Bhopal event cast a shadow over Bharat Bio | Economic Times

New Delhi: Jitendra Narwariya was administered Bharat Biotech’s vaccine candidate Covaxin on December 10 at People’s College of Medical Sciences & Research in Bhopal as part of the company’s phase-3 trials. A few days later, he had fever, weakness and lack of appetite. He has not gone back to work since December 14 because of his deteriorated health conditions, his mother Gulab Bai said on Sunday. Like several others, Narwariya had heard about Covaxin through announcements from a moving vehicle that announced that they would get Rs 750 and an injection that would protect them against Covid-19. Narwaiya is one of the participants of Covaxin trial who along with others have written to the prime minister to stop the trial. On December 21 a participant reportedly died. While Bharat Biotech and ICMR did not respond to ET’s email, Bharat Biotech in a statement issued on Saturday had said that the death of the 42-year-old man in Bhopal who participated in the trial was not related to the vaccine. “The volunteer passed away nine days after the dosing and preliminary reviews by the site indicate that the death is unrelated to the study dosing. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded”.“This SAE (serious adverse event) has been thoroughly investigated and has not been found related to vaccine or placebo. All data and reports on this SAE has been submitted to the site ethics committee, CDSCO and DSMB (Data and Safety Monitoring Board)”.The participants said that the recruitment started early December and 1,700 odd people were recruited. Seventy-year-old Man Singh Parihar is another participant. He got his first shot on December 21. But two days later he felt a loss of appetite, running nose, headache. Parihar is convinced that he is not going to get the second shot. Many of these participants are people from communities affected by the Union Carbide gas disaster in Bhopal . Health activists call it a “violation of ethical procedures”. “Some of these individuals have faced adverse events since dosing in the trial, and even a death has taken place,” said Rachna Dhingra from Bhopal Group for Information and Action. “Evidence has emerged that the trial in Bhopal is being conducted in gross violation of laws and guidelines governing clinical trials in India. This is leading to exploitation and harm to a community of people that are not just economically and socially deprived, but whose health is compromised owing to the destructive impact of the Bhopal gas tragedy and its consequences,” she further said. Health activists also alleged that the researchers did not take cognisance of the educational status and economics. They point out violations regarding the consent form. According to them the participants were not given time to read or understand the consent form. Most of the participants are illiterate and audio visual recordings of the informed consent process were also not made. The participants shared that they were not even provided medical management while experiencing adverse events. “I have been facing breathlessness, gastric issues, sleep-related issues ever since I got the injection. Nobody has contacted to check on my well-being,” said 60-year-old Chanda Devi, another participant.