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chemhokie

Joined: 01/15/2019 Posts: 372
Likes: 431


Typically FDA approval process is...


First drug for any disease must 1) show efficacy, that is there is statistical evidence that is cures, reduces symptoms, or other benefits. 2) it must statistically demonstrate safety, that is it must do less harm that the disease would if left untreated.

For all drugs that follow for that disease they must demonstrate superiority. That requires one or more of the following 1) better efficacy - higher percentage of people receive some benefit from the new drug than the old drug. 2) the safety profile must be better than those drugs that are already approved. 3) in cases where existing drugs may lose effectiveness, such as infectious diseases, it must be at least equivalent for 1 and 2 and have some expectation that it might work when the others don't.

This situation is unusual by all measures. Pfizer and Moderna were approved first and are roughly equivalent. This was third, and meets the criteria, as long as it has good safety. These clots could indicate that it is less safe than the pre-existing vaccines, if so it would typically be pulled from market. However, because this is such an unusual situation what will happen after reviewing the data is anyone's guess. Especially when there is already a large amount of fear and distrust.

(In response to this post by ColoVT82)

Posted: 04/13/2021 at 4:06PM



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Current Thread:
  ...vajayjay ** -- chumley 04/13/2021 6:30PM
  Typically FDA approval process is... -- chemhokie 04/13/2021 4:06PM
  Is that the German vax? ** -- EDGEMAN 04/13/2021 3:47PM
  Astro Zenica? (sp?) ** -- ColoVT82 04/13/2021 4:10PM
  Like 6 cases in 14 million 🤔🙄 ** -- astrohokie 04/13/2021 3:05PM
  Then why suspend it? Something aint adding up. ** -- ColoVT82 04/13/2021 3:08PM
  They are suspending in order to give providers -- No Clue 04/13/2021 4:08PM
  See Fauci. Knows all, 'splains all. ** -- PhotoHokieNC 04/13/2021 4:07PM
  Setting the stage for the new B&J vaccine -- WestyHokie 04/13/2021 3:16PM
  PB&J? ** -- Stork 04/13/2021 3:30PM
  Grape, strawberry, or orange marmalade? ** -- TomTurkey 04/13/2021 3:35PM
  Always strawberry ** -- Stork 04/13/2021 3:38PM
  Patti Labelle likes orange marmalade ** -- TomTurkey 04/13/2021 5:06PM
  They don't inject you with anything so much as they -- ElbertoHokie 04/13/2021 3:21PM
  I might go for 3 doses, just to be sure! ;) ** -- ColoVT82 04/13/2021 3:32PM
  Ayup...4.2857e-7 ** -- Major Kong 04/13/2021 3:07PM

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