Several persons in Bhopal who had volunteered for Bharat Biotech’s ongoing trial of Covaxin , one of the two COVID vaccine candidates approved in India, alleged that the medical managers of the trial didn’t inform them that they were test subjects.
Speaking at an online press conference on Sunday, the volunteers said they were led to believe that they were getting vaccines as part of a government vaccination drive and were also promised ₹750 each for participating.
The trial is being conducted at the People’s Medical College (PMC), where on Friday there were reports that a 42-year-old volunteer, who had been part of the trial, had died. His post mortem report, however, said the cause of death was “cardiorespiratory failure due to suspected poisoning.” On Saturday, Bharat Biotech denied that his death was due to the vaccine. It is not known whether he got the vaccine or a placebo.
Covaxin, an inactivated Sars Cov-2 virus, repurposed as a vaccine, is being tested in 28,500 volunteers across the country.
At the PMC, 1,700 persons were recruited in the trial between November 28 and December 31. The trial was planned as a double blind, placebo controlled trial in which some participants got the actual vaccine and some a dummy shot. Neither the trial organisers nor the volunteers are supposed to know if a person is in the placebo group or the vaccinated group. This is done to calculate how effective the vaccine is in preventing people from catching COVID-19.
Bharat Biotech has, however, had significant challenges in recruiting people to participate in the trial. Inspite of no efficacy data, Covaxin was approved on January 3 in clinical trial mode, meaning that volunteers would have to give informed consent and be followed up.
However, as part of the government’s vaccination drive, every eligible healthcare worker will get the actual vaccine.
Bharat Biotech claimed last week that it had finished recruiting all of the intended participants but it isn’t clear how many have got one dose of the vaccine and how many intended to show up for the necessary second dose after four weeks.
Mr. Mansingh Parihar, 70, a mason, said at the press conference that he wasn't made aware of the nature of the trial and though he signed consent forms, he did not understand them fully.
Describing his experience, Mr. Parihar said: “I had no illnesses. I was fine for two days after I got one shot but then fell very sick and was acutely breathless.”
He said he wasn't aware that he could contact the hospital and the Principal Investigator — the doctor who manages the trial — for treatment.
“I'm not going back again (for a second shot). I only signed up because I was promised ₹750 and free vaccination,” he said.
Another volunteer, Chandan Devi, 60, who’s also a Bhopal gas tragedy survivor, said she, too, had signed up because of the money offered and the belief that the “Corona injection” would protect her from the disease. “I had nausea and my head was spinning, after two days [following the injection],” she said.
In a letter to the Prime Minister and Union Health Minister sent this morning, Bhopal-based organisations have also sought punishment for those “negligent” in ensuring the safety of the trials and compensation for those affected.
Activists have meanwhile demanded that the trial be stopped.
Rachna Dhingra of the Bhopal Group for Information & Action said, “People whose health is compromised due to 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. Trial participants who leave or are excluded halfway are denied care and are not followed up.”
Rashida Bee, President of the Bhopal Gas Peedit Mahila Stationery Karmchari Sangh said in a statement, “At least 700 of the 1,700 people on whom this vaccine, with unknown efficacy, is being tested, are people poisoned by Union Carbide. One gas victim has already died within 10 days of getting the trial shot and many continue to have health complaints of serious nature. No one has been punished for the death of 13 gas victims who died during trials by pharma companies at the Bhopal Memorial Hospital & Research Centre some twelve years back. We are writing to the Prime Minister to ensure there is no repeat.”
Till the time of going to press, Bharat Biotech has not responded to The Hindu’s efforts for a response to the allegations.