The expert panel at Central Drugs Standard Control Organisation (CDSCO) has recommended the top drugs regulator to grant permission to Bharat Biotech to conduct phase III clinical trial using indigenous covid19 vaccine--Covaxin, with subject to the condition. "In continuation of the Subject Expert Committee (SEC) meeting dated 5 Oct, firm presented their data from phase I and II along with animal challenge data in two species including NHP on the Inactivated Corona Virus Vaccine (BBV152) along with the proposal to conduct event-driven phase III clinical trial to assess the efficacy of the vaccine," according to a government official.

"After detailed deliberation and based on the available evidences, the committee recommended for grant of permission to conduct phase III clinical trial subject to the condition that the primary efficacy endpoint for symptomatic cases should be amended as--(i) once a suspect case is confirmed the principal investigator (PI) will evaluate the clinical information to classify it as a symptomatic case," the SEC noted on 118h meeting held on Tuesday.