Hyderabad: Covaxin of the city-based Bharat Biotech was on Saturday recommended for approval for restricted use’ in ‘emergency situations’ in public interest with different mutant strains are emerging in SARS-CoV-2, the virus that causes Covid-19.
On Friday, Covishield, the Oxford-AstraZeneca vaccine manufactured by the Serum Institute of India was recommended for emergency use authorisation (EUA).
On Saturday, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) granted permission to Bharat Biotech in the ‘clinical trial’ mode and with ‘abundant precaution’. According to pharmacologists, the permission in ‘clinical trial’ mode is being given due to limited data available from the trials.
Bharat Biotech has submitted data from Phase 1 and 2 trials to the CDSCO and the Drugs Controller General of India. But only 23,000 volunteers were enrolled in the Phase 3 human trials against the requirement of 26,000…