Hyderabad: Hyderabad-based Bharat Biotech announced the phase 3 interim analysis results of Covaxin, with 78 percent efficacy against mild, moderate, and severe Covid-19 disease. The second interim analysis is based on accruing more than 87 symptomatic cases of Covid-19. The vaccine demonstrated 81 per cent efficacy in the first interim analysis.
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.
The phase 3 study enrolled 25,800 participants between 18 and 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.
Dr Krishna Ella, CMD, Bharat Biotech, said, “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. The efficacy data against severe Covid-19 and asymptomatic infections is highly significant, as this helps reduce hospitalisations and disease transmission, respectively.”
Prof Balram Bhargava, secretary, Department of Health Research and director general, Indian Council of Medical Research, said the Covid-19 vaccine developed by ICMR and Bharat Biotech has shown the efficacy of 78 per cent in the second interim analysis. These findings consolidate the position of the indigenous vaccine in the global vaccine landscape.
Covaxin has been approved and introduced initially through Emergency Use Authorization (EUA) under the clinical trial mode, resulting in robust safety data in real-life conditions.
More than 60 countries globally have expressed their interest in Covaxin. These countries are highly satisfied with the safe, inactivated vaccine technology and data package for safety and immunogenicity across the whole SARS-CoV-2 virus. EUAs have been received from several countries, the company said.
The capacity expansion has been implemented across multiple facilities in Hyderabad and Bengaluru to reach about 700 million doses/year, one of the largest production capacities for inactivated viral vaccines worldwide.
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