Last week the U.S. Food and Drug Administration approved the first COVID-19 vaccine. As of Monday, August 23, the Pfizer-BioNTech COVID-19 vaccine has been approved by the FDA.
“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,” said acting FDA Commissioner Janet Woodcock.
According to the FDA, the Pfizer-BioNTech COVID-19 Vaccine, which will be marketed as Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older, was first authorized back in December for emergency use. This approval pathway was designed to speed up treatments and vaccines to market during a public health emergency.
“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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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 Washington Examiner reports, Moderna, whose vaccine relies on the same mRNA technology as the one developed by Pfizer, filed its application for full approval in June, and it is expected to be granted this fall. Pfizer and Moderna are also in the process of testing the vaccines in young children, with clinical trial data expected to be submitted to the FDA in the fall as well. Read full story here.
