Subject Expert Committee (SEC) under India's drug regulator on June 22 approved Bharat Biotech's phase-3 trial efficacy data for its Covid-19 vaccine ‘Covaxin’. As per the data submitted, Covaxin has shown the efficacy of 77.8% from the trial conducted on 25,800 subjects, reported news agency ANI. The meeting took place before Bharat Biotech's 'pre-submission' meeting on June 23 with the World Health Organization (WHO), for the approval for their Covid-19 vaccine. Reportedly, the Hyderabad-based vaccine manufacturing company Bharat Biotech submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI) over the weekend. Bharat Biotech's Covaxin is one of the three vaccines which are currently being used in India. The phase III data of its vaccine have been questioned various times & that is what makes the data crucial which will ascertain the efficacy of the vaccine. The company has developed the vaccine in association with the Indian Council of Medical Research (ICMR). In May, Bharat Biotech had said that an emergency use listing (EUL) application had been submitted to WHO & regulatory approvals were expected between July & September.
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