Among the 26 trial sites for Covaxin; People’s Hospital, a hospital located in Bhopal which was earlier reported to have committed ethical breaches during COVID-19 vaccine trials has now 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), they’ve now violated protocols to a degree that renders data from this section of trials “untrustworthy,”
People’s hospital had signed on more than 1,700 participants for the trail. Further, the protocol violation jeopardises Bharat Biotech’s efficacy and safety of its COVID-19 vaccine.
There were complains reported by the participants that the hospital did not take down symptoms of illnesses they suffered immediately after taking the vaccine.
The two sponsors, Bharat Biotech and the Indian Council of Medical Research (ICMR) have been brushing off or have been avoiding the incidents that point to a bigger flaw that is of shirking ethical responsibility.
According to reports, People’s Hospital’s investigation into the death of Deepak Marawi, a 45-year old participant, has raised troubling question too. However, the hospital managed the incident by stating that Marawi’s death was not related to the vaccine, he had been poisoned.
Reports also state that the hospital recruited several vulnerable participants who did not t know how to read and write or even phone that could facilitate communication which was the principal investigator and the ethics committee ought to have intensified their efforts to counsel participants and follow them up.
