Bharat Biotech’s Covaxin is 77.8 per cent effective in preventing COVID-19, according to the results of Phase III trial data approved by the subject expert committee of DCGI – sources said on Tuesday.
Phase III trial data was submitted to the national drug regulator over the weekend and was approved at a meeting of the SEC this afternoon.
The data has not yet been fully published in an internationally recognized, peer-reviewed journal; Manufacturers Bharat Biotech said earlier this month that the drug would be published after submission to the regulator and within a time frame of around three months.
The “first interim analysis” of Phase III results, presented in March, indicated that Covaxin was 81 percent effective in preventing COVID-19 in people with no prior infection after the second dose.
The data also showed a 100 percent reduction in the chances of hospitalization in case of infection.
Covaxin was approved for emergency use last year while still in clinical trials; It was given a “restricted use in emergency in the public interest”, which raised questions and was also seen as contributing to the vaccine hesitation that marked the early stages of India’s vaccination campaign.
The final Phase III trial data will go a long way towards solving doubts and concerns as the government looks to speed up the pace of vaccination across the country.