Hyderabad: Bharat Biotech, a global leader in vaccine innovation,developing vaccines for infectious diseases, today announced the first interim analysis of itsBBV152 (COVAXIN) where it showed it was 81 percent effective.
The whole virion inactivated COVID-19 vaccine candidate demonstratedan interim vaccine efficacy of 81% in its Phase 3 clinical trial," the company said in a statement.
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 againstcoronavirus. With today’s results from our Phase 3 clinical trials, we have now reported data onour 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 significantimmunogenicity 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 Verocells.
It is stable at 2 to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulationthat permits distribution using existing vaccine supply chain channels.
BBV152 has a 28-dayopen vial policy as a unique product characteristic, thus reducing vaccine wastage byapproximately 10-30%.BBV152 is based on an established manufacturing platform with a better safety profile whencompared to other vaccine platforms.
The inclusion of the Algel-IMDG adjuvant enhances T-cellimmune responses to COVID-19, leading to long-term protection.
“I want to thank every one of the participants, who volunteered to participate in this vitalclinical trial, our partners, principal investigators across 25 study sites, and our team at BharatBiotech who dedicated their time to this vaccine discovery,” said Suchitra Ella, JointManaging Director, Bharat Biotech.
“We could not have achieved this public-privatepartnership milestone without the relentless commitment of those involved.”