Government offers help securing supplies in return for another 100 million doses by Q2. That would mean abandoning Pfizer’s preferred arms-length relationship.

President’s comments follow two revelations: Pfizer’s acknowledgement that it will not meet its previously-stated vaccine production goals for 2020, and the US government’s decide to pass on additional Pfizer doses which have since been allocated to other countries.

Reorganization in January expected to leave CDER’s nine-year-old pharmaceutical quality assessment organization more adaptable to public health emergencies, new pharmaceutical technologies and market dynamics, while further blending approaches to new and generic drug reviews.