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Sun Aug 30, 2020, 02:50 PM

FDA willing to fast track coronavirus vaccine before phase three trials end

Source: CNBC

The chief of the U.S. Food and Drug Administration is prepared to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible, according to an interview in The Financial Times.

Insisting that the move would not be due to pressure from the Trump administration to fast track a vaccine, FDA Commissioner Stephen Hahn told the publication that an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.

"It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application," Hahn told The Financial Times. "If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination."

The comments come a week after the FDA granted emergency authorization of convalescent plasma to treat hospitalized Covid-19 patients, despite concerns among some health officials that data from clinical trials is too weak to support widespread application of the treatment yet. That announcement was on the heels of President Trump accusing the FDA, without any evidence, of trying to hurt him politically by dragging its feet in approving new coronavirus vaccines and treatments.

Read more: https://www.msn.com/en-us/money/markets/fda-willing-to-fast-track-coronavirus-vaccine-before-phase-three-trials-end/ar-BB18wcVF?li=BBnba9O&ocid=DELLDHP



What could go wrong?

42 replies, 2095 views

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Arrow 42 replies Author Time Post
Reply FDA willing to fast track coronavirus vaccine before phase three trials end (Original post)
Yo_Mama_Been_Loggin Aug 30 OP
still_one Aug 30 #1
BKDem Aug 30 #2
Mr.Bill Aug 30 #22
napi21 Aug 30 #3
progressive nobody Aug 30 #4
dalton99a Aug 30 #5
SergeStorms Aug 30 #13
karin_sj Aug 30 #28
llashram Aug 30 #32
yaesu Aug 30 #6
bluestarone Aug 30 #7
SergeStorms Aug 30 #14
bluestarone Aug 30 #15
jrthin Aug 31 #41
BadgerKid Aug 30 #8
Igel Aug 30 #36
roamer65 Aug 30 #9
warmfeet Aug 30 #37
sure why not Aug 30 #10
SergeStorms Aug 30 #11
JustABozoOnThisBus Aug 30 #12
calclar Aug 30 #16
JustABozoOnThisBus Aug 30 #19
Steelrolled Aug 30 #25
calclar Aug 30 #17
Midnight Writer Aug 30 #18
lonely bird Aug 30 #20
Steelrolled Aug 30 #23
NickB79 Aug 30 #35
Steelrolled Aug 30 #21
kacekwl Aug 30 #24
Steelrolled Aug 30 #27
Rebl2 Aug 30 #26
Dios Mio Aug 30 #29
Rebl2 Aug 30 #31
Lonestarblue Aug 30 #30
kimbutgar Aug 30 #33
The Magistrate Aug 30 #34
PSPS Aug 31 #38
truthisfreedom Aug 31 #39
radius777 Aug 31 #40
still_one Aug 31 #42

Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 02:54 PM

1. If they don't finish phase three, and it is not peered reviewed, I don't think they will get many

takers regardless of which side of the aisle

I suspect there probably won't be major safety issues, but the problem will be determining how effective the vaccine is.

Giving someone a vaccine that is not very effective is extremely dangerous because it leads to a false sense of security, and they take unnecessary risks

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 02:55 PM

2. Nope. Nosiree. Trump had nothing to do with this.

Why would you even think that?

Uh, maybe because itís total bullshit?

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Response to BKDem (Reply #2)

Sun Aug 30, 2020, 04:39 PM

22. I tell ya, Trump is brilliant.

He may be the first person in history to make a vaccine responsible for more deaths than the disease.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 03:07 PM

3. Heads of the FDA are still screaming from the pain of their arms being twisted! JA! How many

people does he think will accept this vaccine? People aren't stupid! They know the phase 3 testing is where they confirm no lasting problems from the vaccine in any age group of our population, & that it has the desired immunity in everyone as well.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 03:13 PM

4. This is going to be a huge scary mess.

 

Phrase 3 is the most critical and important.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 03:15 PM

5. Sure enough.

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Response to dalton99a (Reply #5)

Sun Aug 30, 2020, 03:42 PM

13. The past three and a half years...

have not been kind to Donald Trump's beautiful, youthful face, have they? It looks like the entire White House staff has been using his face for a dart board.

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Response to SergeStorms (Reply #13)

Sun Aug 30, 2020, 05:04 PM

28. Pure evil in that face

He is sickening

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Response to dalton99a (Reply #5)


Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 03:16 PM

6. In order to make tRump look good at the order of tRump, remember, every federal agency must be

suspect while tRump is dictator, I won't be taking it if they do.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 03:18 PM

7. Well then

The WHOLE FDA. panel GOES FIRST!!

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Response to bluestarone (Reply #7)

Sun Aug 30, 2020, 03:43 PM

14. And the entire Trump family.

They'd just lie and give them saline solution anyway.

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Response to SergeStorms (Reply #14)

Sun Aug 30, 2020, 03:49 PM

15. AGREE!

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Response to SergeStorms (Reply #14)

Mon Aug 31, 2020, 09:55 AM

41. +1000

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 03:31 PM

8. Well, authorization is technically not approval.

Still, youíve got to wonder what if anything gets overlooked.

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Response to BadgerKid (Reply #8)

Sun Aug 30, 2020, 09:04 PM

36. The way this has worked in the past is straightforward.

Part of the push for fast-tracking dates to Act Up! and the push for AIDS drugs to hit the market as quickly as possible.

It's a question of how many people are hurt by the drugs (and in what ways) versus how many people are hurt by postponing the drugs (and in what ways)--multiplied by some assessment of the likelihood that the drug is useful or not. It's the same for drugs that do pass the full battery of tests.

Once authorization is granted, the usual testing regime continues in any event. And sometimes the final results get the drug pulled from the market. Or regs involving its use get nudged.

A number of the early AIDS drugs were finally taken off the market or drastically restricted. They were bad. On the other hand, that typically happened when something better came along.

I had a nasty allergic reaction to a drug once and was prescribed Seldane to squash the reaction. Throat was swelling shut, bad bruising just from looking at part of my body. Six months later the FDA yanked Seldane's approval. It was killing too many people--stopping their hearts. (Men, mostly, if I remember correctly.) It's an on-going process.

It would be the same with this. If 1000 people are dying per day, but the vaccine only kills 10 per day, which is better? (It's the same calculus we use with other vaccines. They all have some risk. But the benefits outweigh the risk.)

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 03:34 PM

9. Inject Trump and his cabinet first.

Then every Repuke Congress critter.

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Response to roamer65 (Reply #9)

Sun Aug 30, 2020, 09:24 PM

37. In the eyeball, well both eyeballs.

I am on board then.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 03:35 PM

10. Far Out!

What could possibly go wrong?

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 03:37 PM

11. What a surprise.

And Donald Trump had absolutely nothing to do with this, right? I'm not putting anything in my body unless it goes through the full federal approval process, and I'm considered an "at risk" individual.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 03:40 PM

12. It may be reasonable to go ahead with production before trials end.

It's a gamble, but if we start production on a few promising vaccines and stockpile them, we might be in a better position to distribute the vaccine when/if the phase 3 trials prove it's good.

It's a venture with some risk, but it's also risky to wait until all tests are done before starting production.

It's a bet, and if we back the "right horses", lives are saved.

No way I'd distribute the vaccine to the market before trials are done and results published/accepted.

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Response to JustABozoOnThisBus (Reply #12)

Sun Aug 30, 2020, 03:52 PM

16. I thought that kind of scaling up was already happening...

...or is that only taking place with a few of the largest manufacturers??

Seems so long ago (!) when that was announced, I just can't remember.

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Response to calclar (Reply #16)

Sun Aug 30, 2020, 03:58 PM

19. Could be, I hope so, but it would require "authorization" for funding.

As opposed to pre-test approval for general distribution.

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Response to calclar (Reply #16)

Sun Aug 30, 2020, 04:50 PM

25. I think the fed government has been funding all of the leading candidates

to start early manufacturing, and receiving guarantees for "N" hundred million vaccine kits. For sure they have done this for Moderna and the Oxford vaccine.

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Response to JustABozoOnThisBus (Reply #12)


Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 03:57 PM

18. Putin would love to make Americans afraid of vaccines.

It would put millions of Americans at risk if there was widespread mistrust of vaccines.

How could he do that? By having the US Government put out a dangerous untested vaccine.

His overall goal is to destroy trust in American institutions, not only domestically but abroad.


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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 04:14 PM

20. Neither a Russia nor the U.S. has a vaccine

Yes, that is opinion. But developing vaccines takes a long damn time. There is no vaccine for the first SARS. No AIDS vaccine. There was an Ebola vaccine released in 2019.

How many people will get sick from reactions to this vaccine? How many will get the disease anyway despite the vaccine?

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Response to lonely bird (Reply #20)

Sun Aug 30, 2020, 04:46 PM

23. "How many people will get sick from reactions to this vaccine? How many will get the disease anyway"

The initial (small scale) safety and effectiveness trials (phases 1 and 2) were good.

If the large scale trial (phase 3) shows very good effectiveness, and no safety issues, and the pandemic is still harming many, the FDA will consider whether the effectiveness results (so far) outweigh the safety risks (so far). If so, they could give limited approval. The FDA will continue monitoring the 30000 Phase 3 participants, as well as the deployment to the general public after approval (known as phase 4).

I'm excited about the results so far.

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Response to Steelrolled (Reply #23)

Sun Aug 30, 2020, 09:01 PM

35. It only takes a few serious, well publicised adverse reactions

To convince tens of millions to avoid the vaccine. If that happens, it could be worse than waiting the extra few months to see which are the safest.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 04:34 PM

21. Nothing new - this was being discussed many months ago.

I volunteered for the trial but haven't been called. If the numbers are good, I'll be first in line to get it early.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 04:48 PM

24. Does anyone else work at the FDA the CDC ?

No other experts or scientists who know the crap going on at the agencies will to speak up ? Is everyone going to shut up and let the chips fall where they may ? I find that hard to believe and truly sad if correct.

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Response to kacekwl (Reply #24)

Sun Aug 30, 2020, 04:56 PM

27. I expect the FDA is going full steam ahead on monitoring of the trials.

I would hope they focus on that and not politics-driven speculation in the news. If and when the FDA gives approval would be the time for a whistle-blower to speak up.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 04:52 PM

26. I won't be

getting it then. No way they should be doing this.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 05:48 PM

29. He doesn't care if it's effective or safe

the results wouldnít be known until after the election. He is going to force the FDA to make a mess of this but thatís okay as long as it makes him look like a real leader.

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Response to Dios Mio (Reply #29)

Sun Aug 30, 2020, 06:24 PM

31. No he does

not. He doesnít care if it makes people sick or kill them.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 06:08 PM

30. I won't be getting any vaccine that hasn't been fully tested.

I hate having to stay home most of the time, but I would hate being on a ventilator struggling to breathe even more.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 07:45 PM

33. Let MF45 supporters be the guinea pigs and have them take the vaccine first

Because there is no fricking way I would take a vaccine for that administration of fraudsters.

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Response to Yo_Mama_Been_Loggin (Original post)

Sun Aug 30, 2020, 07:49 PM

34. One Suspects The Companies Might Not Be So Keen On That, Sir

Liability could prove a wipe-out....

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Response to The Magistrate (Reply #34)

Mon Aug 31, 2020, 03:01 AM

38. A blanket liability shield is part of their demand in the senate

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Response to Yo_Mama_Been_Loggin (Original post)

Mon Aug 31, 2020, 06:55 AM

39. Play it out. The FDA fast-tracks, there's a bunch of bad reactions to the vaccine,

And the anti-vaxxers win a huge new following. Nothing is accomplished, and covid-19 drags out for another 5 years.

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Response to Yo_Mama_Been_Loggin (Original post)

Mon Aug 31, 2020, 07:38 AM

40. This may be the October surprise.

Trump would do anything to win including twisting the arms of the FDA.

The worst would be if Fauci stands up there and endorses it.

If we don't get ahead of this, it could be like another Comey type event that shifts independents.

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Response to Yo_Mama_Been_Loggin (Original post)

Mon Aug 31, 2020, 12:25 PM

42. Does that mean they will be fast tracking the drinking of bleach also?

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