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Mon Aug 24, 2020, 02:39 PM

U.S. Authorizes Plasma Treatment for Virus, but the Big Prize for the White House Is a Vaccine

Source: The New York Times

Trump administration officials met with congressional leaders last month and told them they would probably give emergency approval to a coronavirus vaccine before the end of Phase 3 clinical trials in the United States, perhaps as early as late September, according to two people briefed on the discussion.

The move would be highly unusual and would most likely prompt concerns about whether the administration is cutting corners on approvals for political purposes.
...
Dr. Anthony S. Fauci, the infectious disease expert who serves on the coronavirus task force, has said early next year is the most likely timing.
...
One senior administration official who was briefed on the meeting said neither Mr. Meadows nor Mr. Mnuchin had suggested a vaccine could be approved as early as late September. The official was adamant that the administration would not approve a vaccine solely on the basis of foreign clinical trials.

Read more: https://www.nytimes.com/2020/08/23/world/covid-19-coronavirus.html



Clearly Trump is pressuring the FDA to fasttrack an untested (and potentially dangerous) vaccine as his 'October suprise', to save his sinking campaign.

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Response to radius777 (Original post)

Mon Aug 24, 2020, 02:42 PM

1. I've been calling it since the pandemic began that's his "October surprise".

And you can bet that his followers will buy it, even though they are largely anti-vaxxer.

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Response to Initech (Reply #1)

Mon Aug 24, 2020, 02:56 PM

4. I doubt very few people will get it unless it has the backing of Fauci or someone with

credibility

Not on the word of this bunch of deplorable misfits


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Response to still_one (Reply #4)

Tue Aug 25, 2020, 06:50 AM

8. I worry about Fauci, he's another Mueller,

in that we all see him as part of the resistance, but at the end of the day he's simply another establishment white guy.

Fauci has not fully rejected the idea of a fasttrack vaccine, only that 'it depends on the data'.

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Response to radius777 (Reply #8)

Tue Aug 25, 2020, 07:43 AM

9. He is not another Mueller, and your characterization of him as another "establishment white guy"

is nonesense

You obviously do not know his history or background

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Response to still_one (Reply #9)

Tue Aug 25, 2020, 08:21 AM

10. Mueller has a great background also.

Both men have served the country with integrity.

However, both are easily bullied and played by the likes of Barr and Trump.

Fauci should denounce any attempt to fasttrack some vaccine for political purposes - he has not done that - which means we should not be surprised if he suddenly appears on a podium with Trump a week before election day 'praising Mr. Trump's leadership in delivering us this vaccine'.

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Response to radius777 (Reply #10)

Tue Aug 25, 2020, 09:06 AM

11. Fauci does not work for Trump. He works for the NIH, and he will go by the data. There is no

way that Fauci will recommend a vaccine that has NOT completed phase 3, and has demonstrated safety and at least 50% efficacy

Fauci is not influenced by politics. He views are science driven

Fauci warns against emergency coronavirus vaccine approval before widespread testing

Anthony Fauci, the nation's top infectious disease expert, is warning against prematurely distributing a potential coronavirus vaccine through emergency use authorization, saying it could negatively harm the testing for other vaccines.

“The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorization) before you have a signal of efficacy,” Fauci, a key member of the White House coronavirus task force, said in an interview with Reuters.

He added that “one of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial."

Fauci warns has also come out against premature authorization of a vaccine

https://thehill.com/policy/healthcare/513497-fauci-warns-against-emergency-coronavirus-vaccine-approval-before

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Response to still_one (Reply #11)

Tue Aug 25, 2020, 11:53 AM

12. But Fauci is open to a EUA vaccine based on foreign trials.

In the Financial Times article (behind paywall, may allow few free articles) the comments he made seemed more open to supporting a EUA if the UK/AstraZeneca trials shows him what he needs to see. And he and NIH Director Francis Collins vouched for Trump's vaccine czar Moncef Slaoui ('warp speed' clown), whereas before they had seemingly been critical of him.

IMO, Fauci and Collins should plainly state that large (30,000 people) phase-3 trials in the US should be carried out, and anything less is unacceptable. This would prevent any EUA vaccine (based on foreign trials of 10,000 people) from possiby affecting the election and politicizing the vaccine, also to ensure full safety of the vaccine.


This interview with Collins clearly shows he embraces the fasttrack idea, even while saying it is unlikely (but unlikely is not impossible) to happen before the election:
https://www.pmlive.com/pharma_news/covid-19_vaccine_approval_unlikely_before_november,_says_us_nih_director_1346891
In an interview with reporters, Collins said even the most promising coronavirus vaccine candidates will not win approval any earlier than November or December, and added that testing a vaccine in at least 10,000 people could potentially provide enough data to support wide-scale distribution.

“I would not expect, on the basis of what we know scientifically, that we would be at the point where the US Food and Drug Administration could make such a judgment until considerably later than 1 October,” said Collins, adding: “Maybe November or December would be my best bet.”

The Trump administration-backed Operation Warp Speed initiative aims to deliver 300 million doses of a COVID-19 vaccine to the American public by January 2021.
...
Last week, President Donald Trump announced that it was possible a coronavirus vaccine would be available in the US before the start of the general election on 3 November. However, Collins dismissed concerns that Operation Warp Speed is advancing candidates too quickly without determining safety and efficacy first.

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Response to radius777 (Original post)

Mon Aug 24, 2020, 02:46 PM

2. NYT is setting up a straw man argument, there is no vindication with a vaccine

It's all been so bungled it's irretrievable for Trump .... incompetence cannot be erased with lucky timing ... you know any quick vaccine will be a FAKE VACCINE ... because Trump is a FAKER .... a liar, a cheater, con man manipulator .... this is the way more than half of America is seeing this now.

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Response to radius777 (Original post)

Mon Aug 24, 2020, 02:54 PM

3. Before phase three is completed? F**K THEM. If anyone deserves to be prosecuted for crimes

against this American people, they do

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Response to radius777 (Original post)

Mon Aug 24, 2020, 05:32 PM

5. President Pumper-Dumper

First it was Kodak.

Today, a few stocks for plasma companies rocketed in pre-market, and came crashing down. Gonna be a bunch of bag-holders.

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Response to radius777 (Original post)

Mon Aug 24, 2020, 05:46 PM

6. Following Putin's lead? It's not going to work.

Why?

1. Even most Trumpites knew that drinking bleach was a very bad idea, so most of the nation knows he can't be trusted to 'prescribe' a treatment or vaccine.

2. A sizeable percentage of Americans are hesitant about getting the Covid vaccine that will emerge after all the required testing and approvals. They are surely not going to run out and be injected with one that has not been properly tested.

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Response to radius777 (Original post)

Mon Aug 24, 2020, 07:59 PM

7. Doesn't Trump already have a vaccine?

Doesn't Trump already have a vaccine?

He took hydroxychloroquine for two or three weeks as a preventative measure.

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