Pfizer and BioNTech announced on Monday that the companies have won fast-track approval from the U.S. Food and Drug Administration for two coronavirus vaccine candidates who are currently being evaluated in clinical trials.
If the trials go as planned, the companies expect to manufacture up to 100 million doses by the end of the year and possibly more than 1.2 billion doses by the end of 2021.
The two vaccine candidates are currently being evaluated in Phase 1/2 clinical studies in the U.S. and Germany.
The companies expect to start a “Phase 2b/3” trial as soon as this month and anticipate enrolling up to 30,000 subjects.
The Trump administration is aiming to help facilitate the development of a widely available vaccine by the end of the year.
There are now more than 3.3 million positive coronavirus cases in the U.S. and more than 135,000 coronavirus-related deaths, according to a tracker from Johns Hopkins University. The U.S. has a population of roughly 330 million.