Covaxin, a vaccine developed by Bharat Biotech, has demonstrated overall interim clinical efficacy of 78 per cent and 100 per cent efficacy against severe COVID-19, the Hyderabad-based company said on Wednesday announcing phase 3 interim analysis results of the vaccine.
The vaccine maker noted that the second interim data of the Phase III study also showed that chances of hospitalisation due to the infectious disease were reduced by 10 per cent after taking the Covaxin jab. Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78 per cent against mild, moderate, and severe COVID-19 disease, Bharat Biotech said in a statement. The efficacy against asymptomatic COVID-19 infection was 70 per cent, suggesting decreased transmission in Covaxin recipients, it added. “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 R&D in India,” Bharat Biotech Chairman and Managing Director Krishna Ella said.
The efficacy data against severe COVID-19 and asymptomatic infections is highly significant, as this helps reduce hospitalisations and disease transmission, respectively, he added. The protocols for manufacturing, testing and release of inactivated vaccines have been tried, tested and validated across several of company’s vaccines. These also meet the requirements of WHO as well as Indian and other regulatory authorities, Ella said.
“These protocols have delivered consistent results over a 15-year period with more than 300 million doses supplied globally, with excellent safety and performance record,” he added. Bharat Biotech said safety and efficacy results from the final analysis will be available in June.
The final report will be submitted to a peer-reviewed publication. The Phase III study for Covaxin enrolled 25,800 participants between 18-98 years of age, including 10 per cent over the age of 60, with analysis conducted 14 days post the second dose. Covaxin has been developed with seed strains received from the National Institute of Virology. The Phase III clinical trial was co-funded by the Indian Council of Medical Research (ICMR), making it a public private partnership towards public health. “The tireless efforts of our scientists at ICMR and Bharat Biotech 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,” Secretary, Department of Health Research and ICMR Director General Balram Bhargava said.
Balram added that the firm’s efforts to further develop COVAXIN would continue, with clinical trials planned in India and globally to evaluate its safety and immunogenicity in younger age groups, the impact of booster doses, and protection against SARS-CoV-2 variants.
Suchitra Ella, Joint Managing Director said capacity expansion has been implemented across multiple facilities in Hyderabad and Bangalore to approximately 700 million doses/year.
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