Bharat Biotech, manufacturer of Covaxin, has submitted application to the World Health Organisation (WHO) for Emergency Use Listing (EUL).
The company became the second made in India vaccine to apply at WHO for authorisation. Bharat Biotech had submitted its Expression of Interest (EOI) with WHO on April 19.
Now, a pre-submission meeting is slated to be held in May-June 2021.
Bharat Biotech had in April 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% against mild, moderate, and severe COVID-19 disease.
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.
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.