Bharat Biotech has announced the Phase 3 clinical trial results for its coronavirus vaccine candidate Covaxin. The company said that Covaxin demonstrated efficacy of 81 per cent in the trials. "Covaxin demonstrated 81 per cent interim efficacy in preventing COVID-19 in those without prior infection after the second dose," said the company. The vaccine candidate is also effective against the UK variant, stated Bharat Biotech. Covaxin is currently being administered, along with Serum Institute's Covishield in the COVID-19 vaccination drive.
Data from 25,800 participants who received a vaccine or placebo in 1:1 ratio showed that the vaccine was well-tolerated, the firm said. It said that the trial, conducted with the Indian Council of Medical Research, was the largest in India.
Dr. Krishna Ella, Bharat Biotech Chairman and Managing Director said, "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."
The vaccine is stable at 2-8 degree Celsius and is shipped in a ready-to-use formulation, it said. "BBV152 has a 28-day open vial policy as a unique product characteristic, thus reducing vaccine wastage by approximately 10-30 per cent," stated the company.
Joint Managing Director Suchitra Ella said, "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."
The Phase 3 study enrolled 25,800 participants from 18 to 98 years of age. As many as 2,433 were over 60 years and 4,500 were with comorbidities. "Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralise the UK variant strains and other heterologous strains, which has been published in bioRxiv," stated the company.
"Bharat Biotech expects to share further details of the trial results as additional data become available. An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication," said the company.
It added that more than 40 countries have expressed their interest in Covaxin.