File photo: Chas Hundley
The U.S. Food and Drug Administration (FDA) today announced full approval of the Pfizer-BioNTech COVID-19 vaccine, which now will be marketed as Comirnaty, for the prevention of the coronavirus in individuals 16 years old or older.
The clinical results of the trial showed the vaccine is 91 percent effective in preventing COVID-19.
The Pfizer-BioNTech vaccine has been available for emergency use authorization in individuals 12 years old or older as of May 10. An FDA press release said official approval of the vaccine means the known and potential benefits of it 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,” acting FDA Commissioner Janet Woodstock said in a prepared statement.
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, Woodstock said.
“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," she said. "Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Comirnaty contains a genetic material called mRNA, which is used by the body to mimic one of the proteins in the virus that causes COVID-19. The result of a person receiving the vaccine is that their immune system ultimately reacts defensively to the virus. The mRNA in Comirnaty only is present in the body for a short time and is not incorporated into, nor does it alter an individual’s genes.
The FDA analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients aged 16 years old and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose.
The most common side effects reported by recipients were swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” FDA Center for Biologics Evaluation and Research Director Peter Marks said.
The FDA evaluated scientific data and information included in hundreds of thousands of pages, conducted its own analysis of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities, Marks said.
“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,” he said. “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 FDA press release can be viewed in its entirety here.
Information on finding a vaccine in Washington County can be found online here or by dialing 211.