US FDA ‘Flexible’ With Vaccine Safety Data Requirements, CBER’s Peter Marks Says
The median of two months of follow-up is not absolute, but agency flexibility is limited.
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US FDA plans to leverage large safety surveillance databases to make up for the fact that a vaccine authorized for emergency use likely would have only one-quarter to one-half as much safety data follow-up as a typical vaccine licensed under a BLA, says CBER director Peter Marks.