Bharat Biotech’s Covaxin Found 100% Effective Against ‘Severe Covid Disease’ In Phase-3 Interim Analysis
Mumbai: Bharat Biotech and ICMR have announced interim results from phase 3 trials of Covaxin that demonstrate overall interim clinical efficacy of 78% and 100% efficacy against severe COVID-19 disease.
The second interim results showed that India’s first COVID-19 vaccine demonstrated strong primary efficacy against severe COVID-19 disease.
The second interim analysis is based on more than 87 symptomatic cases of COVID-19. Due to the recent surge in cases, 127 symptomatic cases were reported, resulting in a point estimate of 78% (95% CI: 61–88) vaccine efficacy against mild, moderate and severe COVID-19 disease.
The efficacy against severe COVID-19 disease was 100% (95% CI: 60–100), which reduced the effect of hospitalization. The efficacy against asymptomatic COVID-19 infection was 70%, suggesting a reduction in transmission in the Covaxin recipient.
Safety and efficacy results from the final analysis will be available in June, and the final report will be presented to a peer-reviewed publication. Based on the achievement of the success criteria, placebo recipients are now eligible to receive two doses of COVAXIN.
The efficacy was slightly lower than earlier interim data that indicated the effectiveness of 81% at four-week intervals between the two doses.
The Phase 3 study included 25,800 participants between the ages of 18 and 98, including 10% over the age of 60, with the analysis, conducted a second dose after 14 days.
“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 and 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,” Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech, said.
Protocols for the manufacture, testing, and release of inactivated vaccines have been tested, tested, and validated in many of our vaccines; They also meet the requirements of WHO, Indian and other regulatory authorities. These protocols have resulted in excellent safety and performance records with over 300 million doses over a period of 15 consecutive years, the company statement read.
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