Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease. The efficacy against severe COVID-19 disease was 100% (95%CI: 60-100), with an impact on reduction in hospitalisations.
Bharat Biotech announced phase 3 interim analysis results of Covaxin. 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% (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease.
The efficacy against severe COVID-19 disease was 100% (95%CI: 60-100), with an impact on reduction in hospitalisations.
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The efficacy against asymptomatic COVID-19 infection was 70%, 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% over the age of 60, with analysis conducted 14 days post 2nd 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 (ICMR), making it a true public, private partnership towards the public health.
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.
Several million doses of the Indian made vaccine 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.
More than 60 countries globally have expressed their interest in the vaccine and these countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity across the whole SARS-CoV-2 virus.
The capacity expansion has been implemented across multiple facilities in Hyderabad and Bangalore to reach nearly 700 million doses/year, one of the largest production capacities for Inactivated viral vaccines worldwide.
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