Today, the Food and Drug Administration formally approved the first COVID-19 vaccine.
This widely anticipated decision replaces the emergency use authorization permitted by the agency last December. 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.
The vaccine will continue to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Emergency use authorizations 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 as long asthe 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.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.”
As of Sunday, 73% of the 18 years or older population has received at least one dose of the Pfizer, Moderna or Johnson & Johnson vaccine. Pfizer’s vaccine has been the mostly commonly administered, accounting for about 56% of the doses administered overall, according to data from the Centers for Disease Control and Prevention.
The result of a person receiving the Comirnaty vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The FDA states that 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 EUA vaccine and is administered as a series of two doses, three weeks apart.
“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,” Woodcock said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The FDA and CDC both have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner.
Learn more about today’s FDA announcement here.