Bharat Biotech has admitted that in August, there was an adverse event during the Phase-1 clinical trials of its Covid-19 vaccine.
The firm said subject was now safe. Though it was reported to the drug regulator within 24 hours, the event turned out to be unrelated to the vaccine.
“The adverse event was investigated, and presented to the CDSCO-DCGI, prior to obtaining permission for Phase-2 and Phase-3 trials," it said.
The firm is now conducting Phase-3 trials and the event will have no impact on timelines.
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