The much-awaited result from the phase 3 clinical trials of Covaxin, the vaccine that has been granted emergency use authorization under a trial mode, is finally out and the news seems encouraging. What is however awaited now is peer review, more granularity of the data, and the full results of the study that are to follow. “Interim efficacy results are a planned analysis and are showing very good results for Covaxin. This is excellent news,” says Dr Gagandeep Kang, a highly regarded medical scientist and professor at the Christian Medical College, Vellore. “Now, we should wait for full results at 130 cases, a breakdown by severity and their secondary outcomes of asymptomatic infection and viral loads,” says Dr Kang, who is also on the board of CEPI (Coalition for Epidemic Preparedness Innovations), a leading global medical charity.
Dr Kang was responding to a Financial Express Online question on what she thought of the Covaxin results. The vaccine, developed by Bharat Biotech in partnership with the Indian Council of Medical Research, announced an “interim clinical efficacy of 81 percent” on Wednesday, 3 March evening. A note sent out by Bharat Biotech says, “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 BBV152 (COVAXIN) group, resulting in a point estimate of vaccine efficacy of 80.6 percent.”
It also says: “Bharat Biotech expects to share further details of the trial results as additional data become available. 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.”
This apparently is crucial as the company points out that “more than 40 countries globally have expressed their interest in COVAXIN. These countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity.”
The note also quotes its founder and chairman Krishna Ella as saying: “Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today’s results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants.”