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

JacksinPA · Aug 30, 2020

FDA willing to fast track coronavirus vaccine before phase three trials

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.
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So the FDA is already to cut corners to please Trump. This will provide even less incentive for the first wave of vaccinatees to line up for the shots.

JANFU · Aug 30, 2020

JacksinPA said:
FDA willing to fast track coronavirus vaccine before phase three trials

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.
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So the FDA is already to cut corners to please Trump. This will provide even less incentive for the first wave of vaccinatees to line up for the shots.

A good 35 % of Americans do not trust a vaccine - fastracking it, expect the numbers to jump

CDC, FDA, sidelined.

From what I recall a Civil Servant may have the final say????

I am sure many have not heard of this fellow

Now how he falls in this possible approval, I do not know who has the final say.

Clear that political pressure on Govt officials has been used by Trump since the beginnings of C19, and they cave

WH has made Faucci disaapeared.

Birx- her political Spidy sense warns her, she is truly ffd

https://www.washingtonpost.com/heal...6fb7a0-d8f1-11ea-930e-d88518c57dcc_story.html

Mongidig · Aug 30, 2020

I told you!

It could happen as early as September. A very smart person has told me this.

Chomsky · Aug 30, 2020

If they let this thing out in the wild, before it's been found to have reasonable efficacy, they'll cause even more problems. An ineffectual vaccine is worthless, and can cause a boomerang effect if the recipients drop their high levels of mitigation believing they are now 'immune'.

Chomsky · Aug 30, 2020

Mongidig said:
I told you!

It could happen as early as September. A very smart person has told me this.

I do seem to remember you or someone else making this claim, to be honest.

noonereal · Aug 30, 2020

JacksinPA said:
FDA willing to fast track coronavirus vaccine before phase three trials

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.
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So the FDA is already to cut corners to please Trump. This will provide even less incentive for the first wave of vaccinatees to line up for the shots.

FDA has been corrupted by TRump... that should be the story headline.

noonereal · Aug 30, 2020

Chomsky said:
If they let this thing out in the wild, before it's been found to have reasonable efficacy, they'll cause even more problems. An ineffectual vaccine is worthless, and can cause a boomerang effect if the recipients drop their high levels of mitigation believing they are now 'immune'.

It's a disaster. I can no longer trust any part of my government.

One man, 4 years and 250 years in the ****ter.

Chomsky · Aug 30, 2020

noonereal said:
It's a disaster. I can no longer trust any part of my government.

One man, 4 years and 250 years in the ****ter.

Yeah, but my statement was predicated by 'if'. If they let it out early, and it proves ineffectual (or worse yet, harmful).

Now it is true Scott Hahn is a Trump appointee. But he was appointed late last year, before the pandemic hit. However his role in assisting Trump in promoting Hydroxy is disappointing. But on the flipside he came-out against Trump in Trump's relatively recent statement about '99% of the kids are fine' claim.

So, I'm not sure what to make of the guy.

JANFU · Aug 30, 2020

Chomsky said:
Yeah, but my statement was predicated by 'if'. If they let it out early, and it proves ineffectual (or worse yet, harmful).

Now it is true Scott Hahn is a Trump appointee. But he was appointed late last year, before the pandemic hit. However his role in assisting Trump in promoting Hydroxy is disappointing. But on the flipside he came-out against Trump in Trump's relatively recent statement about '99% of the kids are fine' claim.

So, I'm not sure what to make of the guy.

They are facing hard & public checks on their principles.

One is going public

Other is to mitigate an ongoing disaster and not completely destroy American confidence in their respective agencies

Glad I am not in their position.

Not his enablers, the ones trying to stay relevant

Reason being, regardless whether fact or fiction on their decisions, and all will receive micro scrutiny, one side will pillory, the other defend

Chomsky · Aug 30, 2020

JANFU said:
They are facing hard & public checks on their principles.

One is going public

Other is to mitigate an ongoing disaster and not completely destroy American confidence in their respective agencies

Glad I am not in their position.

Not his enablers, the ones trying to stay relevant

Reason being, regardless whether fact or fiction on their decisions, and all will receive micro scrutiny, one side will pillory, the other defend

After he came out against Trump's claims about infecting the kids, my gut feeling is he will try & do what he believes is right. It'll be a tough call!

JANFU · Aug 30, 2020

Chomsky said:
After he came out against Trump's claims about infecting the kids, my gut feeling is he will try & do what he believes is right. It'll be a tough call!

Me I see them caving and balancing trying to mitigate the disaster from Trumps response to C19

Many will be held accountable, and some will or will not deserve it

Problem is the public will demand blood

I think he and Birx are royally screwed.

Chomsky · Aug 30, 2020

JANFU said:
Me I see them caving and balancing trying to mitigate the disaster from Trumps response to C19

Many will be held accountable, and some will or will not deserve it

Problem is the public will demand blood

I think he and Birx are royally screwed.

I don't see a 'cave'. The pressure will be there, and there will be some influence. But I don't think there will be a wholesale selling-out. But I've misjudged Trump's influence before! (CF Barr)

George50 · Aug 30, 2020

Mongidig said:
I told you!

It could happen as early as September. A very smart person has told me this.

That was reported in the NYT last week.

Sent from my iPad using Tapatalk

JANFU · Aug 30, 2020

Chomsky said:
I don't see a 'cave'. The pressure will be there, and there will be some influence. But I don't think there will be a wholesale selling-out. But I've misjudged Trump's influence before! (CF Barr)

From what I see, I think you are wrong

That's fair

Chomsky · Aug 30, 2020

JANFU said:
From what I see, I think you are wrong

That's fair

Said by a fair poster! :thumbs:

minnie616 · Aug 31, 2020

Chomsky said:
If they let this thing out in the wild, before it's been found to have reasonable efficacy, they'll cause even more problems. An ineffectual vaccine is worthless, and can cause a boomerang effect if the recipients drop their high levels of mitigation believing they are now 'immune'.

I remember in 1976 when President Ford was running for for a new term Swine fle was predicted

to become a pandemic and The administration rushed a vaccine. Not good.

.

The Swine Flu Program was marred by a series of logistical problems ranging from the production of the wrong vaccine strain to a confrontation over liability protection to a temporal connection of the vaccine and a cluster of deaths among an elderly population in Pittsburgh. The most damning charge against the vaccination program was that the shots were correlated with an increase in the number of patients diagnosed with an obscure neurological disease known as Guillain–Barré syndrome (1).

The Public Health Legacy of the 1976 Swine Flu Outbreak | Discover Magazine

I sincerely hope history will not repeated itself by releasing a vaccine with bad side effects because it was rushed once again.

justabubba · Aug 31, 2020

minnie616 said:
I remember in 1976 when President Ford was running for for a new term Swine fle was predicted

to become a pandemic and The administration rushed a vaccine. Not good.

The Public Health Legacy of the 1976 Swine Flu Outbreak | Discover Magazine

sure

FIRST

innoculate all of the trump family, including kids and grandkids

ditto for pence and mother

and the cabinet members starting with mnuchin, pompeo, and devoss

plus the senior staff of the CDC

literally put some skin in the game to show the American public how confident you are in this process

snakestretcher · Aug 31, 2020

JacksinPA said:
FDA willing to fast track coronavirus vaccine before phase three trials

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.
=================================================================
So the FDA is already to cut corners to please Trump. This will provide even less incentive for the first wave of vaccinatees to line up for the shots.

What could possibly go wrong?

snakestretcher · Aug 31, 2020

justabubba said:
sure

FIRST

innoculate all of the trump family, including kids and grandkids

ditto for pence and mother

and the cabinet members starting with mnuchin, pompeo, and devoss

plus the senior staff of the CDC

literally put some skin in the game to show the American public how confident you are in this process

Trump will lie about being vaccinated, just as he lied about taking HCL.

Napoleon · Aug 31, 2020

JacksinPA said:
FDA willing to fast track coronavirus vaccine before phase three trials

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.
=================================================================
So the FDA is already to cut corners to please Trump. This will provide even less incentive for the first wave of vaccinatees to line up for the shots.

The pharmaceutical company would have to request those corners to be cut. Whether any company is willing to take that kind of risk remains to be seen.

Chomsky · Aug 31, 2020

minnie616 said:
I remember in 1976 when President Ford was running for for a new term Swine fle was predicted

to become a pandemic and The administration rushed a vaccine. Not good.

The Public Health Legacy of the 1976 Swine Flu Outbreak | Discover Magazine

I sincerely hope history will not repeated itself by releasing a vaccine with bad side effects because it was rushed once again.

I remember that well! I'm no vaxxer, but that disaster made an indelible impression upon me to never be the first to try a new vaccine. And that's likely the way I'll approach the Covid-19 vaccine. My mind's not absolutely set in stone though, so I'll cross that bridge when I get there. But I surely won't be rushing to the front of the line!

minnie616 · Aug 31, 2020

Chomsky said:
I remember that well! I'm no vaxxer, but that disaster made an indelible impression upon me to never be the first to try a new vaccine. And that's likely the way I'll approach the Covid-19 vaccine. My mind's not absolutely set in stone though, so I'll cross that bridge when I get there. But I surely won't be rushing to the front of the line!

I agree. I am a strong believer in vaccinations but am cautious and want to know it was tested and all steps were taken to make sure it is safe for the public.

Chomsky · Sep 2, 2020

minnie616 said:
I agree. I am a strong believer in vaccinations but am cautious and want to know it was tested and all steps were taken to make sure it is safe for the public.

The Swine Flu fiasco made a lasting impression upon me, that's all I can say. Ford (Pres) was a klutz of the highest order. Couldn't even golf without endangering the public - much less handle a pandemic.

Ethel2 · Sep 2, 2020

minnie616 said:
I agree. I am a strong believer in vaccinations but am cautious and want to know it was tested and all steps were taken to make sure it is safe for the public.

Sign me up for the vaccine. We will know if the vaccine is safe in the short term (months) very soon, and we will know whether or not it is effective within a few months too. The long term side effects will take many more months, maybe years, to discover. I am going to roll the dice a bit to get back to normal. I am 69 years old and my time on the planet is limited. This pandemic is robbing me of time I could spend traveling and scuba diving, visiting family and friends...etc. This decision will be very personal for everyone, but if enough people accept the risk we can get on with "life as normal" through herd immunity via a vaccine.

Unitedwestand13 · Sep 2, 2020

Ethel2 said:
Sign me up for the vaccine. We will know if the vaccine is safe in the short term (months) very soon, and we will know whether or not it is effective within a few months too. The long term side effects will take many more months, maybe years, to discover. I am going to roll the dice a bit to get back to normal. I am 69 years old and my time on the planet is limited. This pandemic is robbing me of time I could spend traveling and scuba diving, visiting family and friends...etc. This decision will be very personal for everyone, but if enough people accept the risk we can get on with "life as normal" through herd immunity via a vaccine.

If the vaccine was fast tracked through phase three of testing out of expediency and the desire to “return to normal” then there is genuine concern that a faulty vaccine will somehow be peddled. Peoples lives depend on a vaccine that actually works rather then the one that is the quickest to made.

I am willing to wait years for a vaccine that is medically sound.

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

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

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