Bharat Biotech's Covaxin is 77.8 per cent effective in protecting against COVID-19 - according to results of Phase III trial data approved by the DCGI's Subject Expert Committee - sources said on Tuesday.
Phase III trial data had been presented to the national drug regulator over the weekend and was cleared at a meeting of the SEC this afternoon.
The data has not yet been fully published in an internationally recognised, peer-reviewed journal; manufacturers Bharat Biotech earlier this month said publication would take place after submission to the drug regulator and within a timeline of approximately three months.
The "first interim analysis" of Phase III results, presented in March, indicated Covaxin was 81 per cent effective in preventing COVID-19 in those without prior infection after the second dose.
Data also showed a 100 per cent reduction in chances of hospitalisation in case of infection.
Covaxin was cleared for emergency use last year while still in clinical trials; it was given "restricted use in emergency situation in public interest", which raised questions and was also seen as contributing to vaccine hesitancy that marked the early stages of India's vaccination drive.
Final Phase III trial data will go a long way towards resolving doubts and concerns as the government looks to increase the pace of vaccination across the country.