An FDA advisory committee will meet next month to discuss an emergency use authorization.
The emergency use authorization would be for Pfizer's COVID-19 vaccine.
Earlier this week, Pfizer said clinical trials had shown its vaccine to be 95% effective.
"While we cannot predict how long the FDA's review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner," FDA Commissioner Stephen M. Hahn
In October, the Emergency Care Research Institute warned against releasing a vaccine.
They said six months of follow-up data on clinical trial participants is needed to move forward.