2 years, 11 months ago
SEC Recommends Bharat Biotech to Conduct Late-stage Trials, Submit Booster Protocol
News 18The Subject Expert Committee of India’s drug authority has recommended Bharat Biotech to conduct late-stage trials for its intranasal vaccine BBV154. After discussions and deliberations for almost five hours on Tuesday, the expert panel has asked Bharat Biotech to add a Covishield arm in the booster trails and submit a protocol for the same. Bharat Biotech will submit a revised application tomorrow as per government sources. Bharat Biotech aims to conduct clinical trials on 5,000 healthy subjects: half or 2,500 individuals who have received Covishield and another 2,500 who have been administered Covaxin.
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