Bhopal: Suspicions about the credibility of Covaxin from Bharat Biotech [one of the two COVID-19 vaccines approved for emergency use in India] prevails after news of the death of Deepak Marawi, 45, a worker from Bhopal, who received the first injection of the vaccine at the People’s Hospital in the state capital on December 12.
On December 21, Marawi’s son, Suraj, 24, rushed him to Gandhi Medical College and Hospital (GMCH) after he started vomiting constantly and his mouth was puffed up. But, he was pronounced dead hours after his arrival.
A resident of Teela Jamalpura, Marawi was one of 1,750 people who received Covaxin as part of the ongoing Phase 3 trial. Relatives of Marawi claimed that since he was a laborer and struggling to find a job, he had been vaccinated and returned home with fruits and vegetables.
“He secretly vaccinated himself and only spelled the secret out to my younger brother and asked him not to tell anyone,” his eldest son Suraj said. “He had been bedridden ever since, complaining of muscle pain and cramps, vomiting and stomach pain.
The reason for Marawi’s death, as mentioned in the post-mortem report carried out at GMCH by Dr Gita Rani Gupta, is cardiac respiratory failure resulting from suspected poisoning. The viscera were stored for chemical analysis in common salt, the postmortem report indicates. The People’s Hospital administration said he had been sent to the regional forensic laboratory and his report should arrive within a month. In addition, they claimed to have sent his death report to the Institutional Ethics Committee, the Central Medicines Standards Control Organization and the Data Security Oversight Committee, as required by law.
Meanwhile, Marawi’s relatives alleged that hours after his death, they received a call from the People’s Hospital and two people from the hospital met with the GMCH doctor. [who was scheduled to conduct his postmortem] behind closed doors for hours.
On the other hand, the administration of the People’s Hospital said that only Bharat Biotech will be able to determine whether Marawi received a vaccine injection or a placebo. Following the controversy, Bharat Biotech, in a statement, said that “the serious adverse reaction had been fully investigated and was not found to be related to the vaccine or the placebo”.
He added that he could not confirm whether Marawi received the vaccine or the placebo since it was a double-blind study. He added that the volunteer, at the time of enrollment, had “met all inclusion and exclusion criteria” and was in good health in all “on-site follow-up calls after seven days of treatment. “.
“There are several factors that can cause an adverse event during a clinical trial, including the patient’s underlying disease, other pre-existing conditions, or any other unrelated event such as an accident,” the statement said.
An expert group of GMCH doctors formed by the state government to look into the failings in the ongoing trial at the People’s Hospital have given the hospital a blow.
Contacted, People’s Hospital Dean AK Dixit said that according to the rules set by New Drugs and Clinical Trials 2019, the death was reported to relevant authorities two days after Marawi’s death.
“Marawi had not reported any health problems for seven days after the administration of Covaxin, according to our records. All procedures were properly followed and duly signed by him, ”said Dean AK Dixit.
“The report on the viscera will only establish the real reason for his death,” he added.
When asked why the hospital had not informed the media of his death even two weeks after the incident, Dixit replied: “By law, we were asked to send the report to three agencies. within two / three days of the incident and we followed it up. There is no question of placing the information in the public domain. “
Rachna Dhingra, a social activist working for gas victims in Bhopal, claimed that 70-80% of people who took part in Covaxin’s phase 3 trial were from a marginalized class who were barely able to sign papers . “They were drawn to money because they were struggling financially,” she said.
“Dozens of people have been reported ill after receiving the first injection of Covaxin. Those who approached the hospital for help were arrested, ”Dhingra said.
“There is a flagrant violation of the protocols established by the ICMR for the conduct of a trial. The participants were barely informed of the trial, no consent form was given to them, ”she added.
Poor participants selected for the trial: the activists
Days before Marawi’s death, NewsClick had visited settlements of those involved in the trial. They claimed that a vehicle going through the narrow lanes of Shankar Nagar, Timer market, Udiya Basti, Garib Nagar, JP Nagar and Shiv Shakti Nagar (mainly resident areas affected by gas) and provided free treatment for colds, cough and arthritis with various tests performed. free at the nearby people’s hospital.
They were also offering Rs 750 for this, they claimed.
“Since the hospital was offering 750 rupees, almost the same as their two-day salary, locals rushed to the hospital,” said Nasreen, working for the gas victims. “At the hospital, they were told it was part of a trial, but they weren’t sure what medication was being given to them. But they were assured that it would cause no side effects and that if it did, they could go to the hospital. After the vaccination, they received a diary to report their health problems.
The phase III trial of Covaxin began in Bhopal the last week of November at the People’s Hospital where 1,750 volunteers received the first and second injections of the vaccine. The indigenous Covaxin vaccine was developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR).
When contacted, AK Dixit, dean of the People’s Hospital, which is overseeing the trial, dismissed the claim that he had sent a vehicle to the settlements and lured people in with free health checks and promising money.
‘I got the vaccine for money,’ participants say
A day after news of Maravi’s death was heard, NewsClick went to the People’s Hospital on Saturday and spoke to scores of people who were taking the second dose of Covaxin as part of phase three of the trials.
Many claimed they were unemployed and participated in the trial for money, while many claimed to have been told that free Covid-19 vaccines were being administered.
Many like Ramesh *, 28, (name changed), who works in a factory, were present for the second dose, ignoring the death of a test volunteer and the irregularities reported by the media. “We were told it was like vaccines given to children and as many were coming, even I entered. We were given 750 Rs which is way more than the 200 Rs I earn each day, ”said Ramesh, who is a resident of the Chola region.
Two other participants, Amol * and Manish *, residents of JP Nagar, claimed they were unemployed and took the blow for money. “I took the picture and bought a bottle of rum with the money they gave me and threw a party,” Amol said.
But, according to hospital authorities, all those participating in the trial were counseled and their consent was taken on paper, while audio-visual consent of those over 60 was recorded.
The People’s Hospital registered the highest number of 1,750 volunteers who showed up to participate in the trial where a minimum of 1,000 was required. However, the number of those coming for the second dose has steadily declined by 5-10%, the hospital administration said.
During a video conference with journalists, NGOs working with Gas-hit victims demanded that the trial be stopped until the final report on Marawi’s death is made public. Shehzadi Bee of Bhopal Gas Peedit Mahila Purush Sangharsh Morcha called for punishment for all responsible parties who neglected to ensure the safety, welfare and rights of trial participants.
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