The Pfizer / BioNTech COVID-19 vaccinum has received full approval from the US Food and Drug Administration ( FDA ) . The thrust is the first of several being employed underemergency use authorization . The approval will allow schools , universities , government section , and businesses to insist student and staff have had the vaccine .
“ The FDA ’s approving of this vaccine is a milepost as we cover to battle the COVID-19 pandemic . While this and other vaccines have run into the FDA ’s strict , scientific standard for parking brake use authorization , as the first FDA - approve COVID-19 vaccine , the public can be very sure-footed that this vaccinum adjoin the high standard for safety , effectiveness , and manufacturing quality the FDA requires of an approved mathematical product , ” Acting FDA Commissioner Dr Janet Woodcock said in astatement .
“ While meg of people have already safely receive COVID-19 vaccines , we recognize that for some , the FDA approval of a vaccinum may now infuse additional sureness to get vaccinated . Today ’s milestone puts us one step nigher to altering the grade of this pandemic in the U.S. ”
The vaccine is approved for anyone aged 16 years and older and it will be now marketed as Comirnaty ( pronounces koe - mir’-na - tee ) . It will stay available for individuals 12 to 15 under the previous emergency use authorization .
“ Our scientific and medical expert take an incredibly thorough and serious-minded rating of this vaccine . We evaluated scientific information and information let in in 100 of yard of page , conducted our own analysis of Comirnaty ’s safety and effectiveness , and perform a detailed assessment of the manufacturing processes , admit inspection of the manufacture facilities , ” added Dr Peter Marks , director of FDA ’s Center for Biologics Evaluation and Research . “ We have not drop off view that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines . The public and aesculapian community can be confident that although we approved this vaccinum efficiently , it was fully in keeping with our existing high standards for vaccinum in the U.S. "
Since the vaccinum was okay for emergency brake use authorizationover 204 million dosesof vaccinum have been administered in the United States .