Moderna Announces Plan to Seek EUA for COVID-19 Vaccine Candidate

Announcement comes after phase 3 study results showed the vaccine candidate was 94.1% effective against COVID-19 and 100% against severe COVID-19.

The biotechnology company Moderna announced today that the company will request an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its coronavirus disease 2019 (COVID-19) vaccine candidate.

According to Moderna’s press release, the primary efficacy analysis of the phase 3 COVE study of the COVID-19 vaccine candidate, mRNA-1273, found a vaccine efficacy of 94.1% against COVID-19 and 100% against severe COVID-19.

“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 Stéphane Bancel, chief executive officer, 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.”

The primary analysis was based on 196 COVID-19 cases, of which 185 were observed in the placebo group vs 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1%, according to the release.

A secondary endpoint analyzed 30 severe cases of COVID-19 and found that all 30 cases occurred in the placebo group vs none in the mRNA-1273 vaccine group. There was 1 COVID-19-related death, which occurred in the placebo group.

Also, efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 cases included 33 adults aged ≥65 years and 42 participants who identified as being from diverse communities, including 29 Hispanic or LatinX, 6 black, 4 Asian American, and 3 multiracial participants.

Moderna plans to submit data from the phase 3 COVE study to a peer-reviewed publication, according to the press release.

Moderna also announced that the FDA’s Vaccines and Related Biological Products Advisory Committee meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for December 17, 2020.

The company anticipates that the shipping of mRNA-1273 to designated distribution points throughout the US will occur shortly after an EUA is granted.