During a press conference on Saturday, Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn reassured Americans that Pfizer's Wuhan coronavirus vaccine "meets the FDA's rigorous standards for safety and effectiveness."
Hahn dubbed the authorization a "significant milestone" during a trying time.
"Our action comes as that we are near the end of what has truly been a year unlike any other in modern times. While this year has been marked by tragedy, sadness, and sacrifice, it is also a year that has generated unparalleled scientific achievement that will resonate for many future generations," he explained.
The FDA commissioner reminded Americans that a "historic partnership" between the private sector, researchers, and the federal government led to the vaccine that's about to be distributed to Americans nationwide.
Although the vaccine was developed in record time due to the public-private partnership, Hahn insisted that no corners were cut.
"Let me be clear: efficiency does not mean any cutting of corners. Medical products are still undergoing rigorous study and clinical trials," he explained. "Important safety checks remain in place. The FDA's review teams continue, as they have always have done, to comb through the data submitted by companies regarding their medical products. What's different during COVID-19 is that developers, researchers, and regulators have found new and hopefully lasting ways to be dynamic and efficient."
Hahn stated rolling back red tape – when possible – has allowed the vaccine to be created in record time. The number one way that has been achieved is through the utilization of the Emergency Use Authorization (EUA) created by Congress to provide the FDA "with the means to respond rapidly during a public health emergency."
The FDA Commissioner went on to say that he would get the vaccine, a sign of his confidence in the process.
"I will absolutely take this COVID-19 vaccine, pending availability and distribution, because I have complete trust and confidence in the FDA's career staff's evaluation," he said.
FDA Commissioner Dr. Stephen Hahn explains the “historic partnership” that created the COVID vaccine. pic.twitter.com/jL262imH5F
— Beth Baumann (@eb454) December 12, 2020
Hahn signed an emergency use authorization for the vaccine late Friday night. The vaccine was developed in a partnership between Pfizer and BioNTech and had an efficacy rate of 95 percent. Pfizer is currently working with the federal government to get 100 million doses distributed by March.