US FDA v. COVID Mutants: Multi-Factorial Assessments Will Determine When Product EUAs Need To Change
Acting Commissioner Janet Woodcock offers hints as to the content of upcoming guidance on how emerging virus variants may impact vaccine and therapeutic development. US may need multivalent vaccine and multiple boosters.
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Modified vaccines targeted at new SARS-CoV-2 variants must generate immune response rates not more than 10% below those of the original vaccine, agency says in one of a suite of guidances on medical product development to address variants.
Former US FDA commissioners say that data for Lilly and Regeneron’s authorized mABs suggesting that reduced viral load correlates with clinical benefit potentially paves the way for emergency authorization or accelerated approval of mABs specifically designed to target emerging variants of the SARS-CoV-2 virus.
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.