Bhopal: Saraswati, 30, a resident of Udiya basti in Shankar Nagar, is among the Bhopal residents who have participated in the Covaxin clinical trial in the Madhya Pradesh capital. However, she claims she wasn’t aware it was a trial, where participants are as likely to get the vaccine as a placebo. Researchers at the People’s University of Bhopal trial site, she says, drew her in with a promise of assured Covid protection.
Maan Singh, another resident of the area, recounts a similar experience. He said he was recruited with the promise of protection against Covid-19. According to him, he was told that he could get the vaccine for free now, or pay for it later when it was officially launched.
Saraswati and Singh are not alone. Similar claims have been made by others engaged for the clinical trial of Bharat Biotech’s Covaxin in Bhopal, which is being conducted here by the People’s University, a private institute.
Some participants have reported experiencing a spell of illness after getting the shot — one fatality has been reported too, but not established as a consequence of the vaccine.
Activists have also raised concern about the university roping in survivors of the 1984 Bhopal gas tragedy for the trial, noting that the health of such patients already stands compromised by exposure to the deadly methyl isocyanate gas during the leak.
However, the university denies the claim that participants have been kept in the dark about the nature of the exercise, and say all checks and balances are in place. The university administration also insists it follows a rigorous inclusion and exclusion criteria to avoid susceptible subjects.
Indigenous candidate Covaxin is one of the two vaccines — the other is Oxford-AstraZeneca’s Covishield — that has been approved for India’s vaccination exercise, which begins Saturday.
Both have received emergency-use authorisation, and their trials will continue even as they are rolled out for public use.
The clearance for Covaxin has been issued on the basis of incomplete Phase 3 trials, and thus comes with several conditions for trial sponsors Bharat Biotech and Indian Council of Medical Research (ICMR), including regular follow-ups with recipients. Its trial is currently underway at 26 sites around India.
‘In the dark’
The People’s University is located in the Bhanpur area of the city. For the Covaxin trial, it is recruiting people from a 4km radius around the campus, in keeping with the mandate they have received. All participants get Rs 750 each for taking two shots — the Covaxin vaccine schedule comprises two shots to be given 28 days apart. The sum is meant to be compensation for work hours lost for the trial as well as travel expenses.
Located on the outskirts of Bhopal, this perimeter comprises group housing societies inhabited by middle-class households, as well as slum clusters. The Union Carbide facility where the leak occurred, is also located in Bhanpur, so the areas nearby are inhabited by many survivors of the gas tragedy.
Shankar Nagar, one of the areas in the campus vicinity, is inhabited by several daily wagers who earn anything between Rs 200 and 500 a day. For trial recruitment, residents said, a vehicle used to come from People’s University asking people to participate in the programme.
According to most of the residents who participated in the trial, they were told they were getting vaccinated and this would protect them from the virus. Many said they were told the same vaccine would cost Rs 4,000 when officially launched.
Saraswati, a resident of Shankar Nagar, received two shots under the trial — on 7 December and 4 January.
“One madam and two sirs came and said this is the corona vaccine and I won’t get coronavirus after this. They also said in case I faced any problem afterwards, they would do the treatment,” said Saraswati, a widow with three children.
Talking about the participation documents, including the consent form, she signed, she said, “It was written in English, ma’am, and I couldn’t read much. They told me I won’t get corona after getting this so I agreed. I also got Rs 1,500 for it.”
Maan Singh, another resident of the area, is a daily wage labourer who says he has not been able to go to work since he received the vaccine. He received one shot under the trial, on 21 December.
“A number of vehicles had come (to the area) and were announcing ‘come and get vaccinated’. They said, ‘if you don’t get it done now, you will have to pay from your own pocket for the vaccine later, whereas we are giving you Rs 750 for it’,” he said.
Soon after getting the shot, Singh added, he got fever, flu and “now my arms and legs have become numb”.
“We went to the hospital again and they said I was fine and gave a few medicines,” added Singh, who is the sole breadwinner for his family since his son is a TB patient.
Gulab Pasi, a Bhopal gas tragedy survivor, said she received the shot at a camp she spotted while out to deposit cash in the bank.
“They had put up a camp and they were examining us there. A lot of people were there. They said this virus is circulating, so get this vaccination and if you face any problem later you can call us,” she said. “We are illiterate so could not read it (consent form and other documents). But I am completely fine. I am waiting for the second shot now,” she told ThePrint.
Radha Devi, another resident of the area, had a different experience.
“I got one shot in December and didn’t get any paper at the time. Then I got another shot in January and was given some papers. I fell sick soon after that. I started vomiting and got diarrhoea. I have not been working since then,” she said. “I was not told that it was a trial and they did not give us any information.”
Manu, a fellow trial participant, said she was denied the second shot. “They said it’s the Covid vaccine, so we went, to avoid getting an infection. They gave us Rs 750. When I went the second time in January, they said ‘you have blood pressure, so you can’t be given the vaccine’, and asked me to purchase some medicines, which I could not buy,” she added.
Rachna Dhingra of the Bhopal Group for Information and Action, a 35-year-old voluntary organisation working for the gas tragedy survivors, said “people whose health is compromised due to the Union Carbide’s poisons are being given the Covaxin trial shots without their knowledge or consent”.
“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,” she added.
According to another resident, after the issue was highlighted in the media, those who participated in the trial were told not to speak to the press.
One trial participant died
One trial participant — Deepak Maravi, a 45-year-old daily wage labourer — died in the days following the first shot. His autopsy showed that he died of cardio-respiratory failure as a result of suspected poisoning.
Bharat Biotech said in a statement that the “serious adverse reaction” had been investigated but not found related to the “vaccine or placebo”.
Speaking to ThePrint, Deepak’s widow Vaijayanti said “police were asking my youngest child whether we had poisoned him”. “He (Deepak) had not eaten for two days, so the question of poisoning doesn’t arise,” she added.
Maravi died on 21 December, less than 10 days after he got the shot, and the university was immediately informed. He was supposed to get the second shot on 8 January. That day, one of his sons received a call from the university to invite Maravi for the second round of vaccination — an incident the university admits was the result of a “lapse” on their part.
Vaijayanti said she had no idea her husband had participated in the trial.
“They were paying Rs 750 per shot and my husband thought it was a good way to earn some more money. He did not inform me about it but told my youngest son he had taken the injection,” said Vaijayanti. “He told him not to tell me as I would not have allowed it.
According to Vaijayanti, on 12 December, “he went for work and came back around 5-6 pm”.
“He did all his work and even washed his clothes. But the next day, he said he won’t go for work and started complaining about pain in his right arm. We told him to go to the doctor but he said he would be fine soon,” she added. “From 19-20 December, he stopped eating and could not even go to the washroom on his own. On the 21st, foam began to come out of his mouth and his arm turned bluish. Both my sons rushed him to hospital where he was declared dead,” she said.
The family wants the administration to conduct an inquiry into the matter.
‘We gave all the information’
A.K. Dixit, dean of the People’s College of Medical Sciences & Research Centre, denied the allegations that have been levelled at the institution, saying they follow all rules and regulations and are working for the nation.
Talking about the Deepak Maravi case, Dixit said they were in touch with him for seven days after the shot and he did not report any problems. However, he added that if any lapses are found, the ethics committee will be provided all the details and it will take a decision in the matter.
“On 22 December, we gave all the information regarding Deepak Maravi to Bharat Biotech and the government,” said Dixit.
Since the Covid vaccination trial is a double-blind study, it is not yet known whether Maravi received the actual shot or a placebo.
“We have spoken to Bharat Biotech who said the IV will be decoded only after the trial is complete. Only during special circumstances can we do it,” Dixit said.
Referring to the call that went to the Maravi household on 8 January, Dixit admitted it was a “lapse”. “There has been a lapse. We monitor it on two fronts. There is one main team, which sends messages and follows up on telephone, but the second team on the reception did not get the information and they made the call,” he said.
Asked about the other allegations, that participants were misled about the nature of the exercise, Dixit denied them.
“About 20-25 per cent of those who came were illiterate and gave thumb impressions. Before they gave the thumb impression, the counsellor gave them all the information in English and, in case they could not understand English, in Hindi,” he said.
“Only when they understood what it was for and gave their consent did we include them in the trial. There is not a single case where consent was not taken. I don’t know how you are claiming that they were not informed. We followed all rules.”
Questioned about the participation of gas tragedy victims, he said, “As far as the issue of gas victims is concerned, we have been asked to cover a radius of 4 kilometres and these communities are living in the neighbourhood of People’s University. But there are an inclusion and exclusion criteria that is being followed.”