The TLDR: A daily wage worker in Bhopal died last month after he received the first jab—as part of its Stage 3 trials. Bharat Biotech insists that it is unrelated to its vaccine. But the death has raised serious questions about how the company recruits its volunteers—and who it targets, i.e. poor, illiterate Indians who sign up without information or proper consent. 

PS: We’ve done a series of explainers on Covaxin and the problems with its trial data here and here.

 Tell me about this death

• Deepak Marawi was a 45-year-old daily wage worker—and one of 1750 participants in a Covaxin Stage 3 trial conducted in Bhopal.
• He became severely ill, suffering bouts of “incessant vomiting and frothing.” He died on December 21—nine days after he received the first of the two-jab regimen. 
• According to the newly-released post-mortem report, Marawi died of “cardiac respiratory failure as a result of suspected poisoning.”
• It found no link between his death and the vaccine—a point strongly underlined by Bharat Biotech which said the ‘serious adverse event’ has been “thoroughly investigated.”

Point to note: This is a double blind study—i.e. neither doctor nor the participant know if they’ve received the vaccine or the placebo. And Bharat Biotech says it doesn’t know what Marawi received. And that has raised eyebrows, with experts asking: “How can they keep a participant who has died blinded and yet claim the death is not related to the trial?” Also this: Some experts say that a routine post-mortem is not sufficient, and trial linked investigation requires “pathology analysis.”

Maybe it wasn’t the vaccine… why is this a problem?

Irrespective of the cause of death, it’s becoming increasingly clear that Bharat Biotech is dangerously cutting corners as it rushes to complete its Stage 3 trial—and doing so at the expense of its carefully chosen volunteers.

Who is recruited? In Bhopal, the company targeted poor communities who live behind the old Union Carbide factory (read about the 1984 gas tragedy here). Most of them are poor and illiterate—and many are survivors of the gas leak. The company lured the residents with the promise of Rs 750 (a huge amount for these workers) and free transportation. As one local activist notes: “They have gone to low-income areas and mass-canvassed for vaccination.”

Why the poor? Bharat Biotech has struggled to recruit volunteers for its stage 3 trials. As of December 22, it had only signed up 13,000. In bigger cities like Delhi, people just refused to participate—especially once they were told that at least 50% would receive the placebo. And yet in Bangalore, hospitals are urging people to sign up by emphasizing the efficacy of the vaccine. But it doesn’t seem to have worked.

Reframing the pitch: Given the above, it becomes clear why the company went after less affluent and less educated Indians—who were given a revised pitch. Late last month, The Print accessed a document created to help recruit volunteers. The list of FAQ includes this key answer:

“One of the FAQs listed is: ‘Why should I participate in the Phase 3 Efficacy Trial for Covaxin and get vaccinated, when the government announced that persons above the age of 50 years will be vaccinated shortly?’

 

In response, the document states, principal investigators should tell recruits that the vaccine will protect them against Covid-19. The Hyderabad-based firm also wants recruits aged over 50 to be told that it is ‘advisable’ for them to participate in the trial since it may take months for the government to reach them even if they are identified as a priority group.”

Key point to note: There is no evidence that Covaxin offers any protection—the Stage 3 trials are supposed to determine efficacy. Also: since 50% receive a placebo, there is no way to guarantee that participating in a trial will offer any protection against the virus.

Volunteer testimony: The level of misinformation became even clearer when reporters spoke to volunteers. A balloon maker in Bhopal told Indian Express: “We were told it is like 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.” Here’s another example from Bhopal in this clip:

But they’ve freely signed up for this, right? 

According to the law, each participant must give their freely given, informed, written consent. They must be informed of every aspect of the trial process in non-technical language. Also this:

“The rules point out that if the trial subject, or his or her legally acceptable representative is unable to read or write, an impartial witness should be present during the entire informed consent process who must then sign the consent form.”

Multiple media reports make clear that participants did not sign any consent form before signing up for the trial. Others signed some documents but did not receive a copy--even though the company and hospitals insist they have signed forms for all their participants. For example, Jitendra Narwariya:

“Several of us registered for the injection. They assured that the injection would help us. I did not understand that they were testing the vaccine on us. They did a few more tests on us there. They gave us a few papers to fill, but I did not know how to fill it.”

Worse, if some of the participants fell ill after the first dose, they were arbitrarily kicked out of the trial, like sixty year old Manju Bai:

“I was not given the second injection. They took away the papers that I had with me. They said that I do not need to keep the papers with me. I was told I do not need to come back for any more injections.”

Or take the case of 40-year old Sangeeta Jaiswal:

“‘We were told it is a vaccine that will protect us from corona. We were not informed about any trial.’... Jaiswal told me that neither was she able to read the form, nor did someone verbally explain what was written in the consent form to her. ‘They didn’t give us a copy of the form I signed. They gave us another sheet of paper along with some empty sheets of paper. They asked us to write on the sheets in case we develop a headache or weakness.’”

The bottomline: When asked, most doctors say they will pick Serum Institute’s version of the Oxford vaccine over Covaxin. But over the coming months—as the government rolls out its mass vaccine campaign—will poorer Indians have the same choice?

Reading list

Indian Express has the most details on death, while The Telegraph looks at ethical issues with the way it was handled. The Caravan has an excellent report on the absence of consent but it's behind a paywall. Just as good on the subject: This National Herald story. The Print has the exclusive on the company FAQ to recruit volunteers.