Biotechnology company Moderna Inc (Nasdaq:MRNA) said on Monday that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) has announced a vaccine efficacy of 94.5% following the review of the Phase 3 study of mRNA-1273 against COVID-19.
The DSMB for the company's Phase 3 COVE study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.
Under the COVE study, the company enrolled 30,000 participants in the US. The primary endpoint is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus five cases observed in the mRNA-1273 group.
Based on these interim safety and efficacy data, the company plans to file for an Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least two months). It intends to submit applications for authorizations to global regulatory agencies.
By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the US and remains on track to manufacture 500m to one billion doses globally in 2021.
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