Biznextindia: Indian biotechnology firm Bharat Biotech on Wednesday said that its indigenously developed COVID-19 vaccine COVAXIN (BBV152) has demonstrated an interim vaccine efficacy of 81% in its Phase 3 clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research.
India’s drug regulator- Drug Control General of India (DCGI) on January 3 had approved COVAXIN for restricted use in an emergency situation. However, several political parties had raised questions over approval before the phase-3 clinical trials.
The vaccine has been jointly developed by Bharat Biotech and Indian Council for Medical Research (ICMR), the apex body for bio-medical research in India.
“Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. 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 high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants,” said Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech.
BBV152 contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells. It is stable at 2 to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels. BBV152 has a 28-day open vial policy as a unique product characteristic, thus reducing vaccine wastage by approximately 10-30%.
BBV152 is based on an established manufacturing platform with a better safety profile when compared to other vaccine platforms. The inclusion of the Algel-IMDG adjuvant enhances T-cell immune responses to COVID-19, leading to long-term protection.