Moderna Inc. (NASDAQ: MRNA) shares continued to run higher on Monday after the company announced an update for the primary efficacy analysis for its late-stage coronavirus vaccine trial. The biotechnology company also noted when it plans to meet with the U.S. Food and Drug Administration (FDA) for regulatory approval.
The primary efficacy analysis comes from the Phase 3 study of mRNA-1273. The data analysis indicates a vaccine efficacy of 94.1%, and the safety data is continuing to roll in as it is being monitored by an independent, NIH-appointed Data Safety Monitoring Board.
The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the United States. The primary endpoint of this study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine.
The vaccine’s efficacy was demonstrated at the first interim analysis with a total of 95 cases based on the pre-specified success criterion on efficacy. So far, the primary efficacy analysis has been based on 196 cases.
Of these 196 cases, 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%.
Separately, Moderna announced that it plans to request an Emergency Use Authorization (EUA) from the FDA and conditional approval from the European Medicines Agency (EMA). The company already has started the regulatory process with other governing bodies across the globe.
Moderna noted that the FDA’s Vaccines and Related Biological Products Advisory Committee meeting to review the safety and efficacy data package for mRNA-1273 likely will be scheduled for Thursday, December 17.
Moderna stock traded up 16% at $147.38 just after Monday’s opening bell, in a 52-week range of $17.68 to $149.00. The consensus price target is $112.87.