Mumbai: Bharat Biotech has said its COVID-19 vaccine COVAXIN demonstrated 81% interim efficacy in preventing COVID-19 in those without prior infection after the second dose in the 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 our fight against science and coronavirus. With predictable results from our Phase 3 clinical trials, we have now expanded our COVID-19 vaccine from Phase 1, 2, and approximately Reported 3 trials consisting of 27,000 participants.
Covaxin exhibits a high clinical efficacy trend against COVID-19, but significant immunogenicity against rapidly emerging variants, said Bharata Biotech, said Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech.
“I want to thank every one of the participants, who volunteered to participate in this vital clinical trial, our partners, principal investigators across 25 study sites, and our team at Bharat Biotech who dedicated their time to this vaccine discovery,” said Mrs Suchitra Ella, Joint Managing Director, Bharat Biotech.
“We could not have achieved this public-private partnership milestone without the relentless commitment of those involved.”
BBV152 contains a completely inactive SARS-CoV-2 vaccine, which is produced in Vero cells. It is stable at 2 to 8 ° C (refrigerated) and is sent in ready-to-use liquid formulations that allow delivery using existing vaccine supply chain channels. BBV152 has a 28-day open vial policy that is a unique product feature, thus reducing vaccine wastage by approximately 10–30%.
The BBV152 is based on an established manufacturing platform with a better safety profile than other vaccine platforms. Inclusion of the algel-IMDG adjuvant enhances the T-cell immune response to COVID-19, leading to long-term protection.