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# Moderna Submits EUA for Covid-19
- URL: https://www.fdaweb.com/moderna-submits-eua-for-covid-19/
- Published: 2020-11-30T12:00:00.000Z
- Updated: 2026-09-14T16:38:12.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148184

Moderna has filed an emergency use authorization (EUA) for its Covid-19 vaccine mRNA-1273 based on updated efficacy data showing 94.1% vaccine efficacy. The vaccine’s primary efficacy analysis was based on 196 Covid cases, of which 185 were observed in the placebo group versus 11 in the mRNA-1273 group, the company says. A secondary endpoint analyzed severe Covid cases and included 30 severe cases (as defined in the study [protocol](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.modernatx.com%2Fsites%2Fdefault%2Ffiles%2FmRNA-1273-P301-Protocol.pdf&esheet=52339316&newsitemid=20201130005506&lan=en-US&anchor=protocol&index=2&md5=a81b12fc4a8454ab5eb45f8594facb8d&ref=fdaweb.com)) in this analysis. “All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group,” it says, adding that there was one Covid-19-related death in the study to date, which occurred in the placebo group. Moderna says it will also submit data from its Phase 3 COVE study to a peer-reviewed publication.

Additionally, Moderna says FDA’s Vaccines and Related Biological Products Advisory will likely review the safety and efficacy data package for mRNA-1273 on 12/17\. By the end of 2020, the company expects to have about 20 million vaccine doses available in the U.S. It aims to manufacture 500 million to 1 billion doses globally in 2021.

By filing the EUA, Moderna has joined Pfizer in seeking regulatory authorization for a Covid-19 vaccine ([see earlier story](https://www.fdaweb.com/pfizer-biontech-submit-eua-for-covid-19-vaccine/)). Pfizer and its development partner BioNTech submitted their EUA request 11/20 for BNT162b2 based on Phase 3 data showing a vaccine efficacy rate of 95%. Their latest analysis was based on 170 Covid cases, of which 162 were observed in the placebo group versus eight in the vaccine group. The companies say the data demonstrate that the vaccine was well tolerated across all populations in the 43,000-participant trial.