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v t e

iNCOVACC (codenamed BBV154)^[1] is an intranasal COVID-19 vaccine candidate developed by Bharat Biotech,^[2][3] American company Precision Virologics^[4][5] and the Washington University School of Medicine in St Louis, Missouri, United States.^[6][7]

History

Clinical trials

Phase I trials

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]

Authorizations

India

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]