A total of 25,800 subjects will be enrolled and randomized in a 1:1 ratio to receive the BBV152 vaccine and control.
All participants will be assessed for efficacy and safety endpoints and provide a Nasopharyngeal(NP) swab and blood sample before the first dose of IP. The NP swab and blood collected will be subject to RT-PCR and Anti-SARS-CoV-2 IgG antibodies.
The results of this will not affect the enrollment of the participant. Participants who are found to be positive for either RT-PCR Or Anti-SARS-CoV-2 IgG antibodies will be excluded from the primary efficacy analysis. A safety follow-up will be done for all.
On July 2, 2021, Bharat Biotech and Ocugen (NASDAQ: OCGN) announced the results of this Phase 3 trial.
Due to the recent surge in cases, 130 positive COVID cases were recorded, resulting in an overall vaccine efficacy of 77.8% (95%CI: 65.2-86.4) achieving its primary endpoint.
One hundred and thirty positive COVID-19 cases were recorded: 24 in the vaccine group and 106 in the placebo group. Sixteen severe cases were observed: one in the vaccine group and 15 in the placebo group, achieving an efficacy of 93.4% (95% CI; 57.1-99.8) with respect to severe COVID-19 infection.
“The safety and efficacy readouts from Phase III clinical trials present a comprehensive data package for COVAXIN™. This has been a great journey of science leading to translational product development to combat this deadly pandemic,” added Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech.
Based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of COVAXIN.