Toby Rogers takes the FDA criminals apart with its fake data collections and plan to avoid clinical trials of COVID vaccines in future. MUST-READ

Who needs data when you’ve got regulatory capture?

https://tobyrogers.substack.com/p/fda-announces-updated-schedule-for?utm_source=%2Finbox&utm_medium=reader2&s=r

 

I. The June FDA meetings

This week the Washington Post
copied and pasted from a Pfizer press release to announce yet another
scientific miracle(TM) that will completely fail in practice. In the
process WaPo also got some quotes from the FDA who have now nailed down
the schedule for the 4 meetings in June in which they intend to assemble
the final pieces for Pharma’s permanent dominance over the American
people.

The new schedule is as follows:

June 7, Novavax
June 14, Moderna in kids 6 to 17 years old
June 15, Moderna in kids 6 months to 5 years AND Pfizer in kids 6 months to 4 years
June 28, “Future Framework” (the plan to skip clinical trials in perpetuity)

There is a lot to parse in the WaPo’s brief article.

Contrary to the breathless headline, they still don’t have any data. 

Pfizer and BioNTech said the 80 percent efficacy finding was preliminary and based on 10 cases
of Covid-19 in the study population as of the end of April. Once 21
cases have occurred, the companies will conduct a more formal analysis
of efficacy… Pfizer and BioNTech said they plan to finish filing data
with the FDA this week — and warned that the efficacy number was fluid because results are still arriving.

Let’s recap how we got here:

🚩 The Pfizer clinical trial in kids under 5 failed in December 2021.

🚩 So Pfizer added a third dose and that trial also apparently failed in February (which is why Pfizer was forced to withdraw its application on February 10).

🚩 Now Pfizer is describing
a jerry-rigged trial of a third dose in 1,678 kids ages 6 months to
four years old. Pfizer did not disclose how the kids were divided
between the treatment and control group so it is impossible to run our
own calculations on efficacy. Out of that sample, 10 developed Covid —
although it is not clear how the 10 were distributed between the
treatment and control group. (I suppose some quant on Twitter will
figure out how to work backwards from Pfizer’s claims to calculate the
numbers in each of these categories but needless to say, this is not the
proper way to do science.) Of course Pfizer also failed to describe the
contents of the “placebo.”

As always with “publication by press release” the announcement raised more questions than answers:


“the efficacy finding was preliminary”; just 10 cases; “the companies
will conduct a more formal analysis” next month; “the efficacy number
was fluid because results are still arriving” — so you’re saying that
these numbers are NOT statistically significant and in fact you have no
valid “results” at all? Got it.

• How exactly will Pfizer double the number of Covid-19 cases in the clinical trial in the next month given that 74.2% of kids already had natural immunity in February which means that nearly 100% of children likely have natural immunity by now?


Also, is the FDA seriously considering basing national policy, that
impacts 18 million children, by relying on a study with only 10 cases?
It appears that the FDA is not even pretending to care about science
anymore.

What’s perhaps most troubling about this so-called
clinical trial is that Pfizer is NOT looking at health outcomes in the
real world (because there are none). Instead, all of their claims are
based on antibodies in the blood. That’s strange because the members of
the FDA’s Vaccines and Related Biological Products Advisory Committee
unanimously acknowledged on April 6
that there are “no correlates of protection” in connection with
Covid-19 shots (this means that there are no valid proxy measures, such
as antibody counts, that can determine whether someone who has received
this shot is immune to the virus or not.)

WaPo dutifully copied Pfizer’s disingenuous description:

While
the adult trials recruited tens of thousands of volunteers and waited
to see if vaccinated people were better protected, the children’s
vaccine trials were primarily designed to measure immune responses using blood tests

No they were not “primarily designed to measure immune responses using blood tests.” The studies were intentionally undersized
to hide harms from the shots in addition to other tricks that they use
to skew the results (such as kicking you out of the trial if you call
911 or go to the emergency room).
But when one shrinks the sample size, surprise! it becomes impossible
to detect actual health benefits from the shots (the signal would have
been tiny if at all, but when one uses a sample that small then any
positive signal can also disappear into statistical insignificance.)

The only
reason Pfizer and the FDA are focused on antibodies in the blood is
because the trial produced NO clinically significant health outcomes (so
they have to invent imagined future benefits by using a proxy measure
that they acknowledge it not valid). In this age group the shot is all risk,
zero benefit (because 100% of kids have natural immunity already and
because the clinical trial showed no real world health benefit).


II. The bigger picture

Tony
Fauci and the NIAID funded the creation of a chimera virus that escaped
a bioweapons lab and killed 6.3 million people worldwide.

Public health authorities have blocked access to safe and effective prophylaxis and early treatment throughout the pandemic in order to create the market for Covid-19 vaccines.

Covid-19
shots skipped essential safety steps (e.g. challenge trials in animals)
and were rushed to market with no long term data.

In
practice the mRNA shots suppress immune function for six weeks after the
first shot, provide about two months of protection against coronavirus,
then efficacy wanes quickly and becomes negative after six months. The
data that pharmaceutical companies submit, and the entire review process
at FDA and CDC, is based on months two to four (what Alex Berenson
calls, “the happy valley”). Meanwhile, these shots cause more side effects than any vaccine ever invented.

Popular support for the current regime
has collapsed. More people have died of Covid under Mr. I Believe the
Science(TM) than under Orange Man Bad. Only hypochondriacs in blue
states seek out additional doses. Meanwhile Sudden Adult Death Syndrome
stalks the true believers. In the past 48 hours alone actor Ray Liotta,
Andy Fletcher of Depeche Mode, British drummer Alan White (from the band
YES), and comedian Phil Butler were all likely killed by Covid-19
shots. It’s impossible to hide all of the bodies at this point.

The
FDA seems to know that their window is closing to implement the Final
Solution. So they are rushing to put the finishing touches on their
plans to inject this toxic junk into the littlest kids in America. The
FDA knows that these shots cannot pass proper regulatory review so
they’ve developed a plan to rig the process in favor of Pharma in
perpetuity. On June 28, the FDA’s “expert advisory committee” will vote
on a “Future Framework” whereby all future (reformulated) Covid-19 shots
will automatically be deemed “safe and effective(TM)” without any
additional clinical trials, on the theory that they are “biologically
similar” to existing Covid-19 shots.

What this means is that by
fall, the Covid-19 shots that they will be injecting into Americans of
all ages will have a new formula that skipped clinical trials
altogether.

Injecting people with genetically modified mRNA that skipped clinical trials is genocide. It’s slower
than the Nazi Final Solution. But it’s genocide all the same. Indeed
the slower pace of the FDA Final Solution (5% to 15% increase in all
cause mortality every year) might be even more lethal in the long run.
It’s sinister af that they are intentionally building in plausible
deniability (‘the FDA said it was safe’) to help the medical establishment feel virtuous while participating in genocide.

I’ll just conclude by saying: be careful what you wish for FDA.
The tide has already turned. The American people know exactly what you
are doing. We have the receipts. It will be relatively easy to secure a
conviction at Nuremberg 2.0 — we literally have you on video committing crimes against humanity. As a reminder, the courts have determined that “I was just following orders” is not a valid defense.

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Anonymous
Anonymous
6 months ago

"FYI'
1.) The 'Biopharmaceutical Industry Provides 75% Of The FDA's Drug Review Budget'. Is This A Problem?

https://www.forbes.com/sites/johnlamattina/2018/06/28/the-biopharmaceutical-industry-provides-75-of-the-fdas-drug-review-budget-is-this-a-problem/?sh=4f563edf49ec

2.) 'A Legacy of Corruption in the FDA and Big Pharma '
https://mises.org/wire/legacy-corruption-fda-and-big-pharma

3.) Learn The Risks!
https://learntherisk.org/

4.) ' 'Congress is owned by Pharma''!
https://finance.yahoo.com/news/congress-big-pharma-money-123757664.html

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