Bharat Biotech’s Covaxin showed an interim clinical efficacy of 78% against mild, moderate, and severe Covid-19 disease during Phase 3 trials.
The efficacy against severe Covid-19 disease was 100%, with an impact on reduction in hospitalizations, the company said in a statement. The efficacy against asymptomatic Covid-19 infection was 70%, suggesting decreased transmission in Covaxin recipients.
“The efficacy data against severe COVID-19 and asymptomatic infections is highly significant, as this helps reduce hospitalizations and disease transmission, respectively,” said Krishna Ella, Chairman & Managing Director, Bharat Biotech.
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).
ICMR also said Covaxin works against multiple variants of Covid-19 and effectively neutralises the double mutant strain as well.
