
After Phase III The Approval And Licensure Phase Begins
Once the scientists are confident that their three phases are complete, they will focus on finishing up any reports and then send these along with any other paperwork and requirements to the FDA. This is when the Biologics License Application comes into consideration, and the FDA starts the other part of their process to ensure that everything is holding firm, guidelines are met, the vaccine does what it’s supposed to do, and safety is achieved.
The FDA inspects everything from the vaccine to the factory and laboratory that developed it. This approval is necessary as once the FDA approves the factory and lab, the scientists can start focusing on developing more of the vaccine for production. In other words, nothing more can be done until the vaccine is ready for the labeling process.