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STEVED00
North Carolina St. Fan
Metairie, LA
Member since May 2007
17702 posts

T/F? No “Approved” Covid Treatments Is/Was Needed for Emergency Approval of Vaccines?
This was mentioned to me and I would like to know if it is true. In order for the powers that be to approve a vaccine for emergency use, there need to be no “approved” treatment options. True or False?



LNCHBOX
LSU Fan
70448
Member since Jun 2009
70536 posts

re: T/F? No “Approved” Covid Treatments Is/Was Needed for Emergency Approval of Vaccines?
FDA website says this
quote:

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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00
Displaced
LSU Fan
Member since Dec 2011
29369 posts

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

Treatment is very vague terminology.


TaderSalad
LSU Fan
mudbug territory
Member since Jul 2014
19680 posts

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


lsupride87
LSU Fan
Member since Dec 2007
74026 posts
 Online 

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

They shite on Trump for suggesting HCQ cocktail. Turns out he was right on that as well
Not really

Bring on the downvotes from hell, I dont give a shite. Im so tired of this HCQ shit

The media was corrupt and evil for touting it as bad, and saying everything they did with HCQ simply because Trump mentioned it. It was horseshite


However, the hospitals and systems Across America used the shite out of HCQ and AZM and it simply didnt really work. It was 100% worth the shot, and Trump said NOTHING wrong at all.

This post was edited on 6/11 at 10:21 am


STEVED00
North Carolina St. Fan
Metairie, LA
Member since May 2007
17702 posts

re: T/F? No “Approved” Covid Treatments Is/Was Needed for Emergency Approval of Vaccines?
From another post in the thread

quote:

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.


Thoughts?


bikerack
USA Fan
NH
Member since Sep 2011
561 posts

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

However, the hospitals and systems Across America used the shite out of HCQ and AZM and it simply didnt really work. It was 100% worth the shot, and Trump said NOTHING wrong at all.


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.

I assume that means they pumped obese people with 5x-10x the normal amount.

I can't find the exact link but this refers to it. Study not yet peer-reviewed...

Twitter

quote:

“A new, not yet peer-reviewed study of HCQ released this month found it, taken with azithromycin, improved COVID-19 survival by nearly 200% in ventilated patients.”


This post was edited on 6/11 at 10:28 am


lsupride87
LSU Fan
Member since Dec 2007
74026 posts
 Online 

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

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
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



bikerack
USA Fan
NH
Member since Sep 2011
561 posts

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

I just don't see how you can throw around phrases such as "it simply didn't work".

One of my best friends (obese) was in bad shape but luckily got HCQ and AZ early on. His doc said it was a miracle he didn't die based on what he was seeing with other patients.

Whatever...
This post was edited on 6/11 at 10:36 am


STEVED00
North Carolina St. Fan
Metairie, LA
Member since May 2007
17702 posts

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



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Weekend Warrior79
LSU Fan
Member since Aug 2014
7961 posts

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


shel311
Nicholls St. Fan
McKinney, Texas
Member since Aug 2004
84862 posts

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

and Trump said NOTHING wrong at all.
I could be wrong but wasn't he touting it as a preventative medication but this new study mentions its usefulness as a treatment?


Weekend Warrior79
LSU Fan
Member since Aug 2014
7961 posts

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

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

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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sgallo3
USA Fan
Dorne
Member since Sep 2008
22932 posts

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


I just don't see how you can throw around phrases suck as "it simply didn't work".


It may work for certain people for a reason that hasn't been discovered yet, but over the large clinical trials they were not able to find a statistical difference between those treated wit hcq and other treatment options. You can get weird results with small sample sizes an non-randomized studies


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STEVED00
North Carolina St. Fan
Metairie, LA
Member since May 2007
17702 posts

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

since COVID affected everyone differently




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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lsupride87
LSU Fan
Member since Dec 2007
74026 posts
 Online 

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

One of my best friends (obese) was in bad shape but luckily got HCQ and AZ early on.
Because for the majority of people, even obese people, you could give them poptarts and sprite as the treatment and they will live. Thats why it was difficult to actually tell if anything was working. Covid is such an overall benign virus its tough to tell

This post was edited on 6/11 at 10:36 am


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lsupride87
LSU Fan
Member since Dec 2007
74026 posts
 Online 

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

I could be wrong but wasn't he touting it as a preventative medication but this new study mentions its usefulness as a treatment?
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
This post was edited on 6/11 at 10:40 am


shel311
Nicholls St. Fan
McKinney, Texas
Member since Aug 2004
84862 posts

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

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

Right, while I certainly agree Trump was needlessly shite on a great deal of the time, I don't think the recent study is the big vindication that this board thinks it is. Like you said, it's a study on ventilated patients, and Trump's talking points on HCQ were more preventative so I fail to see the link there.

Or basically, everyone on both sides overreacting unnecessarily.
This post was edited on 6/11 at 10:44 am


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sgallo3
USA Fan
Dorne
Member since Sep 2008
22932 posts

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


STEVED00
North Carolina St. Fan
Metairie, LA
Member since May 2007
17702 posts

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

lsupride87


Are there other treatments that are effective? It seemed like things were very quickly dismissed or downplayed that seemed promising and very low risk. Just seemed odd why. I know OMB but it seemed like more to it than that.


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