FDA’s Expanded Access Metrics Remain Strong
FDA’s approval rate for expanded access programs over a three-year period has remained consistently high, even while the number of applications has fluctuated.
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US FDA considering approach that is similar to, but more stringent than, influenza strain changes, CBER Director Marks says. Meanwhile, vaccine developers face challenge of when to change antigens to get the best results, NIH’s Graham notes. As FDA and sponsors gain more experience with tweaking the vaccines to account for new coronavirus variants and strains, the process may be expedited further.
New US leadership has a more comprehensive COVID-19 strategy, but that doesn’t mean all the plans are fully fleshed out yet. While Biden team declines to provide any details on what new vaccine dosing strategies they plan to examine, CDC quietly updates its recommendations to allow six weeks between shots.
Proposal, which could be formally endorsed by MedPac this spring, would lower the payment rates for vaccines while simultaneously moving all preventative vaccine coverage to Medicare Part B. Commission signals further cuts to payment rate, through an average sales priced-based methodology that might eventually be recommended.