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COVID19 vaccine: Bharat Biotech to submit revised Phase 3 clinical trial protocol to DCGI soon

India’s Bharat Biotech will be submitting the Phase 3 clinical trial to the drugs controller general of India (DCGI) for its anti-coronavirus disease (Covid-19) vaccine candidate, Covaxin, early next week.

While they had approval for the Phase 3, the country’s apex drugs regulator has asked the company to revise certain details of the protocol it had submitted on October 2.

“DCGI has asked us to change a few details in the protocol. These are minor procedural changes. We are currently in the process of making the necessary changes, and will hopefully re-submit the proposal to CDSCO [Central Drugs Standard Control Organisation] in the next few days,” Sai Prasad, executive director, Bharat Biotech International Ltd., told HT.

Bharat Biotech has completed the Phase 1 trial, and submitted the results, which showed no major safety concern, to DCGI. For Phase 2, the safety test is complete, and the immunogenicity test (to know body’s immune response to the vaccine) is currently underway.

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