Cadila gets nod for Phase III trials of vaccine

Our Correspondent

The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) that met on January 1 and 2, 2021 has granted the permission to Cadila Healthcare Ltd for conduct of the Phase III clinical trial of the Novel Corona Virus-2019-nCov-Vaccine it has developed.

The firm initiated Phase-I/II clinical trial in India in more than 1,000 participants which is ongoing. The interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, firm has sought permission to conduct Phase-III clinical trial in 26,000 Indian participants, which has been recommended by the Subject Expert Committee.

The approval for the third phase of trials for Cadila Healthcare Ltd came even as the CDSCO approved vaccines of M/s Serum and M/s Bharat Biotech for restricted use in emergency situation.