The results of Phase 3 trials of Bharat Biotech’s Covaxin have come and the data shows the vaccine is 77.8 percent effective against Covid19 infection. The phase 3 clinical trials were conducted all across India.
According to sources, trial data and results will now be sent to the Drugs Controller General of India (DCGI) by the Subject Expert Committee (SEC) for review. Bharat Biotech has claimed that the Covaxin vaccine shows 77.8 percent efficacy and SEC is looking at the data.
However, the data is not been published in an internationally recognized peer-reviewed journal yet. According to Bharat Biotech, the publishing would only happen after submission to the regulator.
The Phase 3 trials for Covaxin were conducted on 25,800 subjects. Earlier, in March, the first interim analysis of Phase 3 results indicated that the Bharat Biotech’s vaccine is 81 percent effective against preventing coronavirus in those without prior infection after the second dose.
Also Read: Explained: Why US FDA declined emergency use authorization to Covaxin?
Meanwhile, the World Health Organisation (WHO) has accepted the EoI ie Expression of Interest for Covaxin and has scheduled a pre-submission meeting on June 23. The meeting will not be a detailed review of Covaxin but Bharat Biotech will have the opportunity to submit a summary on the overall quality of the jab which will be a step closer to getting a WHO emergency use listing (EUL).
The emergency use listing (EUL) will help Bharat Biotech to export its vaccine and will enable international travel for Indians who have administered Covaxin, which is not yet recognized by some foreign governments.