FDA fully approves Pfizer-BioNTech’s COVID-19 vaccine
https://techcrunch.com/2021/08/23/fda-fully-approves-pfizer-biontechs-covid-19-vaccine/
The U.S. Food and Drug Administration (FDA) has granted full approval to Pfizer-BioNTech’s COVID-19 vaccine, making it the first vaccine to achieve that status. The mRNA-based vaccine has been available since late last year through an Emergency Use Authorization (EUA), and will continue to be offered under that designation for those aged 12 to 15 until that separate approval process goes through, but the U.S. drug regulator now recognizes the Pfizer vaccine as fully approved and certified for adults 16 and up.
Part of receiving the approval means that Pfizer and BioNTech can now officially market their vaccine in the U.S., and the FDA revealed it’ll be offered under the trade dress ‘Comirnarty,’ which doesn’t strike me as particularly catchy but at least it’s less of a mouthful than ‘the Pfizer-BioNTech COVID-19 vaccine.’ FDA approval also means that the vaccine has met all of the administration’s standards for safety and efficacy, including preclinical and clinical trial data, as well as information about tits manufacture, and data gathered from its use during the EUA period.