Pfizer and BioNTech Submit Covid-19 Vaccine for FDA Emergency Authorization
Pfizer and BioNTech officially ask the FDA to grant emergency use authorization for their coronavirus vaccine. The request brings the world one step closer to deploying a highly effective shot.
Pfizer and BioNTech formally submit their coronavirus vaccine to the US Food and Drug Administration for emergency use authorization. This historic request comes just days after the companies announce their shot demonstrates 95% effectiveness in preventing Covid-19 infections with no serious safety concerns.
The FDA now faces a tight timeline to review the massive amount of clinical data before a scheduled advisory committee meeting in early December. If the independent experts endorse the application and the agency grants the EUA, millions of vulnerable Americans could receive their first doses by mid-December.
While the submission marks a major milestone in the fight against the global pandemic, health officials caution that the initial supply remains limited. Distribution plans prioritize healthcare workers and nursing home residents, meaning the general public still waits months for widespread access to the vaccine.