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Bhopal Hospital's Serious Breach of Covaxin Trial Protocols Could Prove Costly


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. ....

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