Moderna to file for EU approval of mRNA-1273 vaccine

Modernas primary analysis of the COVE Phase III data was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, pointing to a 94.1% vaccine efficacy. According to the company, 30 severe cases of COVID-19 all occurred in the placebo group. T

The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site.

Moderna said it will submit data from the Phase III COVE study to a peer-reviewed publication.

The primary efficacy analysis confirms the high efficacy observed at the first interim analysis. Based on these results, Moderna plans to request an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA).

The company said it expects to manufacture 500 million to 1 billion doses globally in 2021. The company will supply 80 million doses thereof (and optional 80 million doses later on) to the European Commission, which is resposible for distributing the vaccine to the EU countries.