The U. S. Food and Drug Administration ( FDA ) has approved the Pfizer - BioNTech Covid-19 vaccine.

Since December 2020 the Pfizer vaccine has been available under emergency use authorization by the FDA and has now been fully approved for use to individuals 12 years of age and over. Acting FDA Commissioner Dr. Janet Woodcock said , " 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 the pandemic in the U.S. " 

FDA vaccines undergo the agency's standard process for reviewing quality , safety and effectiveness of medical products. For ll vaccines , the FDA evaluates data and information included in the manufacturer's submission of a biologics license application. According to the FDA , the public can be very confident that the Pfizer vaccine meets the high standards for safety , effectiveness and manufacturing quality the FDA requires.