The Pfizer-BioNTech has officially become the first COVID-19 vaccine to receive full approval from the US Food and Drug Administration (FDA). It was initially approved under emergency use authorization, but now that it has received the full FDA approval, many organizations such as schools, universities, and government offices will require students and workers to be fully inoculated before returning to school or work.
Acting FDA Commissioner Dr. Janet Woodcock shared a statement that said: “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
Dr. Woodcock continued: “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The vaccine is currently fully approved for people aged 16 years and older. For those between 12-15, the vaccine is still approved under the emergency use authorization for now. The vaccine will officially be named and marketed as Comirnaty, pronounced koh-mir-na-tee, a name that invokes community, unity, immunity, and RNA.
Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research said: “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.”
Dr. Marks added: “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
Since the vaccine was approved for emergency use, over 204 million doses have been administered in the US. Hopefully the full approval will mean this number will increase significantly.