Jeff Coller, Bloomberg Distinguished Professor of RNA Biology and Therapeutics at Johns Hopkins University, shared a post on LinkedIn:
“Breaking: The FDA just refused to review Moderna’s mRNA influenza vaccine application.
Not rejected on the science. Not rejected on safety. Refused to review.
This morning, Mexico announced a 5-year strategic agreement with Moderna for mRNA technology transfer and domestic manufacturing.
This afternoon, the FDA told Moderna: we won’t even look at your flu vaccine.
Moderna took the extraordinary step of releasing the FDA’s letter publicly. CEO Stéphane Bancel: This decision “does not further our shared goal of enhancing America’s leadership in developing innovative medicines.”
Three weeks ago at Davos, Bancel said the company won’t invest in new late-stage vaccine trials due to U.S. regulatory hostility.
Now we see why.
American technology. American investment. American company.
Going everywhere but America.”
Other articles on OncoDaily.