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FDA grants full approval to Pfizer COVID-19 vaccine

FDA grants full approval to Pfizer COVID-19 vaccine
The Pfizer-BioNTech’s COVID-19 vaccine is now fully approved by the U.S. Food and Drug Administration (FDA). This important progress recognizes the first vaccine to achieve this status. The mRNA-based vaccine has been available to the general public since late 2020 under an Emergency Use Authorization (EUA).

The vaccine is still available under this designation for those ages 12 – 15 until a separate approval process is completed. For those 16 and up, the Pfizer vaccine is now full approved and certified.

“This marks a significant milestone for the COVID-19 vaccine,” Robert Healy, MD, chief medical quality officer, Carle Health said. “This FDA approval means that the vaccine has met every standard set by the administration for safety and efficacy. It certifies what many of us already knew—the vaccine works and is our best tool for staying healthy and limiting the spread of infection.” 

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements.

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

In addition to its approval, Pfizer also shares they will more broadly market the vaccine under the name “Comirnaty”. The FDA and Centers for Disease Control and Prevention monitoring systems ensure that any safety concerns continue to be identified and evaluated in a timely manner.

With the Delta variant causing a surge in cases and hospitalizations nationwide, this important step further emphasizes how critical it is to be vaccinated against COVID-19. 

“We hope that this approval is a clear proof point for those who have yet to receive their COVID-19 vaccine,” Dr. Healy said. “We know it’s safe and we know it’s effective. Now, we know that the Pfizer vaccine has the full approval of the FDA. If you have yet to do so, please go get your vaccine as soon as you can.”

Visit carle.org/covid-19 for more information on how you can receive your COVID-19 vaccine at a location near you.
 

Categories: Staying Healthy

Tags: COVID-19, FDA, pfizer, vaccine

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