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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.
There are 18 people on the committee that will issue the first recommendations on COVID-19 vaccine development and licensure. Among the experts are a University of Michigan epidemiologist who will serve as acting chairman and seven temporary voting members, two of whom required conflict-of-interest waivers.
Vaccine experts, including R&D leaders at Pfizer and Sanofi, describe what has been unique in developing a vaccine for the novel coronavirus, lessons learned from previous vaccines, and challenges that lie ahead.
EUA request for COVID-19 vaccine is unlikely before late November; the CEO’s frequent comments that the timetable isn’t politically motivated are unusual to say the least.
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