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US FDA ‘Flexible’ With Vaccine Safety Data Requirements, CBER’s Peter Marks Says

 
• By Derrick Gingery

The median of two months of follow-up is not absolute, but agency flexibility is limited.

Marks_Peter in basement_1200 - CBER Director - JAMA event 5 October 2020
Relegated to the basement after his previous broadcasting perch became a college classzoom, CBER Director Peter Marks still dispenses wisdom and reassurance. What his new location lacks in ambiance it makes up for in the absence of dog interruptions. • Source: screenshot of JAMA webcast

US Food and Drug Administration officials may allow some wiggle room with the coronavirus vaccine safety recommendations that garnered the ire from the White House in recent days.

The expectation for a vaccine candidate to be considered for an emergency use authorization is that Phase III clinical trials include a median of two months of safety follow-up

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