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 its manufacture, and data gathered from its use during the EUA period.
There’s hope that this new full authorization will encourage fence-sitters who have offered up “I’ll wait until it’s fully approved” as an excuse for not yet having gotten the vaccine despite its availability. At the very least, it’s going to be a lot harder for those hesitating to justify their unreasonable and irresponsible stance in the face of the ongoing pandemic.
Comirnarty got flagged for “Priority Review” by the FDA, which essentially means that the administration devoted its full attention to the process in order to expedite it. No word yet on a timeline for Moderna’s approval, but it’s also in the priority review queue.
We’ll be talking to BioNTech CEO and co-founder Uğur Şahin at TC Disrupt 2021 this year, so be sure to check out that virtual event coming up September 21-23.