Hyderabad: The city-based Bharat Biotech on 21 April announced the phase 3 interim analysis results of Covaxin and said it had an efficacy of 78 per cent against mild, moderate, and severe COVID-19 cases.
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.
Bharat Biotech said that the efficacy against severe COVID-19 disease was 100 per cent, with an impact on reduction in hospitalizations. The efficacy against asymptomatic COVID-19 infection was 70 per cent, suggesting decreased transmission in Covaxin recipients.
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. Based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of Covaxin.
The phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10 per cent over the age of 60. The analysis was conducted 14 days after the second dose was administered.
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, making it a true public-private partnership towards public health.
"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 and 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, the chairman and managing director of Bharat Biotech.
He added that the protocols for manufacturing, testing, and release of inactivated vaccines have been tried, tested, and validated across several of their vaccines and these also meet the requirements of WHO and 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, Dr. Krishna said.
Several million doses of Covaxin have been supplied and administered in India and several other countries with an excellent safety record, evident by the minimal or lack of adverse events post-immunization. Covaxin was approved and introduced initially through Emergency Use Authorization under the clinical trial mode, resulting in robust safety data in real-life conditions.
Suchitra Ella, the joint managing director of Bharat Biotech said Covaxin's evidence-based development has proved its suitability for global access, with excellent efficacy results against symptomatic, asymptomatic, and severe disease.
Bharat Biotech has announced that it has expanded its manufacturing capacities across multiple facilities in Hyderabad and Bangalore to produce around 700 million doses per year.