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Strategies & Market Trends : 2026 TeoTwawKi ... 2032 Darkest Interregnum

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Nov 19 4:00 PM EST

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From: Julius Wong	11/16/2020 7:44:11 AM
	1 Recommendation Read Replies (1) of 217883

Moderna shares jump 12% as COVID-19 vaccine shows 94.5% efficacy, expects EUA submission in coming weeks Nov. 16, 2020 7:20 AM ET\|About: McKesson Corporation (MCK)\|By: Mamta Mayani, SA News Editor The independent Data Safety Monitoring Board (DSMB) for the Phase 3 study of Moderna's (NASDAQ: MRNA) COVID-19 vaccine candiadte, mRNA-1273, has informed the company that the trial has met the statistical criteria pre-specified in the study protocol, with a vaccine efficacy of 94.5%. The study, known as the COVE study, enrolled more than 30,000 participants in the U.S. This first interim analysis was based on 95 cases, of which 90 cases were observed in the placebo group vs. 5 cases in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001). A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases, all of which occurred in the placebo group. The primary endpoint is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. No significant safety concerns were reported and the vaccine was generally well tolerated. The majority of adverse events were mild or moderate in severity. These data are subject to change based on ongoing analysis of further Phase 3 COVE study data and final analysis. MRNA plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication. Moderna intends to submit for an Emergency Use Authorization (EUA) with the FDA in the coming weeks and anticipates the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months. By the end of 2020, the Company expects to have ~20M doses of mRNA-1273 ready to ship in the U.S. The Company remains on track to manufacture 500M to 1B doses globally in 2021. Moderna recently announced further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure. Shares +12% premarket.

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