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Monday, August 23, 2021

FDA Grants Pfizer COVID-19 Vaccine Full Approval

To those who would not get covid vaccine until FDA approved, now is your chance (Pfizer is FDA approved as of today.) If I were you, I would sign up today for an appointment and ‘beat the rush.’ - Greta Van Susteren.

Seven months after I received the Pfizer vaccine (two separate shots), the Food and Drug Administration (FDA) granted their full approval of the Pfizer vaccine.

According to Fox Business:

The Food and Drug Administration (FDA) on Monday granted full approval to Pfizer's COVID-19 vaccine for individuals 16 years and older.

"The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," Acting FDA Commissioner Janet Woodcock said in a statement issued Monday. "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."

COVID-19 vaccines developed by Pfizer, Moderna and Johnson & Johnson have all previously been granted emergency use authorization (EUA) after meeting the FDA's safety and efficacy requirements. The full licensure announced Monday stems from a so-called biologics license application, building on previously-submitted pre-clinical and clinical data, information relating to the manufacturing process, vaccine quality data and site inspections.

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