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Covaxin: Bharat Biotech's Covid vaccine candidate gets Phase 3 trials nod

In a statement published on its website, the panel said it recommended granting the approval after studying the firm's Phase I and II data along with 'animal challenge data in two species'

Covaxin, bharat biotech, covid, coronavirus, vaccine, drugs, medicine, pharma
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The Hyderabad-based vaccine maker had applied to the DCGI on October 2

BS Web Team New Delhi
Drugs Controller General of India (DCGI's) Expert Committee has given its nod to Phase III clinical trials of Bharat Biotech's Covid-19 vaccine Covaxin.

In a statement published on its website, the panel said it recommended granting the approval after studying the firm's Phase I and II data along with 'animal challenge data in two species'.

"After detailed deliberation and based on the available evidences, the committee recommended for grant of permission to conduct Phase III clinical trial," the statement reads. 

It, however, notes that the approval is subject to the condition that the primary efficacy endpoint for symptomatic cases should

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First Published: Oct 22 2020 | 10:44 PM IST

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