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Last year, the US FDA issued an "Emergency Use Authorization" for Pfizer-BioNTech vaccine for Covid-19.

I read the wikipedia page on what that means, and it seems as though this can be issued under very lax conditions (e.g. human use after animal-only experiments). On the other hand, I know that the Pfizer-BioNTech vaccine passed "Phase III" trials.

What is missing, therefore, for the vaccine to qualify for "regular" FDA approval? Is it a longer period of time for evaluating the possibility of unexpected mid/long-term detrimental effects in vaccinated patients? Are there additional missing experiments/trials? Or perhaps just administrative procedures?

PS - I've gotten (both doses of) this vaccine already, so please don't mistake this question to about whether or not to get vaccinated.

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  • Basically the threshold of evidence required for approval by the FDA for emergency use is lower than what they would otherwise require for such an approval. This authorization is contingent and does not represent standard "approval". Section 564 of the Federal Food, Drug, and Cosmetic Act details the procedures and requirements the FDA must use to grant EUA. Mar 24 at 1:51
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Well, it turns out I was wrong: The Pfizer-BioNTech vaccine's Phase 3 trials have not been completed: US Government listing of the trials. They will not be over before 2023...

The FDA approval requirements/process is summarized as follows:

  1. An Investigational New Drug application
  2. Pre-licensure vaccine clinical trials
  3. A Biologics License Application (BLA)
  4. Inspection of the manufacturing facility
  5. Presentation of findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC)
  6. Usability testing of product labeling

it seems the vaccine is (as of March 2021) in step 2 of the above. Although it theoretically may have already cleared steps (3.), (4.) and (6.) independently. Perhaps others can shed light on this point.

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  • So, there is some reasonable degree of uncertainty as to the safety of the vaccine at least until Phase 3 trials have been completed, in the eyes of the FDA?
    – Don Slowik
    Jul 24 at 17:33
  • How reasonable the delay, and its importance, is discussed well here nytimes.com/2021/07/21/briefing/…
    – Don Slowik
    Jul 24 at 18:00

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