Bharat Biotech, a global leader in vaccine innovation, developing vaccines for infectious diseases, today announced the first interim analysis of its BBV152 (COVAXIN).
It is India’s first COVID-19 Vaccine which demonstrated interim clinical efficacy of 81%. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research.
The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities.
“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%.