 26 sites to participate in the critical third phase of their clinical trial. The first two phases of the trials had about 800 participants.

The Covaxin trial in Bhopal is being conducted at People's University, which is located near Gareeb Nagar and Oriya Basti where hundreds of low-income families--many of them survivors of the 1984 Bhopal gas tragedy--live. Students have been out of school all year due to the pandemic and many men have been without jobs and incomes all through 2020, residents told IndiaSpend. Sewage is poor and residents have for long protested that water is contaminated since the 1984 leak.

In another part of Bhopal, Vaijanti, who uses a single name, wept as tens of television cameras and reporters stormed into her single-room rented home. Her husband Deepak Maravi had died nine days after he took part in the COVID-19 trial. She received the post-mortem report in January, which said he could have died from "suspected poisoning".

Bharat Biotech confirmed in a January 9 press statement that Maravi had taken part in its clinical trial. A preliminary review indicated that the "death is unrelated to the study dosing", it said, adding that it had been "thoroughly investigated" and found "not related to vaccine or placebo". The company said it could not "confirm if the volunteer received the study vaccine or a placebo as the study is blinded".

Maravi and Parihar had signed up for Bharat Biotech's clinical trial without informing their families, who found out only when they fell ill. Maravi's wife Vaijanti and Parihar both said they had not got a copy of the consent form which they had signed either.

"There were hundreds of people that day at the hospital waiting to get the vaccine. Everyone was poor like me. I could not see any well-off people there to take the injections," said Parihar. Now, he does not want to go back to take the second jab, which is due this month.

Company's claims vs people's experiences

Several trial participants in Bhopal told IndiaSpend that they thought they were being administered the actual vaccine and were unaware that they had signed up for a clinical trial. "I am illiterate so I could not read any of the papers they showed me... but I signed them," said Ram Singh Ahirwal, one of the participants in the trial, who also lives in Gareeb Nagar. Others recounted similar stories.

They also alleged they were not warned about the possible side-effects, and that their complaints of ill health after the trial were not followed up, recorded or treated.

India's clinical trial rules lay down how informed consent should be taken from clinical trial participants, including a separate procedure for those who may not be able to read and write or who may be 'vulnerable subjects'. For participants unable to read and write, an 'impartial witness' should be present during the entire informed consent process and sign on to the documents. The rules also specify that an audio-video recording of the informed consent process should be taken when 'vulnerable subjects' are involved.

"There was a videographer in the room who took audio-video recordings of the informed consent," said A.K. Dixit, dean of People's University. But several people IndiaSpend spoke to said they had not spotted any audio-video recording at the trial. "I did not see anyone recording the whole process on audio or video," Ahirwal said.

Bharat Biotech statement, apart from Maravi's death, addressed many of these issues.

It said that participation in the trial was decided based on defined inclusion criteria and the participants' health was assessed before being included in the trial.

It also said all adverse events and serious adverse events (SAEs), such as those which cause death or disability, had been reported to ethics committees and the Central Drugs Standard Control Organisation in accordance with the Indian law. According to their protocol, all participants were being followed up for tests and check-ups, it claimed.

But many, like Parihar, did not have money to contact the hospital and complain of their health issues after the trial, and others did not have a mobile phone to do so.

Regarding the payment of Rs 750 per visit to trial participants, the company said this is permitted under India's Good Clinical Practice Guidelines. The amount itself was decided by the ethics committees at institutes where the trials are being conducted.

The guidelines say that payments should not be "so large" such that it makes participants participate in the trial "against their better judgement (inducement)". On this, Bharat Biotech said their payment of Rs 750 was "not an inducement".

However, many of those interviewed by IndiaSpend said that Rs 750 was equivalent to two days' wages for them, and they had, like Parihar, found the money to be a good enough reason to take the injections.

Communication breakdown

Parihar is not the only one that Covaxin trial investigators have been unable to get in touch with. Jai Ram, a carpenter, told IndiaSpend he had felt some aches and weakness after the injection, but has not managed to communicate this to the trial investigators because he lost his phone soon after getting the jab. His friend Ahirwal, who also participated in the trial and received a follow-up call, told the investigators that all was well with him, and Jai Ram too. So Jai Ram's adverse event has also not been recorded in the trial.

While Ahirwal still wonders about compensations for the 1984 gas leak disaster, he is sceptical about the safety of the clinical trial he just participated in. "I did not know it was a trial. The doctors there did not explain anything about the vaccine trial but I overheard two of them discussing something about giving this vaccine first to animals and now to humans," said Ahirwal.

IndiaSpend has sent detailed queries to Bharat Biotech and the Indian Council of Medical Research (ICMR) regarding the allegations made by participants in the Covaxin clinical trial in Bhopal. The piece will be updated when they respond.

Same trial, different city

In Mumbai, 22-year-old Ronak, who goes by a single name, took part in Bharat Biotech's Phase 3 trials at Sion Hospital in December 2020. Unlike the chaotic situation in Bhopal, he "had a good experience", he told IndiaSpend in January, over the phone. A college student in a big city, Ronak's socio-economic profile is very different from that of the inhabitants of Bhopal's slums.

Quite unlike how the trial was conducted in Bhopal, here in Mumbai, Ronak said the people conducting the trial at Sion Hospital spent at least 10 minutes explaining how the process works. They let him ask questions and cleared doubts that he had. However, as in the case of many in Bhopal, he too did not read the consent form in full before signing. However, he was given a copy of the consent form to take home.

Like the participants in Bhopal, he too was paid some money (Rs 1,500) for participating in the trial. But he was not informed about the payment before signing up. He went of his own free will and found out that he would be paid after he took the second shot. This is in contrast to Bhopal, where participants alleged that they were told about the money first as a bait to get them to enrol.

"I doubt Bharat Biotech or any agencies doing its trials would go around in an affluent part of a big city with trucks and loudspeakers and offer people Rs 750 [per visit] and claiming it is for a vaccine," said Rachna Dhingra, who has been working with survivors of the Bhopal gas tragedy. In Bhopal, she said, participants were recruited from areas where a large number of Bhopal gas tragedy survivors reside. "Their health was already compromised from the gas leak in 1984," she said, in an allegation that the company has denied by stating that participants' health was assessed before the trial.

"It is these people who are also now being given the Covaxin trial shots without their proper knowledge or consent," Dhingra said, "Many subjects are also not being followed up or monitored and their adverse events are not being recorded or treated."

'Clinical trial mode'

Clinical trials in India are governed under the Drugs and Cosmetics Act, 1940 and New Drugs and Clinical Trials Rules, 2019.

On January 3, India's drug controller issued a press statement giving restricted emergency approval for two COVID-19 vaccines made in India, but said that Bharat Biotech's Covaxin would be administered in "clinical trial mode". Indian law has no provisions for administering vaccines in "clinical trial mode".

Two days later, the ICMR chief clarified that "clinical trial mode" means that those taking these two vaccines would need to give consent and be followed up. He did not say whether trial participants would receive compensation for any serious adverse events, though India has strict regulations in this regard.

Compensation is decided based on a formula that takes into account factors such as age of the participant, presence of co-morbidities and duration of diseases, congenital anomaly or birth defect and whether the serious adverse effect from the trial is reversible. The base compensation for deaths is Rs 8 lakh ($10,902).

Abroad, some of the major clinical trials for the COVID-19 vaccine have been paused, and investigations launched, on reports of deaths or other adverse events among trial participants. Last year, AstraZeneca paused its late-stage trial for a safety review after one participant reported an adverse reaction. Last October, Johnson and Johnson paused its clinical trial for the COVID-19 vaccine until a panel of experts could investigate an illness in one of their participants. In January, the Norwegian government also began a probe into the death of two people who took Pfizer's COVID-19 vaccine.

Here in India, the drug controller asked Serum Institute to stop recruiting for the AstraZeneca/Oxford University vaccine, after an adverse reaction was reported in a participant for the same vaccine trial in the United Kingdom.

Unlike Bharat Biotech's Covaxin, many of the COVID-19 vaccine front-runners have all made their clinical protocols and consent forms publicly available. (See clinical trial protocols for Moderna, AstraZeneca/Oxford University, Janssen, Pfizer, Novovax, CanSino and consent forms for Moderna, AstraZeeca/Oxford University, Janssen).

Good trial data means safe and effective vaccines

"Bharat Biotech's statement says they believe the death of Maravi is unrelated to the vaccine or placebo. They ought to explain the basis of their investigation and what facts they relied on to conclude this," said Anant Bhan, a researcher on bioethics based in Bhopal.

He also asked how this vaccine was approved in India, following this death: "India's expert panel also recommended Covaxin for approval in January, but the death of Maravi happened in December 2020. The drug regulator ought to explain whether the expert panel knew of this death and had factored it in when they gave emergency approval to this vaccine."

The irregularities in Covaxin trials are coming to light in Phase 3. "Phase 1 and 2 will likely pick up the most frequent and potentially serious adverse effects," said Jammi Nagaraj Rao, a public health physician and epidemiologist in the United Kingdom. "But safety also needs to still be monitored in Phase 3, which has a much larger cohort of participants."

Phase 3 has a larger cohort of participants, and these larger numbers enable the more infrequent side effects to be picked up too, Rao said. "Also, scientists will get a more accurate estimate of the probability of the common side effects. All this data, if collected well, will go into the information leaflet which accompanies a drug or vaccine. Good data from trials allows us to have warnings in these leaflets about side effects."

This makes informed consent vital, Rao said. It is during the process of obtaining informed consent that participants are made to understand that they must report side effects and remain in touch for follow up and monitoring. "It is necessary both for ethical and practical reasons of follow-up," Rao said, "If a large number of trial participants are lost during follow-up, this will cast doubt on the results from the study."

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