The coronavirus just will not die.
“This isn’t confined to a handful of states anymore,” says former US FDA Commissioner Dr. Scott Gottlieb. “It’s going to be difficult now to get this under control.”
The U.S. saw 45,000 new cases just yesterday.
The global number is now up to nearly 10 million infections.
States are starting to pause reopening plans.
The good news is we may be one step closer to a vaccine, as Moderna Inc. (MRNA) advances its late-stage development of its coronavirus vaccine. Better, it just finalized the Phase 3 study protocol based on feedback from the U.S. FDA.
“We look forward to beginning our Phase 3 study of mRNA-1273 with some 30,000 participants in July,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “Moderna is committed to advancing the clinical development of mRNA-1273 as safely and quickly as possible to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease.”
Better, the company and Catalent, Inc., a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at Catalent’s biologics facility in Bloomington, Indiana.
As part of the agreement, Catalent will provide vial filling and packaging capacity, as well as additional staffing required for 24×7 manufacturing operations at the site to support production of an initial 100 million doses of the vaccine candidate intended to supply the U.S. market starting in the third quarter of 2020.
The companies are in discussions to secure fill-finish capacity for continued production of hundreds of millions of additional doses.
If we see successful Phase 3 data, MRNA could become one of the most explosive stocks.
After all, we need a vaccine – and we need it now.