Moderna to Request Emergency FDA Authorization for COVID-19 Vaccine

Moderna announced its plan to apply today for emergency FDA authorization for its coronavirus disease 2019 (COVID-19) vaccine candidate, the company said in a press release.

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.

Based on prior analysis, the vaccine is generally well tolerated, with the most common adverse reactions including injection site pain, fatigue, myalgia, arthralgia, headache and erythema/redness at the injection site. Adverse effects increased in severity and frequency after the second dose of mRNA-1273.

According to Moderna, the trial will continue to accrue additional data even after the emergency use authorization (EUA) is submitted.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” Stéphane Bancel, chief executive officer of Moderna, said in a statement. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death.”

Moderna is working with the CDC, Operation Warp Speed, and McKesson to prepare for distribution of mRNA-1273 in the event that it receives EUA from the FDA.

Reference

1. Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with US FDA for Emergency Use Authorization. News release. Moderna; November 30, 2020. Accessed November 30, 2020. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-primary-efficacy-analysis-phase-3-cove-study