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Bharat Biotech and ICMR Announce Interim Results from Phase 3 trials of COVAXIN

Bharat Biotech and ICMR Announce Interim Results from Phase 3 trials of COVAXIN

The second interim results showed India’s First COVID-19 Vaccine had demonstrated strong primary efficacy against severe COVID-19 disease

Hyderabad

Bharat Biotech, a global leader in vaccine innovation, developing vaccines for infectious diseases, 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 hospitalizations. 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, making it a true public, private partnership towards public health.

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