Moderna said today it will seek FDA emergency use authorization (EUA) and a European conditional approval of its COVID-19 vaccine candidate, after confirming the efficacy of mRNA-1273 with additional positive Phase III data released this morning.
The company cited a primary efficacy analysis by the study’s independent, NIH-appointed Data Safety Monitoring Board (DSMB) of data from the 30,000+ patient Phase III COVE trial (NCT04470427), an analysis based on 196 cases of COVID-19. Of those cases, 185 were seen in patients randomized to placebo, and the other 11 in patients randomized to mRNA-1273.
