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The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended green signal for phase III clinical trials of Covaxin, the inactivated Covid-19 vaccine developed by Bharat Biotech India Limited, together with scientists from the Indian Council of Medical Research.
SEC, which met on Tuesday evening, analysed phase I and phase II trials data, as well as animal challenge data from studies in two species, including a non-human primate, and recommended the grant of permission to conduct phase III trials with some minor changes, said an official statement on Thursday.
Recently, the drug regulator allowed Bharat Biotech to cut down on the number volunteers to be used for the vaccine’s phase II clinical trials to 380 as its immunogenicity results in the phase I trials were found to be very good, according to the sources.
For the Phase III trials, the firm plans to enlist around 22,500 healthy volunteers, it is learnt.
Bharat Biotech, along with Zydus Cadila and Serum Institute of India, which is conducting clinical trials on Oxford University-AstraZeneca vaccine, are some of the frontrunners in Covid-19 vaccine development in India.
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