US FDA’s COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved
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.
You may also be interested in...
India expert panel decides not to back Lilly’s bamlanivimab as a COVID-19 therapy, at least for now, under the accelerated approval route and without local trials, but the US firm is still pursuing an authorization request. Physicians underscore the need for more data on important patient outcomes for the antibody product.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Operation Warp Speed chief scientific advisor confirms doubts about the Phase III data from two UK and Brazil studies; says efficacy results in US trials of AstraZeneca and Janssen vaccines expected by mid-January.