Bharat Biotech Wednesday reported that its aboriginal coronavirus vaccine, Covaxin, showed an interim vaccine efficacy of 81% in the Phase 3 clinical trial.
On January 3, the Drug Controller General of India authorised Covaxin for limited use in an urgent situation. The permission was granted without effectiveness evidence since Bharat Biotech had not completed hiring and vaccinating enough patients for Phase 3 trials.
As part of the administration’s vaccination initiative against the coronavirus, the vaccine has been provided to healthcare and frontline staff “in clinical trial form” so far.
The first interim study, according to the Hyderabad-based vaccine manufacturer, is centered on 43 reports, with 36 cases of Covid-19 observed in the placebo group and seven cases in the Covaxin group, yielding an 80.6 % prediction equation of vaccine efficacy.
According to the firm, the interim review revealed that extreme, debilitating, and medically attended adverse effects occurred in low numbers and were evenly distributed between the vaccine and placebo classes.
The findings of the Phase 3 trial are significant since the corporation applied to the Central Drugs Standard Control Organization (CDSCO) for permission to perform late-stage clinical trials of Covaxin in children aged 5 to 18.