Covaxin Controversy: Death, Enrolment for Payment Allege Volunteers, Authorities Deny

Bhopal: Suspicion surrounding the credibility of Bharat Biotech's Covaxin [one of the two COVID-19 vaccines approved for emergency use in India] prevails after the news of the death of 45-year-old Deepak Marawi, a labourer from Bhopal, who was administered the first shot of the vaccine at People's Hospital in the state capital on December 12.

On December 21, Marawi’s son, Suraj, 24, rushed him to the government-run Gandhi Medical College and Hospital (GMCH) after he began to vomit incessantly and his mouth frothed. But, he was declared dead hours after arrival.

A resident of Teela Jamalpura, Marawi was one of the 1,750 people who were administered Covaxin as part of the ongoing phase-3 trial. Marawi’s kin have alleged that since he was a labourer and was struggling to find a job, he got vaccinated and came home with vegetables and fruits.

“He secretly vaccinated himself and only spelled the secret to my youngest brother and asked him not to tell anyone,” said his eldest son Suraj. “Since then, he was bed-ridden, complaining about muscle pain and cramps, vomiting and stomach pain.”  

The reason for Marawi’s death, as mentioned in the postmortem report conducted at GMCH by Dr. Gita Rani Gupta, is cardiac respiratory failure as a result of suspected poisoning. The viscera has been preserved for chemical analysis in common salt, says the postmortem report. The People’s Hospital administration said that it has been sent to the regional forensic laboratory and its report is expected to arrive in a month's time. Besides, they claimed to have sent his death report to the Institutional Ethics Committee, Central Drugs Standard Control Organization and Data Safety Monitoring Board, as per the law. 

Meanwhile, Marawi’s kin have alleged that hours after his death, they received a call from the People’s Hospital and two persons 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 People’s Hospital administration has stated that only Bharat Biotech will be able to ascertain if Marawi was given a shot of vaccine or placebo. Following the controversy, Bharat Biotech, in a statement, has said that the “serious adverse reaction had been thoroughly investigated and was found not related to vaccine or placebo”.

It further said that it couldn’t confirm if Marawi received the vaccine or the placebo since it was a double-blind study. It added that the volunteer, at the time of enrolment, had “fulfilled all the inclusion and exclusion criteria” and was reported to be healthy in all the “site follow up calls post seven days of dosing”.

“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 occurrence like an accident,” the statement said.

An expert panel of GMCH doctors formed by the state government to look into the lapses in the ongoing trial at People’s Hospital has given a clean chit to the hospital.

When contacted, Dean of People's Hospital, AK Dixit, said that as per the rules laid down by New Drugs and Clinical Trials 2019, the death was reported to the authorities concerned two days after the death of Marawi.

“Marawi hadn’t reported any health issues for seven days after the Covaxin was administered, as per our records. All procedures were appropriately followed and duly signed by him," said Dean AK Dixit.  

“The viscera report will only establish the actual reason of his death,” he added.

When asked why the hospital did not inform the media about his death even two weeks after the incident, Dixit replied, “As per the law, we have been asked to send the report to three agencies within two/three days of the incident and we followed it. There is no mention of putting the information in the public domain.”

Rachna Dhingra, a social activist, working for gas-hit victims in Bhopal, claimed that 70-80% of the people who were made part of the Covaxin phase-3 trial were from marginalised class who hardly were able to sign the papers. “They were being lured with money as they were struggling financially,” she said. 

“Dozens of people have been reported ill after getting the first shot of the Covaxin. Those who approached the hospital for help were shouted at,” Dhingra said.

“There is a gross violation of protocols laid down by the ICMR for conducting a trial. Participants were hardly informed about the trial, no consent forms were given to them,” she added.  

Poor participants picked for trial: Activists

Days before Marawi’s death, NewsClick had visited colonies of those who had participated in the trial. They claimed that a vehicle roaming the narrow bylanes of Shankar Nagar, Timer market, Udiya Basti, Garib Nagar, JP Nagar and Shiv Shakti Nagar (mostly gas-hit resident areas) and assured free treatment for cold, cough, arthritis with various tests done for free at the nearby Peoples’ Hospital. 

They were also offering Rs 750 for it, they claimed.

“Since the hospital was offering Rs 750, almost the same as their two days’ wage, locals rushed to the hospital,” said Nasreen, working for the Gas-hit victims. “At the hospital, they were told that it was part of a trial, but they were not sure of what medicine they were being given. But they were assured that it would not cause any side effects and if in case it does happen, they can reach out to the hospital. After the vaccination, they were given a diary to report their health issues.”

The phase-III trial of Covaxin started in Bhopal in the last week of November at People's Hospital where 1,750 volunteers have been given the first and second shot of the vaccine. The indigenous vaccine Covaxin has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).  

When contacted, AK Dixit, Dean of the People's Hospital, who is supervising the trial, brushed aside the claim of sending any vehicle to the colonies and luring people with free health check-ups and promising money. 

‘Got vaccinated for money’ say participants 

A day after the news of Maravi’s death, NewsClick visited the People's Hospital on Saturday and talked to a slew of people who were taking the second dose of Covaxin as part of the phase three of the trials.

Many claimed that they were jobless and took part in the trial for money, while many claimed that they were informed that free Covid-19 vaccines were being administered.

Many like 28-year-old Ramesh* (name changed), who works in a factory, were present for the second dose, unaware of the death of a trial volunteer and irregularities reported by the media. "We were told it is like the vaccines given to children and since many were coming, even I came in. We were given Rs 750, which is way more than the Rs 200 I make every day," said Ramesh, who is a resident of Chola area.

Two other participants, Amol* and Manish*, residents of JP Nagar, claimed that they were jobless and took the shot for money. “I took the shot and bought a bottle of rum with the money they gave and had a party,” said Amol.

But, according to the hospital authorities, all those who were participating in the trial, were counselled and their consent was taken on paper, while an audio-visual consent of those above 60 years of age was recorded.  

People's Hospital recorded the highest of 1,750 volunteers that came forward to participate in the trial where a minimum of 1,000 were required. However, the numbers of those coming for the second dose steadily fell by 5-10%, claimed the hospital administration.

During a video conference with journalists, the NGOs working with Gas-hit victims have demanded that the trial be stopped until the final report of Marawi’s death is made public. Shehzadi Bee of Bhopal Gas Peedit Mahila Purush Sangharsh Morcha sought punishment for all responsible parties who were negligent in ensuring safety, wellbeing and the rights of the trial participants.

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