August 23, 2021 5:58 PM
FDA Approves Pfizer BioNTech COVID-19 Vaccine
(August 23, 2021) – San Miguel County, CO --- This morning, the United States Food and Drug Administration (FDA) approved the first COVID-19 vaccine for individuals 16 years of age and older.
The Pfizer BioNTech was first approved under an emergency use authorization (EUA) in December 2020. It will now be marketed as Comirnaty and involves for a two-dose series for prevention of COVID-19.
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 12 years of age and older.
“The FDA’s approval of this vaccine is a testament to the safety, effectiveness and quality of the life-saving protection,” said Public Health Director Grace Franklin. “While many of our residents have already safely received COVID-19 vaccines, we recognize that the FDA approval of a vaccine outside of the emergency use authorization is an additional step forward and instills added confidence in getting vaccinated.”
San Miguel County Public Health will continue to host vaccine clinics for both Comirnaty (Pfizer) and Moderna in the coming weeks. The next Comirnaty clinics will take place in September:
• Thursday, September 2 - Norwood Public Library from 3:45 to 4:15 pm, bit.ly/norwoodpfizer
• Friday, September 3 – BOCC Meeting Room at 333 W Colorado Ave, Telluride, 2nd Floor from 3 to 5 pm, bit.ly/telluridepfizer
“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.,” said Peter Marks, M.D., Ph.D., director of the FDA Center for Biologics Evaluation and Research.
Moderna's COVID-19 vaccine remains under the FDA's review, but its approval is expected to follow in the near future.