Locals who recalled hearing it back in December said they scrambled to take up the offer — 750 rupees was about twice what they’d usually earn for a day’s hard labor. And many had struggled to work at all during the pandemic.
“They told us it is the corona vaccine and we should get it so that we don’t fall sick,” said Yashoda Bai Yadav, a housewife from Bhopal who participated in the trial alongside her husband.
The Shankar Nagar slum — where many of the participants live — is just 3.7km (2.3 miles) from the abandoned Union Carbide factory which was at the center of the 1984 disaster that exposed more than half a million people to a toxic gas cloud. Nearly 4,000 people died in the immediate aftermath, and the disaster was blamed for at least 10,000 subsequent deaths, and more than 100,000 permanent injuries.
Decades later, many residents still suffer related health issues, raising questions from local non-governmental organizations about residents’ suitability to take part in a study that vaccine developer Bharat Biotech has called the biggest Phase 3 vaccine trial ever conducted in India.
Phase 3 trials are traditionally the final step of human trials before a vaccine is authorized to roll out en masse. However, Covaxin was approved by the Drugs Controller General of India for restricted emergency use in January, before preliminary results from the trial were released. Its Phase 3 trial isn’t expected to be completed until next year. The government has procured 5.5 million doses of Covaxin and 11 million doses of Covishield — the local name for the Oxford-AstraZeneca vaccine — for the first phase of what it is calling the largest immunization drive in the world.
At least two bioethics experts, one public health expert and four local non-governmental organizations, have raised ethical questions about the trial site in Bhopal, run by People’s Hospital, which is associated with the People’s College of Medical Sciences and Research Centre. In addition, those concerns were also raised in a joint statement released on January 14 by more than 40 organizations and 180 individuals, including public health activists and bioethicists.
More than a dozen Bhopal trial participants told CNN they did not know they were taking part in a clinical trial. Another four knew they were part of a trial, but say they did not understand what that meant.
Bharat Biotech, ICMR and People’s Hospital have all denied wrongdoing. They say that the trial complied with study protocol, guidelines and regulatory provisions, and that they are focused on generating high quality data and would not do anything that compromises patient safety. They say that participants gave informed consent and denied that the money offered acted as an incentive. India’s drug regulator, the country’s health ministry, and the ethical committee overseeing the trial in Bhopal have not commented on the allegations.
But Jesani, Dr. Anant Bhan, a Bhopal-based bioethics expert, and Amulya Nidhi, a public health expert and the co-convener of the People’s Health Movement India, all say that the alleged recruitment process, if proven true, would be a violation of Indian protocols governing how vaccine trials should be conducted.