Covaxin shows 78% efficacy in Phase 3 interim analysis, says Bharat Biotech

The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10% over the age of 60, says the Hyderabad-based firm

Indigenously developed Covid-19 vaccine, Covaxin, demonstrated overall interim clinical efficacy of 78% in Phase 3 trials, said Bharat Biotech and ICMR on Wednesday. 

Bharat Biotech's Covaxin has received Emergency Use Authorizations (EUAs) for COVID-19 treatment in India and in several countries across the globe with another 60 in the process.

"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," said Hyderabad-based Bharat Biotech in a statement. 

The efficacy against severe Covid-19 disease was 100%, with an impact on reduction in hospitalisations. 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 company further said. 

The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10% over the age of 60, with analysis conducted for 14 days post second 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. 

Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech, said, “Efficacy against SARS-Cov-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use. Covaxin is now a global innovator vaccine derived from Research & Development from India. The efficacy data against severe COVID-19 and asymptomatic infections is highly significant, as this helps reduce hospitalizations and disease transmission, respectively.” 

Covaxin neutralises multiple variants of SARS-CoV-2 and effectively works against the double mutant strain as well, the Indian Council of Medical Research (ICMR) said earlier on Wednesday.

Balram Bhargava, Director General, Indian Council of Medical Research, said, “I am very pleased to state that Covaxin, the first indigenous Covid-19 vaccine developed by ICMR and BBIL, has shown the efficacy of 78% in the second interim analysis. The tireless efforts of our scientists at ICMR and BBIL have resulted in a truly effective international vaccine of the highest standards and efficacy. I am also happy to note that Covaxin works well against most variants of SARS-CoV-2. These findings together consolidate the position of our indigenous vaccine in the global vaccine landscape.”