Moderna To Seek Emergency Use Approval For COVID-19 Vaccine Candidate

(RTTNews) - Moderna, Inc. (MRNA) said it will apply for an Emergency Use approval of its Covid vaccine as the latest study showed that the vaccine candidate is 94.1% effective to prevent Covid-19. The company said there have been no serious safety concerns identified.

The company will file for an Emergency Use Authorization on Monday from the FDA and conditional approval from the European Medicines Agency. Moderna expects shipping of mRNA-1273 to designated distribution points throughout the U.S. once the Emergency Use Authorization is granted.

Moderna said the primary efficacy analysis confirmed the high efficacy observed at the first interim analysis. The primary analysis 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, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.

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.

By the end of 2020, Moderna expects to have approximately 20 million doses of mRNA-1273 available in the U.S. The company said it remains on track to manufacture 500 million to 1 billion doses globally in 2021.

Shares of Moderna, Inc. were up 11% in pre-market trade on Monday.