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Bharat Biotech gets go-ahead to conduct Phase-III trials of Covaxin

The around 28,500 people expected to enrol for the Phase-III trials would be given two doses of the investigational vaccine

Covaxin, bharat biotech, covid, coronavirus, vaccine, drugs, medicine, pharma
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The SEC had asked for the safety and immunogenicity data from the ongoing Phase-II trials.

Sohini Das Mumbai
With Hyderabad-based Bharat Biotech receiving an approval to conduct Phase-III trials for Covaxin, India inches closer to having its own vaccine to fight the coronavirus pandemic. This is crucial as the government plans to start vaccinating the healthcare and essential workers starting January.

The Subject Expert Committee (SEC) at Central Drugs Standard Control Organisation (CDSCO) which is reviewing proposals related to Covid-19 drugs and vaccines has granted permission to the vaccine maker to start Phase-III trials after it assessed data from the Phase-I and II trials along with the animal challenge study.

"In continuation of the SEC meeting dated 05.10.2020,

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