Hyderabad: Bharat Biotech today announced the first interim analysis of COVAXIN, which has been developed by the company, shows the Covid-19 vaccine candidate 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.
“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 Krishna Ella, Chairman and Managing Director, Bharat Biotech.
The company stated the Covid vaccine candidate 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.
The COVAXIN has a 28-day open vial policy as a unique product characteristic, thus reducing vaccine wastage by approximately 10-30%.
Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains, which has been published in bioRxiv.