COVID-19 Vaccine Gets Full Federal Approval

COVID-19 Vaccine Gets Full Federal Approval

By Dr. Henning Ansorg, M.D., FACP, Health Officer County of Santa Barbara, Department of Public Health

If you’ve been waiting for full federal approval for a COVID-19 vaccine, the wait is over!

The Pfizer-BioNTech COVID-19 vaccine received full approval on August 23, 2021, from the U.S. Food and Drug Administration (FDA) for persons 16+ years of age. The vaccine has been known as the Pfizer-BioNTech COVID-19 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.

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

According to Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research: “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 Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities. 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. 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.”

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products.

Santa Barbara County, please get vaccinated today! Visit https://publichealthsbc.org/vaccine/ to find a clinic near you.