Phase III trial of Covaxin meets primary endpoint in COVID-19 phase III study.- Ocugen/Bharat Biotech

Covaxin demonstrated overall efficacy of 77.8% (95% CI; 65.2-86.4), achieving its primary endpoint. One hundred and thirty positive COVID-19 cases were observed: 24 in the vaccine group and 106 in the placebo group. Sixteen severe cases were observed: one in the vaccine group and 15 in the placebo group, achieving an efficacy of 93.4% (95% CI; 57.1-99.8) with respect to severe COVID-19 infection.

In the Phase III trial conducted by Bharat Biotech, subjects vaccinated with Covaxin achieved greater protection against emerging B.1.617.2 (delta) and B.1.351 (beta) variants than those who had previous natural infections. Results showed an efficacy rate of 65.2% (95% CI; 33.1-83.0). Adverse events reported were low, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events, side effects that keep many from considering taking current vaccines. Both adverse events and severe adverse events reported in the vaccine group were reported at similar rates to the placebo group.

Ocugen recently announced that it will pursue submission of a Biologics License Application (BLA) for its COVID-19 vaccine candidate, Covaxin in the United States and has initiated discussions with Health Canada for regulatory approval.