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Pfizer COVID-19 Vaccine gets Full FDA Approval for Individuals 16+

The U.S. Food and Drug Administration (FDA) has given full approval to the Pfizer-BioNTech COVID-19 Vaccine. The approval is for individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“We recognize that for some, the FDA approval of a vaccine may now give some additional confidence to get vaccinated,” Jeff Kuhr, Director of Public Health for Mesa County said. In Mesa County, 52% of total doses administered have been the Pfizer-BioNTech mRNA vaccine. Moderna also an mRNA vaccine accounts for 36.4%, and Johnson & Johnson (J&J) a viral vector vaccine accounts for 6% of total doses.   

Residents at the Community Vaccination site at Mesa County Public Health can choose which vaccine they receive by scheduling an appointment. More than 134-thousand doses of all vaccine types have been administered in Mesa County, with an estimated 45% (44.76%) of residents being fully vaccinated defined as receiving both doses in a two-dose series, or a single dose of the Johnson & Johnson vaccine.

Full approval signifies a key achievement for public health. In a media release from the FDA, the acting commissioner of the agency, Janet Woodcock, M.D. said, “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.”

According to the FDA, the Pfizer vaccine 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.

Since December 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older. The authorization was expanded to include those 12 through 15 years of age in May 2021. The Moderna and Johnson & Johnson vaccines remain authorized for use in those 18 years and older under EUA.

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.