Bharat Biotech, ICMR announce interim results from phase 3 trials of Covaxin

Bharat Biotech and Indian Council of Medical Research (ICMR) announced phase 3 interim analysis results of Covaxin vaccine which is being given in India. 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 company said on April 21.

The efficacy against severe COVID-19 disease was 100% (95%CI: 60-100), with an impact on reduction in hospitalizations. The efficacy against asymptomatic COVID-19 infection was 70%, suggesting decreased transmission in Covaxin recipients, the company further added.

A press release stated that 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 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 (ICMR), making it a public-private partnership towards public health.

Krishna Ella, chairman & managing director at 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. Covaxin is now a global innovator vaccine derived from research & 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.”

Balram Bhargava, secretary department 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% in the second interim analysis. The tireless efforts of our scientists at ICMR and BBIL have resulted in a truly effective international vaccine of the highest standards and efficacy. 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.”

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