Moderna's COVID vaccine scheduled for FDA review on Dec. 17

 

• Moderna (NASDAQ:MRNA) +6.9% post-market after soaring to another all-time high in today's trade, as the company asked U.S. and European health regulators to authorize use of its COVID-19 vaccine, which was shown to be 94.1% effective - with 100% efficacy in preventing severe COVID - in a full analysis of a pivotal study.
• A panel of outside experts advising the U.S. Food and Drug Administration will meet Dec. 17 to review the evidence for Moderna's vaccine and vote on whether to recommend that the agency authorize its emergency use; a similar meeting has been set for Dec. 10 for the Pfizer-BioNTech vaccine.
• It is unclear how long the FDA will take to make a decision on allowing use, but Moderna CEO Stéphane Bancel says it is possible the agency could decide within a few days of the advisory panel meeting, or between Dec. 18-20.
• Both vaccines have shown more than 90% efficacy, and mRNA-1273's less-rigorous distribution and shipping requirements give the Moderna drug a slight edge, though both will be used given current production constraints.
• Moderna's market value has now reached a record $60B, topping pharma heavyweights such as Vertex and Regeneron, even though it has yet to bring a drug to market.
• https://seekingalpha.com/news/3640180-modernas-covid-vaccine-scheduled-for-fda-review-on-dec-17