Pfizer has received full approval for its COVID-19 jab, boosting confidence in the jab, worldwide
The U.S. Food and Drug Administration approved the first COVID-19 vaccine on Tuesday, which will now see the jab marketed as Comirnaty.
The vaccine has been available under emergency authorisation from the FDA for the prevention of COVID-19 disease in individuals 16 years of age and older.
In a statement from the FDA, the organisation says the vaccine also continues to be available under emergency use authorisation known as EUA, including for individuals 12 through 15 years of age.
EUA will also continue for the administration of a third dose in some immunocompromised individuals.
Today, FDA approved the first COVID-19 vaccine for the prevention of #COVID19 disease in individuals 16 years of age and older. https://t.co/iOqsxXV1fj
“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,”
Acting FDA Commissioner Janet Woodcock, M.D
“Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Since December 11, 2020, the Pfizer vaccination has been available under EUA in individuals 16 years of age and older.
That EUA authorisation was expanded to include those 12 through 15 years of age on May 10, 2021.
If you haven’t gotten vaccinated, please do it now. It could save your life and the lives of those you love. pic.twitter.com/ki39QS4PUx
EUAs can be 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, provided that 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.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products.
