FDA approves Pfizer as first COVID-19 vaccine
After nearly a year of emergency use authorization, the FDA grants full approval for Pfizer’s COVID-19 vaccine.
Today, the U.S. Food and Drug Administration announced that they have approved the first COVID-19 vaccine in Pfizer-BioNTech COVID-19 Vaccine, which will now be marketed for the prevention of COVID-19 disease in individuals 16 years of age and older.
It also continues to be available under emergency use authorization, for individuals 12 through 15 years of age as well as use in the case of a third dose in immunocompromised people.
"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.”
According to a Monday release, FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products.
For more information, visit the FDA’s website.