On Saturday, January 10th, the four major survivor organisations in Bhopal wrote a letter to Indian Prime Minister Narendra Modhi and the Health Department requesting the immediate end to a trial of the drug Covaxin at a Bhopal hospital, citing potential exploitation of gas survivors, one of whom died nine died after receiving the vaccine.
The trial of Covaxin, a new Covid-19 vaccination from Hyderabad-based company Bharat Biotech, was held at Bhopal People’s Hospital in December. Concerns about the trial have arisen following allegations that poor and vulnerable people, including more than 700 survivors of the Bhopal gas disaster, were lured into taking part in the trial with the promise of RS. 750 (£7.49) and a vaccine for coronavirus, without access to full information of the potential health risks involved in the drug trial.
Bharat Biotech have since claimed that the RS. 750 offered to participants was offered as compensation for travel expenses and loss of daily earnings and not payment for participation in the trial, in line with the stipulation by the Indian Council of Medical Research that participation in drug trials should be voluntary and should not involve the offer of monetary compensation or rewards. However, a number of participants, including multiple gas survivors, have since come forward claiming that they were not properly informed of the potential dangers of participation in the trial, or that they may receive a placebo rather than a dose of Covaxin.
As is standard in trials of new drugs and pharmaceuticals, participants were enrolled in a ‘blind study’, in which a treatment group receive the drug while a control group receive a placebo, allowing staff to better monitor the effectiveness of the drug. Trial guidelines from the ICMR also clearly state that participants should be informed of this fact before agreeing to take part, as well as all potential dangers and side effects involved in the study.
Although consent forms and information sheets were allegedly issued to all participants in the trial, the letter from the four Bhopal survivor organisations states that many participants did not receive or failed to sign a consent form, while others did not or could not read the information sheet, the Hindi version of which apparently carried a disclaimer stating that the sheet may contain ‘technical language that is beyond the comprehension of any layperson, let alone persons with minimal education’.
In the event that participants were not properly informed of the nature or dangers of the trial, the fact that that the money was not being offered as payment for participation, or were lead to believe that they were due to a receive a fully tested vaccine for Covid-19, Bharat Biotech could potentially be facing charges of entrapment. Aside from concerns about the basis for participation, survivor groups claim that as many as 700 of the 1,700 participants in the trial were gas survivors, many of whom suffer from underlying health conditions as a result of their exposure that could potentially effect their susceptibility to drugs and other treatments.
On January 10th it was reported in multiple Indian news outlets that one participant in the trial, a 45-year old gas survivor, had died on December 21st, 9 days after his involvement in the Covaxin trial at People’s Hospital. Following a post-mortem, in which it was determined the man died from cardio-respiratory failure, Bharat Biotech issued a statement on Saturday claiming that the individual’s death was not due to his involvement in the trial, but could not say whether he received a dose of the drug or the placebo due to the blind nature of the study. Survivor groups claim that full information surrounding the man’s death has not been made available, nor has his family received a copy of the consent form he signed before participating.
We await the Indian Government’s response to the letter from the four survivor organisations, we well as the full results of the investigation into the death of survivor who participated. In the meantime, as of January third, Covaxin has been approved by the Indian Government for emergency use against Covid-19.
If you would like to read more about this story, you can fine links to media coverage from the Indian press at the links below: