Covaxin demonstrates 78% efficacy in Phase-3 interim analysis
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-second dose
Hyderabad: Covaxin, a vaccine developed by Bharat Biotech, has demonstrated overall interim clinical efficacy of 78% and 100% efficacy against severe COVID-19, the city-based company said on Wednesday announcing phase 3 interim analysis results ofthe vaccine.
“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 vaccine maker said in a press release.
The efficacy against severe COVID-19 disease was 100% with an impact on reduction in hospitalizations. The efficacy against asymptomatic COVID-19 infection was 70%, suggesting decreased transmission in Covaxin recipients, it said.
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 release said.
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-second dose.
Krishna Ella,Chairman and Managing Director of Bharat Biotech, saidefficacy 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, Ella said.
Director General of Indian Council of Medical Research, Balram Bhargava 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% in the second interim analysis. 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.”
Covaxin was approved and introduced initially through Emergency Use Authorization under the clinical trial mode, resulting in robust safety data in real-life conditions.