Moderna Files with FDA for COVID-19 Vaccine Emergency Use Authorization

Moderna intends to submit the EUA application today and believes that the FDA’s Vaccines and Related Biological Products Advisory Committee will meet to review the safety and efficacy data package on Thursday, December 17, according to the press release.

Moderna has announced its primary efficacy analysis in the phase 3 COVE study for its coronavirus disease 2019 (COVID-19) vaccine candidate and is filing today with the FDA for an emergency use authorization (EUA), according to a press release.

The primary efficacy analysis, conducted on 196 cases, confirmed the 94.1% efficacy observed in the first interim analysis. This efficacy was consistent across age, race and ethnicity, and gender demographics. The cases included 33 older adults and 42 participants who identified themselves as being from diverse communities (29 Hispanic or Latinx, 6 Black, 4 Asian Americans, and 3 multiracial participants).

The primary endpoint of the COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting 2 weeks after the second dose of the Moderna vaccine. In the primary analysis, 185 cases of COVID-19 were observed in the placebo group compared to 11 cases observed in the group that received the vaccine.

A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases. All 30 occurred in the placebo group and none in the vaccinated group. To date, there has been 1 COVID-19-related death in the study, which occurred in the placebo group.

“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,” said Stephane Bancel, chief executive officer of Moderna, in the press release. “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 intends to submit the EUA application today and believes that the FDA’s Vaccines and Related Biological Products Advisory Committee will meet to review the safety and efficacy data package on Thursday, December 17, according to the press release.

REFERENCE

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. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-primary-efficacy-analysis-phase-3-cove-study. Accessed November 30, 2020.