A vial labelled with Bharat Biotech’s ‘Covaxin’. Photo: bharatbiotech.com
New Delhi: On July 2, researchers at Bharat Biotech uploaded the long-awaited scientific paper describing the results of the phase 3 clinical trials of the company’s COVID-19 vaccine, called Covaxin. But while the paper filled multiple gaps in what we do and don’t know about Covaxin, including the statistical significance of the trial’s various results, it has still overlooked one significant detail that has threatened to undermine the trial’s integrity.
In December 2020, People’s Hospital in Bhopal – one of the two dozen or so sites of the multi-centre Covaxin phase 3 trial – recruited a group of people from a poorer locality in the city, but didn’t inform them that they were participants in a trial. Instead, they were led to believe that they would be receiving COVID-19 vaccines for free and given Rs 750 each, and agreed to be involved. They weren’t informed of their participation’s potential pros and cons – as the participants of all trials need to be – nor were they entitled to follow-up treatment in case they fell ill during the trial.
Science journalist Priyanka Pulla had flagged the oversight on Twitter on July 3.
Update, July 6, 2021, 9:51 am: medRxiv, the name of the repository hosting the Covaxin phase 3 paper, published a longer comment by Pulla describing these issues in the paper and its failure to address them.
Bharat Biotech’s new paper describing the Covaxin results doesn’t mention the People’s Hospital episode, nor discusses whether it excluded this group of participants from the final analysis, considering the hospital didn’t follow the necessary protocols with the group. Failure to abide by these protocols have multiple implications for the trial.
First, this group’s consent was not informed consent, but based on the belief that its members were not participating in a trial. Second, each participant from this group was paid Rs 750. Most of them worked for daily wages, and Anoo Bhuyan reported that Rs 750 amounted to two days’ wages for many of them. As a result, the fee – reportedly approved by the institutional ethics committee of People’s Hospital – became a strong source of bias, potentially inducing the participants to act against their better judgment.
Also read: How Do You Catch Mistakes in a Clinical Trial? An Ethics Expert Explains.
Third, these participants were not entitled to the free medical care that every trial’s sponsor – in this case Bharat Biotech – is obligated to provide those who take ill during the trial. In at least one instance, one vaccine recipient was asked to foot a bill of Rs 450 for diagnostic tests in response to a fever he developed. Fourth (and on a related note), the hospital couldn’t contact at least one person who had mild side-effects after the first dose, a carpenter named Jai Ram, and didn’t register his symptoms ahead of the vaccine’s safety analysis. The controversy surrounding another person’s death following vaccination is yet to be resolved.
Overall, multiple experts have said that the data pertaining to People’s Hospital should ideally be left out of the final analysis. People’s Hospital is one of 26 sites in the trial. Excluding the 1,700 participants who enrolled at this site – the largest number at a single site in the trial – will mean the trial’s administrators will have to perform their analyses anew.
The experts, and other stakeholders, have also demanded that the Indian Council of Medical Research (ICMR), which has been helping Bharat Biotech develop Covaxin, and the company do right by the participants whom the hospital misled.
But when multiple outlets reported these allegations in January 2021, both ICMR and Bharat Biotech denied them. Both ICMR chief Dr Balram Bhargava and the company’s spokespersons maintained the same line: that they had followed all protocols as laid down by the New Drugs and Clinical Trial (NDCT) Rules 2019.
Neither offered any explanation or evidence to refute specific allegations – including statements by the participants that indicated the NDCT Rules hadn’t been followed. For example, ICMR has flatly claimed that the hospital didn’t breach ethical norms. But the hospital-university’s vice-chancellor had admitted that the participants were not given a copy of their consent forms to take home, which is a straightforward breach.
Pulla also reported for The Quint in February 2021 that if only one or two persons had slipped through the hospital’s trial surveillance, “the data would still largely be reliable. But too many participants have described [similar] experiences [to the person who slipped through], pointing to a badly-done trial and large chunks of missing data. While some … didn’t get any of the seven phone calls (either after the first or second shot), others whom The Quint spoke to said they received only one or two.”
Also read: Bhopal Hospital’s Serious Breach of Covaxin Trial Protocols Could Prove Costly
The People’s Hospital incident has also been important from a rights perspective. Many of the affected participants were survivors, or descendants of survivors, of the 1984 Bhopal gas tragedy – an already socially disenfranchised community that hasn’t received due compensation for its injuries. Bhuyan also reported, for IndiaSpend, that around the time a truck from the hospital rolled into the locality with a loudspeaker, many men had been unemployed and their children out of school for a year, thanks to the pandemic.
It was also yet another instance of state-supported antipathy against the poor during the pandemic. The biggest example of this attitude was the Narendra Modi government’s failure to plan for migrant workers, ahead of imposing the first lockdown in March 2020. Many of the affected participants found out about the hospital’s transgressions before their second doses, and didn’t return. Overall, in the Covaxin phase 3 trial, 1,379 participants dropped out of the trial, according to Bharat Biotech’s paper.
Researchers Anurag Mehra and Anshu Deshmukh recently wrote for The Wire Science about how such attitudes and actions encourage vaccine hesitancy among the poor and illiterate.