FDA Panel Meets Today; Pfizer Vaccine Could Be Approved In ‘Days To A Week’
Emergency-use authorization (EUA) could come as soon as today, but Peter Marks, the director of the FDA division overseeing vaccines, tempered that outlook Wednesday.
The Hill:
FDA Authorization Of Pfizer Vaccine Will Come 'Days To A Week' After Panel Meeting
Food and Drug Administration (FDA) regulators may not make a decision about authorizing Pfizer's COVID-19 vaccine until next week, according to an agency official. Peter Marks, the director of the FDA division overseeing vaccines, said Wednesday that a decision would come "days to a week" after an agency advisory panel meeting Thursday. (Weixel, 12/9)
USA Today:
Coronavirus Updates: Pfizer Vaccine Reaches Final Review For FDA Authorization As US Nears 290K Deaths
Pfizer's coronavirus vaccine could become first to earn U.S. Food and Drug Administration authorization as early as Thursday. The 17-member independent Vaccines and Related Biological Products Advisory Committee will meet Thursday to review and discuss data from Pfizer and German startup BioNTech on their vaccine, then vote on whether the FDA should authorize it. The companies are requesting an “emergency use authorization,” shy of a full approval. While they have compiled as much short-term safety and effectiveness data as is typical with any vaccine, the process has been compressed. But corners, FDA says, have not been cut. (Aspegren, 12/10)
AP:
Pfizer COVID-19 Vaccine Faces Last Hurdle Before US Decision
The FDA panel functions like a science court that will pick apart the data and debate — in public and live-streamed — whether the shot is safe and effective enough to be cleared for emergency use. The non-government experts specialize in vaccine development, infectious diseases and medical statistics. The FDA is expected to follow the committee’s advice, although it is not required to do so. (Neergaard and Perrone, 12/10)
Stat:
Updates On FDA Panel Meeting On The Pfizer/BioNTech Covid-19 Vaccine
A panel of outside experts is meeting Thursday to consider whether the Food and Drug Administration ought to give an emergency use authorization to the Covid-19 vaccine being developed by Pfizer and BioNTech, a vaccine that appeared to be highly efficacious in a Phase 3 clinical trial. Earlier this week, the United Kingdom started using the vaccine, which is currently known by the working name BNT162b2. On Wednesday, Canada’s drug regulator announced it had approved emergency use of the vaccine. (12/10)
