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Approval of the Pfizer-BioNTech vaccine signifies key achievement for public health

FILE - A medical syringe is shown here.  On Monday, Aug. 23, the U.S. Food and Drug Administration approved the first COVID-19 vaccine.

A press release from the FDA says the vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine and will now be marketed as Comirnaty (koe-mir'-na-tee) for the prevention of COVID-19 disease in individuals 16 years of age and older.

The vaccine also continues to be available under emergency use authorization, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

"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 emergency use authorization 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.

According to the FDA, the Comirnaty vaccine contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19.

The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual's genetic material. Comirnaty has the same formulation as the emergency use authorization vaccine and is administered as a series of two doses, three weeks apart.

"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," 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."


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