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The Food and Drug Administration ( FDA ) granted full approval to Pfizer - BioNTech ’s coronavirus vaccine on Monday ( Aug.23 ) .
That marks the first full approval for a COVID-19 vaccine in the U.S. , and might pave the agency for more vaccine authorisation and ease vexation of those who are unvaccinated .
More than 170 million multitude in the U.S. have already been fully immunize with COVID-19 vaccinum in the U.S. under what ’s known as an emergency use authorizations , a fast - tracked blessing for medical products to be used under emergency scenario , such as apandemic .
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To be granted hand brake favourable reception , the vaccines had to meet a eminent bar . Moderna , Johnson & Johnson and Pfizer - BioNTech had to relegate exhaustive data and essay that they were extremely safe and in effect at protect against COVID-19 before they were granted pinch approval . Trial participants were followed for 2 months after vaccination , to check there were no side gist .
Pfizer - BioNTech was the first COVID-19 vaccinum to be granted an emergency use authorization in December 2020 . Under the pinch approval , more than 92 million people in the U.S. have been fully vaccinate with the Pfizer - BioNTech vaccinum , according to the Centers for Disease Control and Prevention ( CDC ) .
To meet full commendation , the company have to submit a " biologics license app program " that includes at least 6 months of post - vaccination follow-up on clinical tribulation player , more details of the manufacturing process , vaccine manufacture site review and quality trial of sample of the vaccinum .
" We evaluated scientific datum and information included in hundreds of thousands of Page , " conducted their own safety and effectuality psychoanalysis and performed a detailed assessment of manufacturing facilities , Dr. Peter Marks , theatre director of FDA ’s Center for Biologics Evaluation and Research , said in a statementon Monday .
expert think a full commendation might help ease the care of some citizenry who were vaccine hesitant .
" The FDA ’s blessing of this vaccine is a milepost as we continue to combat the COVID-19 pandemic,“Dr . Janet Woodcock , acting commissioner of the FDA , said in the statement . “While million of hoi polloi have already safely incur Covid-19 vaccines , we recognize that for some , the FDA favorable reception of a vaccine may now instill additional confidence to get vaccinated . "
What ’s more , full approval could lead to more vaccination mandates , as many businesses were waiting for full favorable reception before want their employees to be vaccinated , consort to NBC News .
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The full approval for Pfizer - BioNTech includes people 16 years of years or older , but children mature 12 to 15 can still receive the vaccine under emergency sanction . Moderna has also employ for full approval , but Johnson & Johnson has not yet applied ( both have emergency manipulation authorizations ) , agree to NBC News .
The Pfizer - BioNTech vaccinum will now be commercialise as Comirnaty .
Originally write on Live Science .
