A healthcare worker holds up a vial of Bharat Biotech’s Covaxin. Photo: PTI
New Delhi: A report by Priyanka Pulla on The Quint has found that that the same Bhopal hospital that had earlier been reported as having committed ethical breaches during COVID-19 vaccine trials has also violated the protocols set down by Bharat Biotech for phase 3 trials of its Covaxin candidate vaccine.
In addition to already reported violations of the New Drug and Clinical Trial Rules 2019 (NDCT 2019), the People’s Hospital also violated these protocols to a degree that renders data from this section of trials “untrustworthy,” notes Pulla.
The hospital is one among 26 trial sites for Covaxin and had signed on more than 1,700 participants. The protocol violation also jeopardises Bharat Biotech’s understanding of the efficacy and safety of its COVID-19 vaccine.
The report cites examples of trial participants who said on record that the hospital did not take down symptoms of illnesses they suffered immediately after taking the vaccine.
Worryingly, the report quotes responses from Bharat Biotech and the Indian Council of Medical Research (ICMR), the two sponsors of the trial, entirely brushing off the incidents.
Their insistence that due process was followed with regards to adherence to procedures laid down by the Drug Controller General of India, recording and reporting of adverse events following immunisation points to a bigger flaw that shirking of ethical responsibility.
Also read: Vaccine: Bhopal Patients Say ‘Weren’t Given Consent Forms or Told It Was a Trial’
“…by claiming there were no violations at all, they are implying that they plan to use data from People’s Hospital as-is in the calculation of the vaccine’s efficacy and safety,” Pulla notes.
The report breaks down the protocol laid down by Bharat Biotech and exactly where the trials deviated from them in great detail. However, one of the key points it highlights in the protocol is Bharat Biotech’s promise to note the “rates of solicited adverse events, unsolicited adverse events, serious adverse events, and the occurrence of so-called Vaccine Associated Enhanced Respiratory Disease (VAERD).”
Solicited adverse events
Soliciting or asking participants for information on various parameters would help Bharat Biotech arrive at a conclusion as to whether the vaccine itself was responsible for causing the various adverse events.
The trial team at People’s Hospital was thus supposed to “telephone every participant for seven days after the first and second injections. In addition, each participant was given a daily diary to fill.”
In addition, detailed grading systems for adverse events would facilitate good record keeping and thorough understanding of the degree to which who was suffering from what effect.
Another goal of the trial was to capture cases of COVID-19 among participants throughout the yearlong trial period. This, naturally, required aggressive follow up and participants’ access to trial conductors.
However, Pulla’s report says that participants’ accounts reflect an “extremely chaotic” process of data collection.
“Not only did the trial team fail to contact several participants at the pre-defined times, they also sometimes drove away participants who reported sick to the hospital. Both actions are the opposite of what the protocol demands,” the report says.
The report sites the example of 70-year old Man Singh Parihar, a construction worker, whose ancestors survived the Bhopal gas tragedy and was a participant in the trial. He made his way to the hospital with COVID-19 like symptoms a whole 16 days after first exhibiting them. No one from the hospital called him and he could not fill the diary as he cannot read or write.
The 24-hour window is important for trial participants to note down their symptoms as experts say that we are often unable to recall situations to the desired level of detail beyond that period.
“If it was only Man Singh Parihar who slipped through the trial’s surveillance net, and the study team collected data scrupulously from the 1700+ other participants, the data would still largely be reliable,” notes Pulla.
Also read: How Covaxin Trial Participants in Bhopal Were Misled
However, some 223 participants were identified by activist Ruchira Dhingra as having experiences some protocol violation or the other.
The case of Jitendra Narwariya, too, is cited in the report. As The Wire Science had noted earlier, Narwariya was reportedly compelled to shell out money for medicines after participating in the trial and contracting diseases.
Serious adverse events
People’s Hospital’s investigation into the death of Deepak Marawi, a 45-year old participant, has raised troubling question too, notes Pulla in the report.
Serious adverse events are those that lead to deaths or hospitalisation and require lengthy medical investigation. But People’s Hospital was quick to conclude that Marawi had been poisoned and his death was unlikely to have been related to the vaccine.
The hospital’s claims of routine follow up are refuted by his family, who were never interviewed by investigators, who have alleged that he grew systematically weaker in the days following the shot.
Ultimately, Pulla notes that when the hospital recruited so many vulnerable participants – that is, those who did not know how to read or write or did not have phones that could facilitate communication – the principal investigator and the ethics committee ought to have intensified their efforts to counsel participants and follow them up.
There was neither adherence to Good Clinical Practice (GCP), a set of standard practices aimed at ensuring data integrity and the protection of trial participants, and nor was there essential adherence to the NDCT, 2019, and National Ethical Guidelines for Biomedical and Health Research Involving Human Participants.
“Bharat Biotech’s trial in Bhopal was being overseen by multiple bodies, including the ethics committee, clinical trial monitor IQVIA, and an independent data and safety monitoring committee (DSMB),” the report notes, concluding that the silence of all such bodies on this matter makes little sense in the face of such obviousness of the breach.