Lagging COVID Antibody Uptake Continues To Worry US Government
US hopes more publicity will boost use of Lilly and Regeneron COVID-19 antibodies, once anticipated to be in short supply, but federal officials lack any other clear strategy to help overwhelmed health systems. Meanwhile Operation Warp Speed is testing the treatments against new virus variants and working on developing antibody cocktails that could avoid escape mutants as FDA issues guidance on potency assays for sponsors.
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The doses of bamlanivimab and etesevimab authorized for use in combination are a fraction of those shown to be effective in the Phase III BLAZE-1 trial; however, Phase II data, PK/PD modeling and in vitro data suggest the lower doses will have the same clinical impact as the higher-dose regimen, the FDA said.
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.
Unused supply for the Lilly and Regeneron therapies has policymakers considering Medicare payment changes for providers managing outpatient infusion, but those may require legislation. National Academies of Sciences, Engineering and Medicine committee considers the ‘paradox of unused supply with a relatively scarce product’ and tries to dissect the challenges that may be contributing to the unexpected lack of take-up for the mABs.