The efficacy against severe COVID-19 disease was 100%, Bharat Biotech claimed, but that against protecting from asymptomatic COVID-19 infection was 70%
The efficacy of Covaxin has dropped a tad lower – 78% – than the 81% reported in March. On Wednesday, Bharat Biotech, via a press release, announced results from an interim analysis of its phase 3 trial. The efficacy against severe COVID-19 disease was 100%, the company claimed, but that against protecting from asymptomatic COVID-19 infection was 70%.
The analysis was on a data set of 127 Covid positive volunteers.
The safety and efficacy results from the final analysis would 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,” Bharat Biotech said in a statement.
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.”
Prof. Balram Bhargava, Secretary Dept. of Health Research & Director General, Indian Council of Medical Research, said, “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.”
So far around 11 million doses of Covaxin have been administered in India’s vaccination drive, far below the nearly 117 million doses of Covishield. Unlike the latter, Covaxin is a fully indigenous product with the viral strain isolated at the ICMR-National Institute of Virology. Though it was granted emergency use authorisation in January, it was done without providing efficacy data.
“The company’s efforts to further develop COVAXIN continues, with clinical trials planned in India and globally to evaluate its safety and immunogenicity in younger age groups, the impact of booster doses, and protection against SARS-CoV-2 variants,” a press statement from the company underlined.
The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.
The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the Covaxin group, resulting in a point estimate of vaccine efficacy of 80.6%.