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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)

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)

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)

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)