Today, the U.S. Food and Drug Administration gave full approval to the Pfizer-BioNTech COVID-19 vaccine for those 16 years old and older.
“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 FDA’s approval of the vaccine comes after a clinical trial of 44,000 people, half of whom received the vaccine. To date, more than 200 million doses of the Pfizer vaccine have been administered.
“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 (Pfizer’s COVID-19 vaccine) safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “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."
The Pfizer COVID-19 vaccine is also available under emergency use authorization for those 12 to 15 years old and a third dose for immunocompromised individuals.
The Family Medical Center is administering the Pfizer COVID-19 for those 12 and older. Call the clinic at 307-684-2228 to receive the vaccine.
“If you have been on the fence regarding vaccination, now is the time," said Kristina Duarte, Johnson County Healthcare Center's infection preventionist. "This year’s Delta variant is considerably more contagious than the COVID we saw last year. Last year, every new case of COVID led to two more cases. Each new case of COVID-Delta will lead to eight more cases. We are seeing this in our community as cases are increasing quickly. With full FDA approval, you can feel comfortable knowing that the vaccines have proven to be safe and they do an excellent job of preventing hospitalization and severe illness.”
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