FDA Issues Full Approval for Pfizer Covid-19 Vaccine

SAN ANGELO, TX – For the past seventeen months, the country has grappled with the effects of the coronavirus pandemic affecting every aspect of life. In 2020, Pfizer, Moderna, and Johnson & Johnson began manufacturing and distributing vaccines under an emergency use authorization or EUA. 

Emergency use authorizations are 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 once 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.

On Monday, the FDA announced the Pfizer-BioNTech COVID-19 Vaccine now has full approval for patients 16 and older. 

“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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

The vaccine, which will now be marketed as Comirnaty, contains messenger RNA or mRNA –– which is a kind of genetic material.

The mRNA is used by the body to mimic one of the proteins in the virus that causes COVID-19. As a result, a person's immune system will ultimately react defensively to the virus that causes coronavirus.

Messenger RNA is only present in the body for a short time and is not incorporated into - nor does it alter - the patient's genetic material. 

“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,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “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 the 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."

The approval for teens between the ages of 12 and 15 remains under EUA, as well as the third dose recommended for certain immunocompromised individuals.

To date, more than 51 percent of the American population has been vaccinated against the virus.