COVID Vaccines: Is Expanded Access A Better Option Than Emergency Use Authorization?
Given concerns about completing Phase III trials, advisory committee member asks whether US FDA has considered ‘the possibility of an expanded access protocol,’ but agency official points to added complexity that comes with the pathway; bioethics experts talk to the Pink Sheet about pros and cons of expanded access vs. EUA pathways.
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Patient confidentiality and trial blinding precluded a Janssen official from sharing specifics about the safety event that led to a study enrollment pause, but Advisory Committee on Immunization Practices representatives say the lack of detailed, publicly disclosed information is not helping vaccine confidence.
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