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When Placebos are Not Inert
Remember all the times I've said that efficacy trials for vaccines should not allow one vaccine to serve as the comparator of another vaccine?
That happened this week when the FDA sent Moderna a refusal-to-file letter, arguing that the application was not reviewable because Moderna used a standard flu dose as the comparator.
https://drtenpenny.substack.com/p/when-placebos-are-not-inert
Sadly, the FDA folded in 7 days, agreeing to an amended filing by Moderna, so FDA will review the new mRNA vaccine. No way this could be remedied in 7 days.
https://endpoints.news/fda-reverses-course-will-review-modernas-flu-vaccine/