Transparency, And A Mirror: US FDA Advice On COVID-19 Vaccine EUAs Finally Published – Twice
Everyone but Donald Trump seems happy that the guidance is finally here, with release appearing to be driven by FDA's disclosure of advisory committee materials.
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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.