Moderna files for EUA of its COVID-19 vaccine candidate, along with new data
Shares of US biotech Moderna (Nasdaq: MRNA) were up 13.3% at $144.00 pre-market today, after it announced that the primary efficacy analysis of the Phase III study of its COVID-19 vaccine candidate mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.
The data analysis indicates a vaccine efficacy of 94.1%. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB).
The company also said it plans to request an Emergency Use Authorization (EUA) from the US Food and Drug Administration and conditional approval from the European Medicines Agency (EMA).
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