T/F? No “Approved” Covid Treatments Is/Was Needed for Emergency Approval of Vaccines?

FDA website says this

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Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense.

Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below.

Information on terminated and revoked EUAs can be found in archived information.

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They shite on Trump for suggesting HCQ cocktail. Turns out he was right on that as well. Big Pharma needed money though, and HCQ pills are dirt cheap.

From another post in the thread

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FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.

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Thoughts?

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I'll need to find it but I saw something 2 days ago that said when using "weight adjusted" HCQ, studies saw a 200% decrease in deaths

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No

That was a non-controlled study of only 250 people, and they used it during mechanical ventilation.

Already a thread on that if you want to dive in

Thanks for the feedback. Just seems like there could be motivation to down play other treatment options in order not to derail the vaccine getting “emergency use” approval.

Wasn't the biggest issue with the HCQ results was it was found to be effective when used early in the COVID diagnosis; but once patients reached a certain point they didn't have enough time for the HCQ to aide them.

Then the natural argument will be, how do we know that those that recovered from the HCQ treatment would not have recovered naturally anyway since COVID affected everyone differently

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Just seems like there could be motivation to down play other treatment options in order not to derail the vaccine getting “emergency use” approval.

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Kind of like how certain people of influence will shite on and shutdown the J&J vaccine at the first sign of potential issues; yet remain silent when there are any issues/problems with the vaccine that they are directly tied to?

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since COVID affected everyone differently

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Like if you were elderly and/or had a couple co-morbidities it was very dangerous (percentage wise) but if you didn’t have the things mentioned above then it wasn’t that severe (percentage wise)?

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I could be wrong but wasn't he touting it as a preventative medication but this new study mentions its usefulness as a treatment?

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He simply said they are seeing some good results and there is some promise when used early. And at the time, we did think that in the hospital. But after time we saw it wasnt really effective. No harm in his comments, and no harm in trying

However, once Trump mentioned it at all the fricking media went on a war against HCQ

But yes, this study, which isnt really that great anyway, is about giving it to ventilated patients and not early on

Banning HCQ shouldve resulted in some form of punishments. At the time when we had so much uncertainty a doctor shouldve been allowed to prescribe it and people shouldve been allowed to get it. That was all political bs. SAD!