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On recommendation by the Subject Expert Committee (SEC) under the Indian drug regulator, the company conducted phase 1 clinical trials using 75 volunteers and submit safety and immunogenicity data for the committee's consideration before it proceeds to the second phase of the trial.[8]
Phase II and III trials
On 12 August 2021, after evaluating the results of phase I trial data, the drug regulator approved for phase II/III randomized trials that involves evaluation of the immunogenicity and safety of Covaxin with BBV154 in healthy volunteers.[9]
On 24 December 2022, the Government of India approved the intranasal vaccine for inclusion in the vaccination programme as a booster dose for those above 18 years of age.[10][11]
COVID-19 portal
This page was last edited on 24 August 2023, at 14:37