Pfizer’s COVID-19 Vaccine Will Miss US Election, Bourla Clarifies
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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Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.
Pfizer and BioNTech have accumulated enough safety data to submit an emergency use authorization, and Pfizer CEO Bourla says at the Stat Summit that he is ‘comfortable’ US distribution of the vaccine will go well despite the unusually complicated government transition.
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.