Bharat’s Covaxin Phase 3 trials show 81% efficacy

NEW DELHI: Bharat Biotech on Wednesday said its COVID-19 vaccine Covaxin has demonstrated an interim vaccine efficacy of 81 per cent in Phase 3 clinical trials.

The process involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research, the Hyderabad-based firm said. The Phase 3 study enrolled participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities, it added. 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 Covaxin group, resulting in a point estimate of vaccine efficacy of 80.6 per cent, Bharat Biotech said.

“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,” Bharat Biotech Chairman & Managing Director Krishna Ella said. Covaxin demonstrates a high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants, he added. On Monday, Prime Minister Narendra Modi was administered Covaxin on the very first day of expansion of the inoculation drive to cover people aged 60 and above and those between 45-59 having co-morbidities.

In January India’s drugs regulator had approved Oxford vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin for restricted emergency use in the country, paving the way for a massive inoculation drive. Covishield had shown an efficacy rate of 70 per cent after two full doses.