Pfizer’s Bourla: State of US Presidential Transition Not ‘Ideal’ For Vaccine Rollout
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.
You may also be interested in...
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.
COVID Vaccines Getting Parallel Review: ACIP To Begin Process Before FDA Decisions
With goal of distributing vaccines within 24 hours of emergency use authorization, HHS is hoping to convene CDC's ACIP concurrent with the FDA review, Alex Azar says.
Pfizer, Moderna Discussing When To Drop Controls In COVID Vaccine Trials With US Government
Crossover could happen along with the EUAs, Operation Warp Speed's Slaoui says, or when enough high-priority groups are inoculated, or maybe when the vaccines receive full BLA approval. Whatever officials and sponsors decide, it will create challenges for vaccine candidates still in development.