In a rather shocking turn of events, the U.S. Food and Drug Administration sneaked in a “Future Framework”1
scheme that will allow Pfizer and Moderna to reformulate and release
updated COVID shots without conducting any additional human clinical
trials, other than what’s already been done.2,3,4
FDA Rewrites the Rules on the Fly
A vote on the Framework was scheduled to be taken June 28, 2022, by
the FDA’s Vaccines and Related Biological Products Advisory Committee
(VRBPAC), but while the VRBPAC approved (19-2) a bivalent COVID shot for
fall 2022,5 the expected voting on the Framework, specifically, didn’t seem to take place — only it DID.
As it turns out, we’ve been bamboozled yet again by an agency that
keeps rewriting the rules on the fly. Toby Rogers, Ph.D. — a political
economist whose research focus is on regulatory capture and Big Pharma
corruption6 — explains how they sneaked this one by us:7
“Yesterday [June 28], the FDA’s Vaccines and Related
Biological Products Advisory Committee approved a bivalent COVID-19 shot
with the Wuhan strain and the Omicron variant ...
At the meeting, the manufacturers (Moderna, Pfizer, and Novavax) were asked what their production timelines are… and they said out loud, ‘So long as we don’t have to provide any clinical data, we’ll have them ready by fall.’ No one had a problem with that ...
Wait, hold up, I thought the FDA was voting on the
Future Framework yesterday? The policy question was whether reformulated
COVID-19 shots would be treated as new molecular entities (which they
are) in which case they should be subject to formal review or whether
reformulated shots would be treated as ‘biologically similar’ to
existing Covid-19 shots and be allowed to skip clinical trials
altogether.
Apparently the FDA
did not have the votes to just pass this as a policy question. If you
ask anyone whether reformulated mRNA represents a new molecular entity,
well of course it is, so that would require formal regulatory review.
What the FDA did instead was to smuggle the policy question in disguised as a vote about reformulated ‘boosters’ for the fall.
In essence, the FDA just started doing the Future
Framework (picking variants willy nilly, skipping clinical trials) and
essentially dared the committee members to turn down a booster dose —
knowing that all of the VRBPAC members are hand-picked because they’ve
never met a vaccine they did not like.
So of course only two people on the committee had the
courage to turn down a booster dose — even though it was based on this
preposterous process (that was never formally adopted) where there was
literally no data at all ... By stealth, the FDA replaced a system based
on evidence with a system based entirely on belief.”
Worst Idea in the History of Public Health
A decision to release reformulated mRNA shots without additional
clinical trials is the worst development yet, by far, and has the power
to radically change medical science moving forward.
Not only will completely untested COVID injections be churned out,
but this “framework” may also, over time, be widened to include other
vaccines and drugs that drug makers may want to tinker with. Heck, it
could even lower standards for drug trials in general, which
historically have required at least 10 years of multi-phase testing.8
In a May 31, 2022, Substack article, Rogers explained the origin and purpose of this incredibly dangerous proposal:9
“Pfizer and Moderna have a problem — their mRNA
COVID-19 shots do not stop infection, transmission, hospitalization, nor
death from the SARS-CoV-2 virus. Everyone knows this ... Pfizer and
Moderna are making about $50 billion a year on these shots and they want
that to continue.
So they need to reformulate the shots. Maybe target a
new variant, maybe change some of the ingredients — who knows, these
shots don’t work so it’s not clear what it will take to get them to
work. This is a problem because reformulated shots mean new clinical
trials and new regulatory review by the FDA.
There is a decent chance that any reformulated shot
might fail a new clinical trial and the public is deeply skeptical of
these shots so the scrutiny would be intense.
So Pfizer and Moderna have figured out a way to use
regulatory capture to get their reformulated COVID-19 shots approved
WITHOUT further clinical trials. Their scheme is called the ‘Future
Framework’ ... The purpose of the ‘Future Framework’ is to rig the
COVID-19 vaccine regulatory process in perpetuity in favor of the
pharmaceutical industry.
If this ‘Future Framework’ is approved all future
COVID-19 shots, regardless of the formulation, will automatically be
deemed ‘safe and effective’ without additional clinical trials because
they are considered ‘biologically similar’ to existing shots.
This is literally the worst idea in the history of
public health. If you change a single molecule of mRNA in these shots it
will change health outcomes in ways that no one can anticipate. That
necessarily requires new clinical trials — which is what the FDA is
proposing to skip ...
The FDA authorized COVID-19 shots for kids on June 14
and 15. So if the FDA approves the ‘Future Framework’ on June 28th, the
shots that will be given to kids (and Americans of all ages) in the
fall will be the reformulated shots that skipped clinical trials.”
SARS-CoV-2 Is a Horrible Vaccine Candidate, and They Know It
Before we continue, let’s review one important factor that tends to get lost. As explained by Rogers,10
“Viruses that evolve rapidly are bad candidates for a vaccine,” for the
simple reason that they mutate faster than vaccine development can keep
up with.
This is why we don’t have a vaccine against the common cold. It’s’
also why all previous attempts to develop a coronavirus vaccine failed.
Those studies never made it past animal trials. The vaccines caused
antibody-dependent enhancement, making the animals sicker than normal
when exposed to the virus.
Most people are unaware that SARS-CoV-2 mutates at a rate that is two to 10 times faster than the influenza virus,11,12
and these mutations can considerably reduce vaccine effectiveness.
Indeed, we’ve seen this both with the seasonal flu vaccine and the COVID
shots. When you vaccinate against a rapidly mutating virus you also run
the risk of pressuring it into a more virulent and/or vaccine-resistant
form. As noted by Rogers:
“The FDA’s ‘expert advisory committee’ (VRBPAC) met
on April 6, 2022 to discuss the ‘Future Framework’ for the first time.
All of the committee members agreed that COVID-19 shots are not working,
that boosting multiple times a year was not feasible, and that the
shots need to be reformulated.
They also unanimously agreed that there are no
‘correlates of protection’ that one can use to predict what antibody
levels would be sufficient to prevent SARS-CoV-2 infection.”
By now, the VRBPAC must know that the only way forward, really, is to
withdraw the COVID shots and focus on therapeutics. But they’re not
doing that. Instead, they’re doubling down on a failed strategy. On top
of that, they’re making the situation even worse by foregoing clinical
trials. There’s no doubt in my mind that this will pose grave risks to
public health. I agree with Rogers, who said:13
“Think about it. The more mRNA you put into a shot,
the higher the adverse event rate (as the genetically modified mRNA
hijacks the cell and starts cranking out spike proteins). So if Pfizer
and Moderna put more mRNA into these shots (in order to cover multiple
variants) adverse event rates will skyrocket.
But if Pfizer and Moderna put less mRNA per
variant into a shot (in order to keep the total amount of mRNA at 100
mcg for Moderna and 30 mcg for Pfizer) then the effectiveness against
any one particular variant will be reduced. The Future Framework is 100%
guaranteed to fail.”
They’re Fudging Effectiveness Too
The FDA also insists that, due to time constraints, evaluation of
effectiveness must rely on “measures other than actual health outcomes.”14 In other words, whether the shots actually lower your risk of severe illness, hospitalization and death will have no bearing.
The only measure that will be taken into account is whether or not
the jab triggers a rise in antibody levels, which has never been proven
to offer significant protection. This also means that as long as
antibody levels are through the roof, the death rate could be through
the roof too, and the jabs will still be used, because that’s not part
of the equation.
The focus on antibody levels to the exclusion of everything else may
actually be backfiring. Data from Moderna’s trial suggest the shot
actually makes you more prone to repeat infections due to the inhibition
of antibodies against a particular portion of the virus.
A preprint study15,16
posted on medRxiv April 19, 2022, found adult participants in Moderna’s
trial who got the real injection, and later got a breakthrough
infection, did not generate antibodies against the nucleocapsid — a key
component of the virus — as frequently as did those in the placebo arm.
Placebo recipients produced anti-nucleocapsid antibodies twice as
often as those who got the Moderna shot, and their anti-nucleocapsid
response was larger regardless of the viral load. As a result of their
inhibited antibody response, those who got the jab may be more prone to
repeated COVID infections.
These findings are further corroborated by data from the U.K. Health
Security Agency. It publishes weekly COVID-19 vaccine surveillance data,
including anti-nucleocapsid antibody levels. The report17,18
for Week 13, issued March 31, 2022, shows that COVID-jabbed individuals
with breakthrough infections indeed have lower levels of these
antibodies.
For clarity, antibodies thought to offer protection against COVID are
the antibodies against the spike protein and the receptor binding
domain (RBD).19
But this study suggests antibodies against other parts of the virus may
play an equally important role, and at least one of them is being
inhibited rather than boosted, resulting in a situation where you can
get reinfected time and again.
The moral of the story here is that there is a whole lot we do not
know about this virus, these shots, and the interaction between them.
So, allowing the vaccine makers to reformulate the shots without
clinical trials is a recipe for disaster.
Vaccine Trials Are Routinely Rigged
Over the years, we’ve seen plenty of examples of how vaccine trials
are being rigged, and what the FDA is now proposing is really just an
extreme expansion and formalization of that rigging. For example, in
2017, an eight-month investigation by Slate magazine20 revealed that HPV vaccine trials “weren’t designed to properly assess safety.”
In an internal report about Gardasil 9, obtained through a Freedom of
Information Act (FOIA) request, the European Medicines Agency (EMA) had
actually called attention to some of these problems, saying Merck’s
approach was “unconventional and suboptimal” and that it left
“uncertainty” about Gardasil’s safety. Yet nothing was done about it.
Then, in 2020, Dr. Peter Gøtzsche — a Danish physician-researcher,
professor and cofounder of the Cochrane Collaboration and the Nordic
Cochrane Centre — and two colleagues published a review and
meta-analysis21 of the data from 24 HPV vaccine trials. Slate magazine reported those findings as well.22
Again, the conclusion was that HPV trials had put safety on the back
burner by failing to conduct proper safety testing. Still, to quote
Slate magazine, “The findings don’t affect official recommendations to
get vaccinated.” According to Gøtzsche and his coauthors:23
“We judged all 24 studies to be at high risk of bias.
Serious harms were incompletely reported for 72% of participants
(68,610/95,670). Nearly all control participants received active
comparators (48,289/48,595, 99%). No clinical study report included
complete case report forms ...
At 4 years follow-up, the HPV vaccines decreased
HPV-related cancer precursors and treatment procedures but increased
serious nervous system disorders (exploratory analysis) and general
harms.
As the included trials were primarily designed to
assess benefits and were not adequately designed to assess harms, the
extent to which the HPV vaccines’ benefits outweigh their harms is
unclear.”
Not recording injuries, or recording them improperly (such as listing
an injury as a preexisting condition, for example), is a common tactic
used to fudge results and make a vaccine appear safer than it is.
Another common strategy is to exclude any parameter that turns out to be
problematic, and that includes participants who are injured.
Because this is such a common trick, the fact that 3,000 of the 4,526
children (aged 6 months through 4 years) enrolled in Pfizer’s pediatric
COVID trial were excluded is a huge red flag.24 Even more suspicious is the fact that Pfizer doesn’t explain why two-thirds of the children were dropped.
World Health Organization Is Behind Idea to Toss Safety
The FDA did not invent the “Future Framework” idea all by itself,
however. According to Rogers, the World Health Organization and other
predictable names are the real masterminds:25
“I did not understand until ... I started to write
this article, that this entire ‘Future Framework’ is actually coming
from the WHO. The Bill & Melinda Gates Foundation is the biggest
voluntary contributor to the WHO. So Gates is likely directing the play.
Gates requires that WHO use the McKinsey consulting
firm so this is probably a McKinsey operation (and McKinsey also works
for Pharma so this is a huge conflict of interest). As Naomi Wolf points
out, the involvement of the WHO also raises troubling questions about
the influence of the Chinese Communist Party over this process.
As far back as January, the WHO/Gates/McKinsey junta
realized that these shots were terrible and so they decided to use that
as an opportunity to seize even more power and control.
The WHO set up a Technical Advisory Group on COVID-19
Vaccine Composition (TAG-CO-VAC) to implement these Orwellian ‘Future
Frameworks’ across the developed world to lower manufacturing costs for
Pharma and avoid bothersome health data that might hurt profits. All the
messaging we have seen from the FDA and leaked to the press was
initially developed and released by TAG-CO-VAC.”
We Must Reject All Future mRNA Shots
This COVID debacle — from its fraudulent PCR test beginnings, to
these devastatingly dangerous COVID shots and the intentional negligence
by vaccine makers and health authorities — is the most shocking example
of a criminal enterprise I’ve ever seen. Nothing else even comes close.
And the proverbial cherry on top that proves none of it is accidental
or caused by ignorance is this sneaky and underhanded erasure of the
requirement of clinical trials for all future COVID shots in the name of
expedience. COVID-19 is not a death sentence — far from it. So, there’s
no need for expedience. And since there’s no need for expedience,
there’s also no need to accept collateral damage in the form of COVID
jab-related injuries and deaths.
So, why are they doing this? That’s the million-dollar question, and
the most obvious answers are all disturbing in the extreme. At best,
they don’t care how many people, including children, suffer and die. At
worst, the intention is to dramatically reduce the population through
adverse effects on fertility, reduction of life span and near-term
death.
To save ourselves, indeed, to save mankind, we must reject all mRNA
shots, present and future. And not just the COVID shots but also any
others that are in the pipeline, because if they’re willing to skip the
most basic of safety protocols once, you can be sure they’ll do it
again.
Skimping on safety assessment has been the secret norm for decades,
and now they’re attempting to formalize that process using stealth and
subversion. The initial COVID shots haven’t even completed their trials
yet, and they want you to believe those incomplete trials are sufficient
to “prove” all future reformulations are “safe and effective” too!
We’ve also seen how the U.S. Centers for Disease Control and
Prevention came out saying they’ve seen no safety signals in the data,
only to later discover that the reason they didn’t find any was because
they never actually looked.26
It’s nothing short of insanity, and over the past two years,
government agencies have proven they are not going to put a stop to the
madness. No, they’re going to take this experiment as far as it’ll go,
and that means, until people everywhere say “No more,” and leave all
their stockpiles to rot.
There’s Help if You’ve Taken the Jab
In closing, if you’ve already taken one or more COVID jabs and now
regret it, first, the most important step you can take is to not take
any more shots, and that includes conventional vaccines and any other
mRNA or gene-based injections as well.
Next, if you suspect your health may have been impacted, check out
the Frontline COVID-19 Critical Care Alliance’s (FLCCC) post-vaccine
treatment protocol, I-RECOVER,27 which you can download from covid19criticalcare.com in several different languages.