Pfizer-BioNTech vaccine approved by FDA Monday

The vaccine is still available under emergency use authorization for individuals 12-15 years old.

The Pfizer-BioNTech vaccine was approved by the U.S. Food and Drug Administration Monday, Aug. 23. It is the first COVID-19 vaccine to gain approval, and will be marketed under the name Comirnaty.

Currently, it is only approved for those aged 16 and older, however, the vaccine is still available under emergency use authorization for individuals 12-15 years old.

Acting FDA Commissioner Janet Woodcock, M.D. stated the FDA approval of a vaccine instills confidence in those who may have been hesitant to receive it.

“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,” she stated.

Pfizer’s approval was announced the same day Richland County, North Dakota, moved from a moderate to substantial transmission level to a high transmission level, according to Health Services Director Kayla Carlson. The county jumped from five COVID-19 cases to 25 cases over the last week.

The Richland County Health Department will be hosting a COVID-19 walk-in vaccine clinic from 8:30 a.m.-6:30 p.m. Wednesday, Aug. 25.

“Today’s announcement that the Pfizer-BioNTech vaccine meets the FDA’s high standards for full approval instills further confidence that the vaccine is safe and effective and helps address vaccine hesitancy related to the emergency use authorization,” North Dakota Gov. Doug Burgum stated in a release. “Individuals who still have questions or concerns about the vaccines are encouraged to visit with their doctor or medical provider.”

Wilkin County, Minnesota, is currently listed at a substantial transmission level, according to the Centers for Disease Control and Prevention. Wilkin County Public Health vaccination clinic days vary. Interested individuals can call public health at (218) 643-7122 from 8 a.m.-4 p.m. Monday-Friday.

“The FDA’s approval of Pfizer’s COVID-19 vaccine is exciting news. This vaccine is safe, it’s saving lives, and now it’s fully approved,” Minnesota Gov. Tim Walz stated in a release. “Today’s action gives Minnesotans additional assurance that the Pfizer vaccine is safe and effective. Along with vaccines from Moderna and Johnson & Johnson, these are the best tools we have in our fight against COVID-19. If you haven’t yet, now is the time to roll up your sleeves and get your shot.”

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