COVID-19 Vaccines: Can US FDA Complete Assessment In Less Than Six Weeks?
With strong data from Moderna and Pfizer, the projection for an EUA by the end of 2020 still may hold despite holidays and other obstacles to completing the necessary work.
You may also be interested in...
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.
COVID Vaccine Distribution: Pfizer Plans ‘Dry Run’ With Four States
Unflustered by cold-chain complications, Pfizer aims to use it experience in shipping vaccine to its trial sites to show states of different sizes, diversity of populations and immunization infrastructures how best to distribute its product.