BESE votes to keep mask mandate in place despite opposition from citizens
August 23, 2021
Susan Duplantis
August 23, 2021
The Food and Drug Administration (FDA) has granted the Pfizer-BioNTech COVID-19 vaccine full approval in a highly anticipated move that is expected to boost vaccination numbers nationwide.
The Pfizer-BioNTech vaccine, like the other two available in the U.S., had been given emergency use authorization allowing it to be administered only during the 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.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
The full FDA statement can be viewed by clicking here.
