Bharat Biotech on April 21 announced phase 3 interim analysis results of Covaxin demonstrated that COVID-19 vaccine has 78 percent efficacy.
Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78 percent against mild, moderate, and severe COVID-19 disease, the company said.
The second interim analysis is based on accruing more than 87 symptomatic cases of COVID-19.
The efficacy was slightly lower than the first interim data that indicated efficacy of 81 percent at a four-week interval between two doses.
The efficacy against severe COVID-19 disease was 100 percent, the company said.
The efficacy against asymptomatic COVID-19 infection was 70 percent 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, making it a true public, private partnership towards public health.
Dr. Krishna Ella, Chairman & Managing Director, 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 hospitalizations and disease transmission, respectively.``
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.
Prof. Balram Bhargava, Secretary Dept. of Health Research & Director General, Indian Council of Medical Research, said, “I am very pleased to state that Covaxin, the first indigenous COVID-19 vaccine developed by ICMR and BBIL, has shown the efficacy of 78 percent in the second interim analysis.”
Several million doses of Covaxin have been supplied and administered in India and several other countries.
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