The interim analysis was based on accruing more than 87 symptomatic cases of Covid-19. Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% against mild, moderate, and severe Covid-19 disease, the company said.
The efficacy against severe Covid-19 disease was 100%, with an impact on reduction in hospitalizations. The efficacy against asymptomatic Covid-19 infection was 70%, suggesting decreased transmission in Covaxin recipients, the company said in a release.
The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10% over the age of 60, with analysis conducted 14 days post-second dose.
“Efficacy against SARS-Cov-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use. Covaxin is now a global innovator vaccine derived from Research & Development from India. The efficacy data against severe Covid-19 and asymptomatic infections is highly significant, as this helps reduce hospitalizations and disease transmission, respectively,” said Dr Krishna Ella, Chairman and Managing Director at Bharat Biotech.
Safety and efficacy results from the final analysis will be available in June, and the final report will be submitted to a peer-reviewed publication, stated the company.
“I am very pleased to state that Covaxin, the first indigenous Covid-19 vaccine developed by ICMR and BBIL, has shown efficacy of 78% in the second interim analysis. The tireless efforts of our scientists at ICMR and BBIL have resulted in a truly effective international vaccine of the highest standards and efficacy. I am also happy to note that Covaxin works well against most variants of SARS-CoV-2. These findings together consolidate the position of our indigenous vaccine in the global vaccine landscape,” said Prof Balram Bhargava, Secretary Department of Health Research & Director General at Indian Council of Medical Research.
According to the company, more than 60 countries globally have expressed their interest in the indigenously developed vaccine.
To meet the demand, Bharat Biotech on Tuesday also announced their capacity expansion plans that have been implemented across multiple facilities in Hyderabad and Bangalore to reach 700 million doses a year.