Nasal vaccine: Bharat Bio told to submit efficacy data from Phase-3 trials

India may start vaccine exports as soon as today

The expert panel of the Central Drugs Standard Control Organisation (CDSCO) has asked Bharat Biotech to submit the efficacy data from Phase-3 trials, before it approves the application to conduct Phase-1 trial for its nasal vaccine, said sources. 

Bharat Biotech had recently sought the Drugs Controller General of India’s approval to conduct Phase 1 clinical trials of its nasal vaccine. For any clinical trial and vaccine approval, the CDSCO refers to the subject expert committee (SEC) for recommendations.

The SEC met on Tuesday to discuss the proposal from the vaccine maker. A source added that the panel has sought more data from