Bharat Biotech's COVID-19 vaccine has shown an overall interim clinical efficacy of 78 per cent and 100 per cent efficacy against severe COVID-19 disease.
Announcing the interim results from Phase III trials of its COVID-19 vaccine Covaxin, Bharat Biotech said the second interim analysis is 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 per cent against mild, moderate, and severe COVID-19 disease. The efficacy against severe COVID-19 disease was 100 per cent, with an impact on reduction in hospitalisations. The efficacy against asymptomatic COVID-19 infection was 70 per cent, suggesting decreased transmission in COVAXIN recipients," the company said in a statement.
"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 hospitalisations and disease transmission, respectively," Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech, said.
Covaxin has been developed through collaboration between Bharat Biotech and Indian Council of Medical Research (ICMR). The company stated that the safety and efficacy results from the final analysis of the clinical trials will be available in June, and the final report will be submitted to a peer-reviewed publication. "Based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of COVAXIN," the company said.
The Phase 3 study 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 second dose. COVAXIN was developed with seed strains received from the National Institute of Virology, and the Phase 3 clinical trial was co-funded by the Indian Council of Medical Research. The protocols for manufacturing, testing and release of inactivated vaccines have been tried, tested and validated across several of our vaccines; these also meet the requirements of WHO, Indian and other regulatory authorities. 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, the company said.
"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," Prof. Balram Bhargava, Secretary Dept. of Health Research & Director General, Indian Council of Medical Research, said.
More than 60 countries globally have expressed their interest in COVAXIN.
The company is ramping up its production capacity across multiple facilities in Hyderabad and Bangalore to reach 700 million doses/year, one of the largest production capacities for Inactivated viral vaccines worldwide.