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Trump Says He Might Reject FDA Recent Imposition of Stricter Vaccine Guidelines

Trump Says He Might Reject FDA Recent Imposition of Stricter Vaccine Guidelines

Dr. Fauci ‘cautiously optimistic’ about vaccine approval before year’s end.

https://www.youtube.com/watch?v=iWtDFnMBAZk#action=share

There have been few clearer signs of the battle between the Deep State and the Trump administration than news and policies related to COVID19.

Recently, the Food and Drug Administration (FDA) indicated that it planned to announce stricter guidelines for the emergency authorization of vaccines. This would mean that any chance of approval for the use of several in the late stages of development before the election would be nixed.

The agency is issuing the guidance to boost transparency and public trust as health experts have become increasingly concerned that the Trump administration might be interfering in the approval process, the paper said.

According to the report, the FDA is expected to ask vaccine manufacturers seeking an emergency authorization to follow trial participants for a median of at least two months after they receive a second vaccine shot. It also said the agency is asking that trials identify a specific number of cases of severe COVID-19, the disease caused by the coronavirus, in patients treated with a placebo.

Clearly, the bureaucrats forgot that President Donald Trump is in charge of the executive branch of government. Trump indicated he is considering rejecting the move…for being a blatant political manipulation.

The FDA has reportedly proposed stricter emergency authorization standards, which are now under review by the White House Office of Management and Budget.

“That has to be approved by the White House,” Trump said of the FDA guidance. “We may or may not approve it.”

Trump also suggested that the FDA’s decision to pursue stricter standards “was a political move more than anything else.”

Four vaccines are now in the final stage of clinical trials in the United States — studies that are designed to determine whether any of the shots are effective at preventing coronavirus infections.

Interestingly, Coronavirus Task Force member Dr. Anthony Fauci indicates he is “cautiously optimistic” about the chances of a vaccine being approved by the end of the year.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, said on Wednesday that he and his team are “cautiously optimistic” about developing a coronavirus vaccine and predict it could be approved in November or December.

“We predict that sometime by the end of this year, let’s say November or December, we will know whether or not these are safe and effective,” Fauci said at a Senate Health, Education, Labor & Pensions Committee hearing.

“Early studies in animals and in human Phase 1 and Phase 2 indicate that individuals induce a response that is comparable to, if not better, than natural infection,” he said. “Right now, doses of this vaccine are being produced so they’ll be ready to be distributed.”

Meanwhile, four vaccine developers are moving forward quickly on Phase III large-scale trials.

Johnson & Johnson on Wednesday announced that it has begun phase three trials of its potential coronavirus vaccine, making it the fourth potential vaccine to begin the late-stage trials in the United States.

The move adds to the array of potential vaccines that are being tested, with the hope that multiple candidates will prove safe and effective and help meet the enormous national and international demand.

While the Johnson & Johnson vaccine is not furthest along in the timeline, trailing candidates from Pfizer, Moderna and AstraZeneca, it does have some potential advantages if it proves safe and effective.

Unlike some of the other potential vaccines, the Johnson & Johnson candidate requires just one dose, not two, which would make a vaccination campaign easier. It also does not require storage at extremely cold temperatures, unlike some of the other candidates.

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Comments

notamemberofanyorganizedpolicital | September 24, 2020 at 5:04 pm

That’s good news Leslie.

Here is some more good news.

Why Black Lives Matter is Helping the Trump Campaign | Larry Elder

https://www.youtube.com/watch?v=aFDnYx5X4Yc

Must see!!!!!

notamemberofanyorganizedpolicital | September 24, 2020 at 5:07 pm

Rand Paul on his heated exchange with Fauci over herd immunity

Go to about 2 minutes 45 seconds in.

https://www.youtube.com/watch?v=sFUyKYxZ2Vk

Democrats claim to be the Party of “Science”. As the upcoming Supreme Court nomination fight will show, they are the Part of the Inquisition. (Scott Atlas did a great job of obliterating the CDC’s Redfield.)

Giving shots to 30,000 people and waiting 6 months for results is fine when you already have another vaccine available. In this case, we have about 1,000 people dying per day and much of the economy shut down. They should only wait 4-6 weeks and get a preliminary idea, and start vaccinating millions.

Really, they should be using challenge testing, where you wait two weeks and expose the volunteers to the virus. After a month you have your result. I have volunteered for both types of tests.
https://1daysooner.org/

    notamemberofanyorganizedpolicital in reply to OldProf2. | September 24, 2020 at 5:27 pm

    On those volunteer tests would they do a group of those 80 years old and older, or others who are known to be as the lowest risk already?

    Ironclaw in reply to OldProf2. | September 24, 2020 at 7:08 pm

    I won’t be participating in a vaccine and neither will any member of my family. There is a reason that vaccines take years to develop and part of that reason is to see what effect they have over time.

      tphillip in reply to Ironclaw. | September 24, 2020 at 7:42 pm

      Never mind the fact that:
      – This the first RNA vaccine being pushed onto the public
      – The previous research and trials of SARV-COV-1 vaccine (Of which the WuFlu vaccine is based on) had a constant problem of prevent infection but harming and killing the patient.

      Doesn’t that give you warm fuzzies?

        notamemberofanyorganizedpolicital in reply to tphillip. | September 24, 2020 at 7:57 pm

        RNA?

        DNA?

          Only one is an RNA vaccine: Moderna.

          It’s the hottest one to me because it is a fairly new tech on top of its potential to treat COVID. However, there should be some caution associated with it. The rest don’t seem like a worry.

          It’s mRNA. All the vaccines for covid-19 are mRNA except for the one from China which uses DNA. In 40 tries, every mRNA vaccine failed the challenge test. The science is well known. The binding antibodies produced by the cells clouds the T-Cell response. If the first 40 tries are an indicator, those who are vaccinated will be about 10 times more likely to die. The effect should last at least 10 years and probably much longer than that. The current crop of mRNA vaccines didn’t pass the challenge test, because it was skipped to save time.

    tphillip in reply to OldProf2. | September 24, 2020 at 7:40 pm

    > In this case, we have about 1,000 people dying per day

    HAHAHAHAHA!!

    That’s such a bullshit number I’m surprised someone who calls himself “oldProf2” would seriously spit that garbage out.

    Free tip: Due to the CDC memo of 2020-03-24 (Where the CDC stated they would not verify state numbers) and the CDC memo of 2020-04-17 (Where the CDC said that if you die and test positive for WuFlu you die of Wuflu) death numbers can **not** be trusted.

    Many states have also been caught inflating the numbers due to the financial incentive to classify anything as WuFlu inflated. Even the CDC admits the “perverse incentive”.

    But hey…Like any professor you have an agenda to push. Facts be damned.

    notamemberofanyorganizedpolicital in reply to TheFineReport.com. | September 24, 2020 at 5:34 pm

    Rats love eating others money.

    Interesting fact posted on another but obscure LI thread.

    “puhiawa | September 20, 2020 at 12:08 am

    The Amish today just held a horse and buggy Trump parade today. I am not kidding. This may be the first time in 200 years they have come out in public for a candidate. That is how serious the Amish take this.”

Well that makes total sense. I mean just because the emergency approval criteria already in place and signed off on by FDA was good enough doesn’t mean …oh wait …

I meant the election procedures, just because the various State Legislatures passed voting laws and they were signed by the governor and in some cases with DoJ oversight doesn’t mean that they are ….never mind.

What will be the next thing that was approved yesterday but needs to be changed in time to affect the election? TDS is beginning to crest and will grow through and beyond election day/week.

Perhaps when congress is done grilling the head of USPS over changes just before the election, they’ll grill the head of the CDC?

Trump has really surprised me with how well he’s handled a lot of the crap being thrown at him.
Yeah I have friends who whine about his tweets, but I remind them about W and his never fighting against the crap that was tossed at him. It stuck and he’s going down in history as mediocre at best.

    notamemberofanyorganizedpolicital in reply to 4fun. | September 24, 2020 at 9:26 pm

    President Trump seems to know so much about human nature that it’s almost scary.

    However, I think most of that is deeply rooted in his Judaeo-Christian Culture grounding.

    Olinser in reply to 4fun. | September 24, 2020 at 9:45 pm

    The thing about Trump that most frustrates me is that last thing you would THINK would be the problem given his past reputation and memes.

    Namely, he is way too slow to fire pieces of trash that are not only incompetent, but actively hurting him.

    He waited WAY to long to fire Comey, Sessions, and he still has yet to fire Wray, Fauci or Redfield.

    Wray should have been fired the second his response to the FISA abuse was to say that people need ‘training’, and that not a single agent was going to be held accountable for criminally LYING to the FISA court.

    Fauci AND Redfield should have been fired the minute the CDC screwed the pooch on the initial testing. Not only were they NOT ready to handle the test load, but their idiotic orders and procedures actively prevented non-CDC labs from conducting tests. OR when they suddenly decided a mask mandate was acceptable and they claimed they just lied about them the first time. That little fascist troll Fauci in particular is responsible for an unbelievable amount of bullshit in our response to this farce.

      You gotta take into account that he is working nearly 20 hours a day, and he still can’t get around to everything.

        Sure but we’re not talking about mid-level staffers or functionaries. We’re talking about the HEADS of the agencies.

        Wray should have been fired the second he made it clear he had no intention of doing ANYTHING about the rampant FISA abuse.

        Fauci and Redfield should have been fired the second the CDC couldn’t fulfill their promises for testing.

All these little Feifdoms are getting too big for their britches.
Not just the FDA.

In short, a few Never-Trumpers at the FDA would be able to stop a useful vaccine until doomsday if they wanted. (provided we actually *do* get a useful vaccine out of this mess) Trump is saying (in his way) that politically motivated blocking of an effective vaccine will be prevented just the same as any politically motivated shoving of an in-effective vaccine, something that everybody (except a few burning hatred twits) wants.

The more Trump politicizes this … the less likely people will take the vaccination. Personally … I don’t trust what Trump says … and only half of what the FDA says.

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