Unethical practices and violations alleged, including misguiding village folk into taking test and not taking their consent; Bharat Biotech has denied inducement.
While India prepares for its massive vaccine roll-out, a group of activists involved with the Bhopal gas tragedy wrote to Indian Prime Minister Narendra Modi and Indian Health Minister Dr Harsh Vardhan alleging unethical practices and serious violations in the Phase-3 clinical trials conducted at the city’s Peoples College of Medical Sciences & Research Centre to test the safety, immunogenicity, and efficacy of Covaxin. Covaxin is the Covid-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). It was recently authorized for emergency use on a clinical trial mode by the Indian drug regulators and has also attracted serious concerns and criticism on its implication.
The letter said: “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.”
Specifically, the letter alleges, people who took the trial from the communities that were affected by the Bhopal’s Union Carbide gas tragedy were “vulnerable people [were] being misguided and herded” by the investigators at trial sites without explaining the norms for proper, informed consent from prospective volunteers. Reports have also indicated a lack of proper monitoring and follow-ups and people who experienced adverse reactions have not received medical services.
The letter urged the government to immediately intervene and stop the trial at Bhopal and conduct an independent and time-bound evaluation into the violations and transparency in the details of the probe.
News channel NDTV reported on Tuesday that many participants of the vaccine trial in Bhopal have alleged that they were administered shots without consent. The hospital allegedly approached the residents and offered Rs 750 ($10.24) for a jab.
The activist group also held a press conference Sunday where the participants from communities situated behind the abandoned Union Carbide factory—the site of the Bhopal Gas tragedy gave their accounts on how the trial was conducted. All of them stated that they were told that the vaccine will save them from coronavirus, the government was administering it for free, and they would receive Rs 750 for every shot taken. However, none of them were informed it was a clinical trial and the vaccine is being tested on them to observe its effectiveness.
Bharat Biotech in a statement said that the Covaxin Phase 3 study is being conducted across 26 sites in India in compliance with the study protocol, Indian good clinical practice guidelines, and all regulatory provisions that apply to clinical trials in the country. It also said that the decision of every site’s institutional ethics committee approved to reimburse all participants at the rate of Rs 750 for each study visit was not an inducement.
The company said: “Our constant focus during the development of the vaccine and the clinical trials has been on ensuring patient safety and ensuring that the study is done to the requirements of all the relevant and applicable rules and guidelines and that the data generated is of the highest quality and valid.”
A 42-year-old man from Bhopal who took the vaccination on December 12, died nine days later.
The deceased’s family claimed that it was due to the vaccine, and medical experts have viewed the death with concerns of poisoning, but Bharath Biotech denied the claims.
The letter is signed on behalf of the survivors of the Union Carbide disaster in Bhopal by:
- Bhopal Gas Peedit Mahila Stationery Karmchari Sangh
- Bhopal Gas Peedit Mahila Purush Sangharsh Morcha
- Bhopal Group for Information Action
- Children Against Dow Carbide
Click here for the letter.