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What full FDA approval of Pfizer's COVID-19 vaccine would mean


What full FDA approval of Pfizer s COVID-19 vaccine would mean
The COVID-19 vaccine from Pfizer and BioNTech could become the first in the United States to receive full FDA approval.
The companies announced Friday they have initiated an application seeking full approval of the vaccine for people 16 and over from the Food and Drug Administration, CNN reports. The vaccine is now being administered under an emergency use authorization, a mechanism to facilitate the availability and use of vaccines during public health emergencies, per the FDA.
Receiving full FDA approval requires six months of safety and efficacy data, as opposed the two months required for the emergency use authorization, according to NBC News. CNN chief medical correspondent Sanjay Gupta stressed Friday this isn t to suggest that data didn t already show the vaccine to be safe and effective or that the process to get the emergency authorization wasn t rigorous, but the bar of data that you now have ....

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