The a great deal-awaited outcome from the phase 3 clinical trials of Covaxin, the vaccine that has been granted emergency use authorization beneath a trial mode, is lastly out and the news appears encouraging. What is nevertheless awaited now is peer overview, more granularity of the information, and the complete benefits of the study that are to stick to. “Interim efficacy results are a planned analysis and are showing very good results for Covaxin. This is excellent news,” says Dr Gagandeep Kang, a very regarded health-related 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 major worldwide health-related charity.
: Covaxin phase 3 trial benefits out, Bharat Biotech says its Covid vaccine has 81% efficacy rate
Dr Kang was responding to a TheSpuzz Online query on what she believed of the Covaxin benefits. The vaccine, created 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 essential as the firm 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.”