India-based Bharat Biotech announced on March 3, 2021, the first interim analysis of its BBV152 (COVAXIN®), the whole virion inactivated COVID-19 vaccine candidate. The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the BBV152 (COVAXIN) group, resulting in a point estimate of vaccine efficacy of 80.6%.
The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. The trial's conduct and monitoring are as per Good Clinical Practice guidelines and have been outsourced to IQVIA.
Another analysis is planned for 87 cases, and the final analysis is planned for 130 cases.
“With today’s results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants. COVAXIN demonstrates a high clinical efficacy trend against COVID-19, but also significant immunogenicity against the rapidly emerging variants,” commented Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech, in a related press statement.
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization Prequalifications.