16:58 PM

FDA approves Pfizer-BioNTech COVID-19 vaccine


Today, the U.S. Food and Drug Administration approved the Pfizer-BioNTech COVID-19 vaccine, which will now be marketed as Comirnaty. Comirnaty is the first COVID-19 vaccine to be approved for the prevention of COVID-19 disease in individuals 16 years of age and older.

Since Cook Children’s announced a mandatory COVID-19 vaccine, some of you have expressed concern that the vaccine is not approved by the FDA.

Marc Mazade, M.D., medical director of Infection Control at Cook Children’s, hopes this will ease the mind of anyone who was hesitant to receive the vaccine until it was approved by the FDA.

“This is very exciting news. We’ve known for a while how safe and effective this vaccine is because we had so much data to support those claims,” Dr. Mazade said. “Even at the start, when the vaccine received emergency use authorization, there was a tremendous amount of data that showed it was safe and effective. The only reason the vaccine did not get formal approval right away is that the FDA standard process is rigorous and you have to watch patients for a certain number of months after they receive the medication. The FDA does not cut any corners. That’s a standard operating procedure and for good reason. Now, we have so much data. More than 92 million Americans have received the vaccine. We’ve seen excellent results.

“Hopefully now we can reassure folks that were worried that the FDA agrees that the vaccine is safe and it works.”

In a statement, the FDA stressed that their scientific and medical experts conducted an “incredibly thorough and thoughtful evaluation of this vaccine.” The FDA evaluated scientific data that numbered in the hundreds and thousands of pages looking at the safety and effectiveness of the vaccine.

“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.” 

Everyone who is able must receive a COVID-19 vaccine by noon on Sept. 27, 2021, or you will be terminated immediately and you will not receive a PTO payout. You may still apply for a medical or religious exemption, but please do so as soon as possible. For more information, visit the Occupational Health resource page.

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