A low level of severe, serious, and medically attended adverse events was recorded, and it was able to be managed between vaccine and placebo group, the company claimed.
“… Covaxin demonstrated 81 per cent interim efficacy in preventing COVID-19 in those without prior infection after the second dose,” the company said in a statement.
As many as 25, 800 participants aged between 18 and 98 from 25 locations had participated in the phase III Bharat Biotech vaccine trial, which started in the second half of November last year.
“To see efficacy, you need to have a sufficient number who get infected… and you don’t know which group got the vaccine and which the placebo. When you have a sufficient number of positive cases, you can say efficacy is based on good data,” Dr. Randeep Guleira, the chief of Delhi’s AIIMS, was reported as saying in a media report.
“After 43 events they broke the code (checked to see who got the vaccine and who the placebo) and, based on that, vaccine shows the efficacy of around 81 per cent. But we need around 130-140 cases and then break the code to get real efficacy,” he explained.
“An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication,” the company said.