Moderna requests emergency FDA authorization for COVID-19 vaccine
December 1, 2020
Moderna announced yesterday its plan to apply for emergency FDA authorization for its COVID-19 vaccine candidate.
Moderna also reported that the primary efficacy analysis of its phase 3 COVE study of mRNA-1273 demonstrated a high efficacy rate of 94.1%, with a 100% efficacy rate against severe COVID-19. A total of 196 cases of COVID-19, including 30 severe cases, among 30,000 participants were included in the analysis.
Vaccine efficacy was initially reported at the first interim analysis with a total of 95 cases based on pre-specified success criteria on efficacy. Today’s primary analysis was based on the 195 cases, of which 185 cases were observed in the placebo group versus 11 cases in the mRNA-1273 group. The primary end point is based on the analysis of COVID-19 cases confirmed and adjudicated starting 2 weeks following the second dose of the vaccine.
