If you were waiting to get vaccinated because it wasn’t FDA approved, there’s nothing stopping you now. As of August 23, the Pfizer-BioNTech vaccine, now marketed as Comirnaty, is approved by the Food and Drug Administration for use as a COVID-19 vaccine.
The vaccine has been safe to use for those older than 16 since it’s emergency use authorization on December 11, 2020, according to the FDA. Further use for those aged 12 to 15 was given by the FDA on May 10, 2021. Emergency use authorization, or EUA, is permission given by the FDA to medical products during a public health emergency. These products and treatments, like the COVID-19 vaccines, can be used provided the FDA can determine that the benefits of a product outweigh the known and potential dangers.
“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 Dr. Janet Woodcock in an FDA press release detailing the vaccine’s approval.
Having FDA approval means that the Comirnaty vaccine has met the same standards as any other FDA approved vaccine. The FDA requires a biologics license application, or BLA, which is a detailed document containing information like clinical trial data, manufacturing specifications, vaccine testing results, and inspections of where the vaccine is made. Much of this information was part of the emergency use authorization, according to the FDA.
“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 Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in a FDA press release.
Cormirnaty is an mRNA vaccine, which means that it doesn’t contain a dead or weakened form of the COVID-19 virus. Rather it delivers a set of instructions on how to build a copy of a protein unique to the virus. Your body creates the protein, and then your immune system destroys it, and remembers how to recognize and destroy the coronavirus. The FDA assures that the mRNA present in the vaccine does not linger or alter your genetic material, it doesn’t have the ability to do so.
Despite the unique circumstances surrounding its use, the Corminaty vaccine is not lacking in any way compared to any other vaccines approved by the FDA.
“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.” Marks said.
By Mike Flunker, Editor-in-Chief