In a reasonably stunning flip of occasions, the U.S. Meals and Drug Administration sneaked in a “Future Framework”1 scheme that can permit Pfizer and Moderna to reformulate and launch up to date COVID photographs with out conducting any further human medical trials, apart from what’s already been performed.2,3,4
FDA Rewrites the Guidelines on the Fly
A vote on the Framework was scheduled to be taken June 28, 2022, by the FDA’s Vaccines and Associated Organic Merchandise Advisory Committee (VRBPAC), however whereas the VRBPAC permitted (19-2) a bivalent COVID shot for fall 2022,5 the anticipated voting on the Framework, particularly, didn’t appear to happen — solely it DID.
Because it seems, we’ve been bamboozled but once more by an company that retains rewriting the foundations on the fly. Toby Rogers, Ph.D. — a political economist whose analysis focus is on regulatory seize and Large Pharma corruption6 — explains how they sneaked this one by us:7
“Yesterday [June 28], the FDA’s Vaccines and Associated Organic Merchandise Advisory Committee permitted a bivalent COVID-19 shot with the Wuhan pressure and the Omicron variant …
On the assembly, the producers (Moderna, Pfizer, and Novavax) had been requested what their manufacturing timelines are… and so they mentioned out loud, ‘As long as we don’t have to offer any medical information, we’ll have them prepared by fall.’ Nobody had an issue with that …
Wait, maintain up, I assumed the FDA was voting on the Future Framework yesterday? The coverage query was whether or not reformulated COVID-19 photographs can be handled as new molecular entities (which they’re) by which case they need to be topic to formal assessment or whether or not reformulated photographs can be handled as ‘biologically comparable’ to current Covid-19 photographs and be allowed to skip medical trials altogether.
Apparently the FDA didn’t have the votes to simply move this as a coverage query. If you happen to ask anybody whether or not reformulated mRNA represents a brand new molecular entity, nicely in fact it’s, so that will require formal regulatory assessment.
What the FDA did as an alternative was to smuggle the coverage query in disguised as a vote about reformulated ‘boosters’ for the autumn.
In essence, the FDA simply began doing the Future Framework (selecting variants willy nilly, skipping medical trials) and basically dared the committee members to show down a booster dose — figuring out that the entire VRBPAC members are hand-picked as a result of they’ve by no means met a vaccine they didn’t like.
So in fact solely two individuals on the committee had the braveness to show down a booster dose — though it was based mostly on this preposterous course of (that was by no means formally adopted) the place there was actually no information in any respect … By stealth, the FDA changed a system based mostly on proof with a system based mostly completely on perception.”
Worst Concept within the Historical past of Public Well being
A choice to launch reformulated mRNA photographs with out further medical trials is the worst growth but, by far, and has the ability to seriously change medical science shifting ahead.
Not solely will fully untested COVID injections be churned out, however this “framework” may, over time, be widened to incorporate different vaccines and medicines that drug makers might need to tinker with. Heck, it might even decrease requirements for drug trials usually, which traditionally have required not less than 10 years of multi-phase testing.8
In a Could 31, 2022, Substack article, Rogers defined the origin and objective of this extremely harmful proposal:9
“Pfizer and Moderna have an issue — their mRNA COVID-19 photographs don’t cease an infection, transmission, hospitalization, nor demise from the SARS-CoV-2 virus. Everybody is aware of this … Pfizer and Moderna are making about $50 billion a yr on these photographs and so they need that to proceed.
So they should reformulate the photographs. Possibly goal a brand new variant, possibly change among the components — who is aware of, these photographs don’t work so it’s not clear what it is going to take to get them to work. It is a drawback as a result of reformulated photographs imply new medical trials and new regulatory assessment by the FDA.
There’s a respectable likelihood that any reformulated shot may fail a brand new medical trial and the general public is deeply skeptical of those photographs so the scrutiny can be intense.
So Pfizer and Moderna have discovered a manner to make use of regulatory seize to get their reformulated COVID-19 photographs permitted WITHOUT additional medical trials. Their scheme is named the ‘Future Framework’ … The aim of the ‘Future Framework’ is to rig the COVID-19 vaccine regulatory course of in perpetuity in favor of the pharmaceutical trade.
If this ‘Future Framework’ is permitted all future COVID-19 photographs, whatever the formulation, will mechanically be deemed ‘protected and efficient’ with out further medical trials as a result of they’re thought-about ‘biologically comparable’ to current photographs.
That is actually the worst thought within the historical past of public well being. If you happen to change a single molecule of mRNA in these photographs it is going to change well being outcomes in ways in which nobody can anticipate. That essentially requires new medical trials — which is what the FDA is proposing to skip …
The FDA licensed COVID-19 photographs for teenagers on June 14 and 15. So if the FDA approves the ‘Future Framework’ on June twenty eighth, the photographs that will probably be given to children (and People of all ages) within the fall would be the reformulated photographs that skipped medical trials.”
SARS-CoV-2 Is a Horrible Vaccine Candidate, and They Know It
Earlier than we proceed, let’s assessment one necessary issue that tends to get misplaced. As defined by Rogers,10 “Viruses that evolve quickly are unhealthy candidates for a vaccine,” for the straightforward cause that they mutate sooner than vaccine growth can sustain with.
That is why we don’t have a vaccine towards the widespread chilly. It’s’ additionally why all earlier makes an attempt to develop a coronavirus vaccine failed. These research by no means made it previous animal trials. The vaccines precipitated antibody-dependent enhancement, making the animals sicker than regular when uncovered to the virus.
Most individuals are unaware that SARS-CoV-2 mutates at a charge that’s two to 10 instances sooner than the influenza virus,11,12 and these mutations can significantly scale back vaccine effectiveness. Certainly, we’ve seen this each with the seasonal flu vaccine and the COVID photographs. Whenever you vaccinate towards a quickly mutating virus you additionally run the danger of pressuring it right into a extra virulent and/or vaccine-resistant kind. As famous by Rogers:
“The FDA’s ‘knowledgeable advisory committee’ (VRBPAC) met on April 6, 2022 to debate the ‘Future Framework’ for the primary time. The entire committee members agreed that COVID-19 photographs aren’t working, that boosting a number of instances a yr was not possible, and that the photographs have to be reformulated.
In addition they unanimously agreed that there are not any ‘correlates of safety’ that one can use to foretell what antibody ranges can be adequate to forestall SARS-CoV-2 an infection.”
By now, the VRBPAC should know that the one manner ahead, actually, is to withdraw the COVID photographs and give attention to therapeutics. However they’re not doing that. As a substitute, they’re doubling down on a failed technique. On high of that, they’re making the state of affairs even worse by foregoing medical trials. There’s little doubt in my thoughts that this can pose grave dangers to public well being. I agree with Rogers, who mentioned:13
“Give it some thought. The extra mRNA you place right into a shot, the upper the hostile occasion charge (because the genetically modified mRNA hijacks the cell and begins cranking out spike proteins). So if Pfizer and Moderna put extra mRNA into these photographs (to be able to cowl a number of variants) hostile occasion charges will skyrocket.
But when Pfizer and Moderna put much less mRNA per variant right into a shot (to be able to maintain the full quantity of mRNA at 100 mcg for Moderna and 30 mcg for Pfizer) then the effectiveness towards anyone explicit variant will probably be lowered. The Future Framework is 100% assured to fail.”
They’re Fudging Effectiveness Too
The FDA additionally insists that, as a result of time constraints, analysis of effectiveness should depend on “measures apart from precise well being outcomes.”14 In different phrases, whether or not the photographs truly decrease your danger of extreme sickness, hospitalization and demise could have no bearing.
The one measure that will probably be taken into consideration is whether or not or not the jab triggers an increase in antibody ranges, which has by no means been confirmed to supply important safety. This additionally signifies that so long as antibody ranges are by means of the roof, the demise charge might be by means of the roof too, and the jabs will nonetheless be used, as a result of that’s not a part of the equation.
The give attention to antibody ranges to the exclusion of every part else may very well be backfiring. Information from Moderna’s trial counsel the shot truly makes you extra susceptible to repeat infections because of the inhibition of antibodies towards a specific portion of the virus.
A preprint examine15,16 posted on medRxiv April 19, 2022, discovered grownup contributors in Moderna’s trial who obtained the true injection, and later obtained a breakthrough an infection, didn’t generate antibodies towards the nucleocapsid — a key part of the virus — as continuously as did these within the placebo arm.
Placebo recipients produced anti-nucleocapsid antibodies twice as typically as those that obtained the Moderna shot, and their anti-nucleocapsid response was bigger whatever the viral load. Because of their inhibited antibody response, those that obtained the jab could also be extra susceptible to repeated COVID infections.
These findings are additional corroborated by information from the U.Ok. Well being Safety Company. It publishes weekly COVID-19 vaccine surveillance information, together with anti-nucleocapsid antibody ranges. The report17,18 for Week 13, issued March 31, 2022, exhibits that COVID-jabbed people with breakthrough infections certainly have decrease ranges of those antibodies.
For readability, antibodies thought to supply safety towards COVID are the antibodies towards the spike protein and the receptor binding area (RBD).19 However this examine suggests antibodies towards different components of the virus might play an equally necessary function, and not less than certainly one of them is being inhibited reasonably than boosted, leading to a state of affairs the place you may get reinfected again and again.
The ethical of the story right here is that there’s a complete lot we have no idea about this virus, these photographs, and the interplay between them. So, permitting the vaccine makers to reformulate the photographs with out medical trials is a recipe for catastrophe.
Vaccine Trials Are Routinely Rigged
Through the years, we’ve seen loads of examples of how vaccine trials are being rigged, and what the FDA is now proposing is de facto simply an excessive growth and formalization of that rigging. For instance, in 2017, an eight-month investigation by Slate journal20 revealed that HPV vaccine trials “weren’t designed to correctly assess security.”
In an inside report about Gardasil 9, obtained by means of a Freedom of Data Act (FOIA) request, the European Medicines Company (EMA) had truly known as consideration to a few of these issues, saying Merck’s method was “unconventional and suboptimal” and that it left “uncertainty” about Gardasil’s security. But nothing was performed 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 revealed a assessment and meta-analysis21 of the information from 24 HPV vaccine trials. Slate journal reported these findings as nicely.22
Once more, the conclusion was that HPV trials had put security on the again burner by failing to conduct correct security testing. Nonetheless, to cite Slate journal, “The findings don’t have an effect on official suggestions to get vaccinated.” In response to Gøtzsche and his coauthors:23
“We judged all 24 research to be at excessive danger of bias. Severe harms had been incompletely reported for 72% of contributors (68,610/95,670). Almost all management contributors acquired lively comparators (48,289/48,595, 99%). No medical examine report included full case report types …
At 4 years follow-up, the HPV vaccines decreased HPV-related most cancers precursors and therapy procedures however elevated severe nervous system problems (exploratory evaluation) and common harms.
Because the included trials had been primarily designed to evaluate advantages and weren’t adequately designed to evaluate harms, the extent to which the HPV vaccines’ advantages outweigh their harms is unclear.”
Not recording accidents, or recording them improperly (corresponding to itemizing an harm as a preexisting situation, for instance), is a typical tactic used to fudge outcomes and make a vaccine seem safer than it’s. One other widespread technique is to exclude any parameter that seems to be problematic, and that features contributors who’re injured.
As a result of that is such a typical trick, the truth that 3,000 of the 4,526 kids (aged 6 months by means of 4 years) enrolled in Pfizer’s pediatric COVID trial had been excluded is a big crimson flag.24 Much more suspicious is the truth that Pfizer doesn’t clarify why two-thirds of the youngsters had been dropped.
World Well being Group Is Behind Concept to Toss Security
The FDA didn’t invent the “Future Framework” thought all by itself, nonetheless. In response to Rogers, the World Well being Group and different predictable names are the true masterminds:25
“I didn’t perceive till … I began to write down this text, that this whole ‘Future Framework’ is definitely coming from the WHO. The Invoice & Melinda Gates Basis is the most important voluntary contributor to the WHO. So Gates is probably going directing the play.
Gates requires that WHO use the McKinsey consulting agency so that is in all probability a McKinsey operation (and McKinsey additionally works for Pharma so this can be a large battle of curiosity). As Naomi Wolf factors out, the involvement of the WHO additionally raises troubling questions in regards to the affect of the Chinese language Communist Get together over this course of.
Way back to January, the WHO/Gates/McKinsey junta realized that these photographs had been horrible and they also determined to make use of that as a possibility to grab much more energy and management.
The WHO arrange a Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) to implement these Orwellian ‘Future Frameworks’ throughout the developed world to decrease manufacturing prices for Pharma and keep away from bothersome well being information that may damage earnings. All of the messaging we have now seen from the FDA and leaked to the press was initially developed and launched by TAG-CO-VAC.”
We Should Reject All Future mRNA Photographs
This COVID debacle — from its fraudulent PCR check beginnings, to those devastatingly harmful COVID photographs and the intentional negligence by vaccine makers and well being authorities — is essentially the most stunning instance of a prison enterprise I’ve ever seen. Nothing else even comes shut.
And the proverbial cherry on high that proves none of it’s unintentional or attributable to ignorance is that this sneaky and underhanded erasure of the requirement of medical trials for all future COVID photographs within the title of expedience. COVID-19 is just not a demise sentence — removed from it. So, there’s no want for expedience. And since there’s no want for expedience, there’s additionally no want to just accept collateral harm within the type of COVID jab-related accidents and deaths.
So, why are they doing this? That’s the million-dollar query, and the obvious solutions are all disturbing within the excessive. At greatest, they don’t care how many individuals, together with kids, endure and die. At worst, the intention is to dramatically scale back the inhabitants by means of hostile results on fertility, discount of life span and near-term demise.
To avoid wasting ourselves, certainly, to save lots of mankind, we should reject all mRNA photographs, current and future. And never simply the COVID photographs but in addition any others which can be within the pipeline, as a result of in the event that they’re keen to skip essentially the most fundamental of security protocols as soon as, you may be positive they’ll do it once more.
Skimping on security evaluation has been the key norm for many years, and now they’re trying to formalize that course of utilizing stealth and subversion. The preliminary COVID photographs haven’t even accomplished their trials but, and so they need you to consider these incomplete trials are adequate to “show” all future reformulations are “protected and efficient” too!
We’ve additionally seen how the U.S. Facilities for Illness Management and Prevention got here out saying they’ve seen no security alerts within the information, solely to later uncover that the explanation they didn’t discover any was as a result of they by no means truly regarded.26
It’s nothing wanting madness, and over the previous two years, authorities companies have confirmed they aren’t going to place a cease to the insanity. No, they’re going to take this experiment so far as it’ll go, and meaning, till individuals in all places say “No extra,” and depart all their stockpiles to rot.
There’s Assist if You’ve Taken the Jab
In closing, when you’ve already taken a number of COVID jabs and now remorse it, first, an important step you may take is to not take any extra photographs, and that features standard vaccines and every other mRNA or gene-based injections as nicely.
Subsequent, when you suspect your well being might have been impacted, try the Frontline COVID-19 Crucial Care Alliance’s (FLCCC) post-vaccine therapy protocol, I-RECOVER,27 which you’ll be able to download from covid19criticalcare.com in a number of totally different languages.
