India’s first coronavirus vaccine COVAXIN, by Hyderabad-based Bharat Biotech, is expected to begin human trials and more than 1,100 people are expected to be enrolled for the same. COVAXIN will be tested on more than 1,100 people in phase 1 and 2 clinical trials. The inactivated coronavirus vaccine received DCGI approval for phase 1 and 2 clinical trials. COVAXIN is derived from a strain of the SARS-CoV-2 virus isolated in NIV, Pune, and transferred to Bharat Biotech to develop into a vaccine candidate.
According to an NDTV report, 375 participants will take part in Phase I. They will be split into three groups of 125 and be administered two doses – one each of the candidate and control vaccine – 14 days apart. Pending satisfactory completion of Phase I, a further 750 participants will be registered for Phase II of the clinical trials. The company has set July 13 as the final date of enrollment for the trials. The company said COVAXIN has demonstrated safety and immune response in preclinical studies. As per reports, the human trial will take at least six to eight months to complete after which the final report will be submitted to the ICMR.
