Covaxin phase 3 analysis results: The final phase 3 analysis of Covaxin, a coronavirus vaccine developed by Bharat Biotech, has shown an overall efficacy of 78 percent in fighting symptomatic novel coronavirus infections. Officials familiar with the development said that the vaccine maker is likely to announce the results in June.
The first interim efficacy analysis had showed vaccine efficacy of nearly 81 percent and the second interim analysis results showed it to be about 78 percent. The final analysis was found to be 78 percent effective, said Dr Sanjay Rai, professor, community medicine department, All India Institute of Medical Sciences (AIIMS), Delhi. The findings are based on analysis of 130 confirmed cases, Hindustan Times reported.
This analysis comes at a time when the makers of the vaccine have applied for approval from the World Health Organization. While the interim analysis may be over, Rai added that the analysed data needs to be reviewed by peer groups and published in a medical journal now. Rai is also the principal investigator of the study site at AIIMS.
Bharat Biotech has co-developed Covaxin with Indian Council of Medical Research (ICMR). A higher number of cases was recorded among the Covaxin trial participants due to the surge in cases because of the second wave and the efficacy data was calculated on this basis. The final analysis results, prioritising the safety and efficacy, will be available in June after which the final report will be submitted to a peer-reviewed publication, AIIMS officials added. The interim analysis results for Covaxin phase 3 trials are almost done and they are in the process of publishing the data, a central government official said on condition of anonymity. Read how to on-site/walk-in register for vaccine here.
While Bharat Biotech did not comment on the final analysis results, the Hyderabad-based vaccine major has on Friday said production and supply of Covaxin is a time-consuming process amidst the shortage of jabs in the country and demand from various states to enhance the production of vaccines. They noted the timeline for manufacturing, testing and release for a batch of Covaxin is around 120 days, "Thus, production batches of Covaxin that were initiated during March this year will be ready for supply only during the month of June," it said in a statement, NDTV reported.