Covaxin shows 78% efficacy in Ph 3 trials
NEW DELHI: The second interim phase 3 analysis of the first make-in-India coronavirus disease (Covid-19) vaccine, Covaxin, has shown 78% efficacy, its maker Bharat Biotech said on Wednesday.
“[ The vaccine’s] efficacy against Sars-CoV-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and in emergency-use... The efficacy data against severe Covid-19 and asymptomatic infections is highly significant, as this helps reduce hospitalisations and disease transmission, respectively,” said Krishna Ella, chairman and managing editor, Bharat Biotech.
The company first released its preliminary phase 3 analysis results in March, which showed 81% efficacy based on 43 cases.
In this round, vaccine efficacy of 78% was recorded against mild, moderate, and severe symptoms of Covid-19 based on 127 cases.
The efficacy against severe Covid-19 disease was 100%, with a reduction in the number of hospitalisations. The efficacy against asymptomatic Covid-19 infections was 70%, suggesting decreased transmission in Covaxin recipients.
Bharat Biotech has co-developed Covaxin with Indian Council of Medical Research (ICMR).
Safety and efficacy results from the final analysis will be available in June
. Based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of the vaccine.
HYDERABAD: Covaxin, a vaccine developed by Bharat Biotech, has demonstrated overall interim clinical efficacy of 78 per cent and 100 per cent efficacy against severe COVID-19, the city-based company said on Wednesday announcing phase 3 interim analysis results of the vaccine.
“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 per cent (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease,” the vaccine maker said in a press release.
The efficacy against severe COVID-19 disease was 100 per cent with an impact on reduction in hospitalizations.
The efficacy against asymptomatic COVID-19 infection was 70 per cent, suggesting decreased transmission in Covaxin recipients, it said.
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 release said.
The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10 per cent over the age of 60, with analysis conducted 14 days post seconddose.
Krishna Ella,Chairman and Managing Director of Bharat Biotech, saidefficacy against SARS-Cov-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use.