Agenda for Thursday’s meeting on coronavirus vaccine development and approval includes lots of background, which may help public confidence, but not necessarily FDA assessors as they weigh the tough decisions ahead of them.

US FDA drug center is evaluating how to handle the end of the coronavirus public health emergency, which would mean unapproved products would no longer be available, but officials likely have plenty of time to consider options.

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.