Quote:
But historically, Phase III has always been expected by the FDA to take a bare minimum of 1 year.
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one year is not "the rule" it's a guideline for vaccine development when not in a pandemic. the CDC link suggests 300-3000 participants, which you might expect if you don't have so many possible positive results because the studies are not done during a pandemic. but right now we do have plenty of data points. current phase 3 studies include 30,000 participants and more