"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. (Read More)
