I WISH THEY WOULD TAKE A BREAK š°
What is the āFuture Frameworkā? Iām late in discovering this new awfulness they cooked up, may G-d save us.
It says in Psalms that our enemies will praise G-d when our salvation comes. Why? Because only they know the full extent of the evil they have planned for us.
So, when G-d foils their plans, only they can fully appreciate the miracles that G-d did to bring our salvation.
Thatās what I feel like now. Every week the wicked have another plot! Surely there are more that we donāt even know.
(I wish we could send the whole lot of them off on a nice vacation somewhere so we could get some peace..)
Seriously, we must be in the ātransitionā stage of ālaborā right now before the redemption, because this is so intense.
G-d must really want our repentance and prayer now.
Here is a little glimpse at what is so horribly wrong with the current covid shots.
Could it get worse, G-d forbid? Yes.
Here is the latest threat. I am copying this information from two substack articles by Toby Rogers. His original articles are linked at the end.
Article #1:
The FDA's proposed "Future Framework" is the worst idea in the history of public health
If approved on June 28, all reformulated Covid-19 shots will skip clinical trials
I. Pfizer and Modernaās Dilemma
Pfizer and Moderna have a problem ā their mRNA Covid-19 shots do not stop infection, transmission, hospitalization, nor death from the SARS-CoV-2 virus. Everyone knows this. Over half a billion doses of this product have been injected into Americans in the past 17 months and these shots have made no discernible impact on the course of the pandemic. Far more Americans have died of coronavirus since the introduction of the shots than before they were introduced.
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 ā who knows, these shots donāt work so itās 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 āFuture Frameworkā and it will be voted on by the FDAās Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28.
II. Doubling down on a failed strategy
Viruses vary by region. At any given time, the influenza strain circulating in England is different than it is in Thailand, the U.S., or South Africa. However, pharmaceutical companies prefer to create one-size-fits-all vaccines in order to decrease manufacturing costs and thereby increase profits. So the W.H.O. and public health agencies around the world (including FDA and CDC) have created a vast āinfluenza surveillance networkā that identifies the different influenza strains in circulation. Then they engage in an elaborate theatrical performance called the āflu strain selection processā where they select four influenza strains that will go into the flu vaccine that year (there is one flu shot for all countries in the northern hemisphere and one flu shot for all countries in the southern hemisphere, thatās it).
This carefully choreographed process results in failure more often than not. This is not a surprise ā using a one-vaccine-fits-all approach to prevent a rapidly evolving virus that varies by region is unlikely to work. Lisa Grohskopf from the CDCās Influenza Division reports that last year the flu shot was somewhere between 8% and 14% effective (based on data from seven sites that participate in the U.S. Flu Vaccine Effectiveness Network).
But a case study of a flu outbreak at the University of Michigan between October and November 2021 found that the effectiveness of the flu vaccine was literally zero.
Over the last thirty years, the federal government has paid out more compensation for adverse events in connection with the flu shot than any other vaccine ā so we know that the shot comes with a high rate of harms. Given that the flu shot does not stop the overwhelming majority of flu cases, the harms likely outweigh any benefits.
In a sane world, the WHO, FDA, and CDC would admit that they made a strategic mistake and then change course to find better ways to support the human immune system. But we donāt live in a sane world. Instead, the FDA is proposing to take the failed flu strain selection process and apply it to future Covid-19 shots.
III. The FDA knew that Covid-19 shots would fail but they proceeded anyway
There are a quadrillion x quadrillion viruses in the world (literally more viruses on earth than stars in the known universe). Only a couple hundred of those seem to have the potential to impact human health. But some viruses make better candidates for a vaccine than others. Viruses that have been around a long time, that are very stable and evolve slowly are the best candidates for a vaccine.
Viruses that evolve rapidly are bad candidates for a vaccine. There is no vaccine for the common cold nor HIV because these viruses evolve too quickly. The SARS-CoV-2 virus is a bad candidate for a vaccine which is why all previous attempts to develop a vaccine against coronaviruses have failed (they never made it out of animal trials because the animals died during challenge trials or were injured by the vaccine).
What are some of the bad things that can happen when you vaccinate against a rapidly evolving virus? Original antigenic sin, antibodyĀ dependent enhancement, and the possibility of accelerating the evolution of the virus in ways that make it more virulent(and even more resistant to vaccination).
Trevor Bedford has his own lab at the Fred Hutchinson Cancer Center where he researches the evolution of Covid-19. He gave a fascinating presentation at the April 6 meeting of the FDAās Vaccines and Related Biological Products Advisory Committee meeting where he explained that SARS-CoV-2 is evolving rapidly. He explained that SARS-CoV-2 evolves twice to ten times as fast as the flu virus and these mutations āsubstantiallyā reduce vaccine effectiveness. Following the introduction of Covid-19 vaccines, the evolution of the virus has accelerated.
Dr. Bedfordās presentation rattled some of the smarter members of the VRBPAC because his data scream ā āSARS-CoV-2 is a bad candidate for a vaccine!ā But FDA officials just mumbled some platitudes and then continued on with the meeting.
The only way out of the pandemic is to withdraw these vaccines from the market and pivot to therapeutics. Instead, the FDA is proposing to just hide the data from the American people.
IV. The āFuture Frameworkā = no more clinical trials for Covid-19 shots ever again
The purpose of the āFuture Frameworkā is to rig the Covid-19 vaccine regulatory process in perpetuity in favor of the pharmaceutical industry. If this āFuture Frameworkā is approved all future Covid-19 shots, regardless of the formulation, will automatically be deemed āsafe and effectiveā without additional clinical trials because they are considered ābiologically similarā 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 ā which is what the FDA is proposing to skip.
The FDAās āexpert advisory committeeā (VRBPAC) met on April 6, 2022 to discuss the āFuture Frameworkā 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 ācorrelates of protectionā that one can use to predict what antibody levels would be sufficient to prevent SARS-CoV-2 infection.
On June 28 the VRBPAC will meet once again to discuss the āFuture Frameworkā and it will be presented as a done deal because manufacturers want a decision on vaccine strain selection by June in order to deliver shots for autumn vaccination appointments.
The FDA authorized Covid-19 shots for kids on June 14 and 15. So if the FDA approves the āFuture Frameworkā 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.
V. Monovalent Covid-19 shots failed, so maybe throwing two, three, or four variants into a single shot will make it better?
When it comes to the flu shot, the FDA tries to hedge their bets by putting four strains of the virus into a single shot (so called āquadrivalentā vaccines). As I explained above, this strategy does not work. But these people are not very clever so thatās exactly what they are planning to do with future Covid-19 shots.
Moderna is already signaling that they intend to manufacture a Covid-19 shot with the Alpha variant and then, to make it ānew and improved (TM)ā, they will add genetically modified mRNA targeting the Beta variant. Hereās the best part ā Moderna claims that this formulation (Alpha + Beta) will somehow protect against Omicron variants ā even though by the time these reformulated shots get to market, none of these variants will likely still be in widespread circulation.
There are reasons to believe that this approach will make future Covid-19 shots even less effective and more dangerous than the current failed Covid-19 shots.
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. If the āFuture Frameworkā is approved, effectiveness of these shots will decrease, adverse events will increase, these shots will fuel the evolution of variants that evade the vaccines, and there will be no clinical trial data before these reformulated Covid-19 shots are unleashed on the unsuspecting public.
VI. Summary
The FDAās Vaccines and Related Biological Products Advisory Committee will meet on June 28 to vote on a āFuture Frameworkā for evaluating so-called ānext generationā Covid-19 shots. TheĀ āFuture Frameworkā is a plan to rig the Covid-19 vaccine regulatory process in perpetuity.
The āFuture Frameworkā would take the āflu strain selection processā that fails every year and apply it to future (reformulated) Covid-19 shots. Federal bureaucrats, many of whom have financial conflicts of interests, would choose which SARS-CoV-2 variants to include in a yearly (or twice yearly) Covid-19 shot. In the process, all future Covid-19 shots will be deemed automatically āsafe and effectiveā without further clinical trials because they are considered ābiologically similarā to existing Covid-19 shots.
The āFuture Frameworkā is the most reckless idea in the history of public health. It shows that the FDA has completely abandoned science and its statutory duty to protect the public. If the Republic is to survive, we must stop the āFuture Frameworkā before June 28.
(The article concluded with a call to action and contact information for elected officials, which is at the end of the second article.)
Article #2:
Weird that the "I-Believe-The-Science(TM)" crowd has completely given up on science
The NY Times announces that henceforth, clinical trials for Covid-19 shots must be abandoned because real world data makes the cartel look bad
I. Pharma is losing the game so they are throwing the chess board across the room
The NY Times published a vile piece of fascist Pharma propaganda today. Berenson flaggedthe online version of the article yesterday. As you know, I have been yelling about the FDAās Orwellian āFuture Frameworkā for weeks because itās literally the worst idea in the history of public health.
It turns out that itās even worse than I thought.
Pharma has already begun a PR offensive to get it across the line and Sharon LaFraniere of the NY Times was eager to do their bidding.
Hereās whatās happening. The mRNA shots are not working against SARS-CoV-2. Everyone knows this. So Moderna and Pfizer are racing to reformulate these shots. The reformulated shots are not working either.Just last week Moderna was touting a bivalent shot that combined Alpha + Beta, but now, apparently, theyāve abandoned that approach. The NY Times article hypes a Moderna shot targeting earlier Omicron variants (it does not say, but perhaps BA.2 and BA.2.12.1?). However evidence from South Africa shows that BA.4 and BA.5 are outcompeting the earlier Omicron variants and the reformulated Moderna shot probably wonāt work against the new strains (the virus evolved for a reason ā to evade vaccines).
So what are predatory pharmaceutical companies and their feckless government enablers supposed to do!? Abandon clinical trials altogether!
Hereās how the NY Times describes this scheme:
ā¦many experts worry that the virus is evolving so quickly that it is outpacing the ability to modify vaccines, at least as long as the United States relies on human clinical trials for results.
See, itās not that coronavirus vaccine have failed over and over again (even though they have). Itās that This Wily Virus(TM) is just evolving so quickly that we could not possibly allow human clinical trials of coronavirus vaccines ever again. The only way to beat This Wily Virus(TM) at this point is to abandon science.
Of course it gets worse. The NY Timeselaborates:
The problem is that Moderna and Pfizer ā the maker of the other main coronavirus vaccine in the United States ā do not have enough time now to run more human clinical trials and still manufacture shots before the fall, when the Biden administration is hoping to be able to offer an updated vaccine to counter what public health experts predict will be a winter surge.
See, itās not that rapacious pharmaceutical companies want to suck all wealth out of the world and put it into their own pockets while setting up a 1,000 year Pharma Reich. No, no, no, silly. Itās just that they ādo not have enough timeā to do actual science anymore so they are just going to skip all that. Donāt you worry your little head about it.
Furthermore, only a conspiracy theorist would believe that the FDA has abandoned all of its statutory responsibilities to protect public health in order to prostitute themselves to Pharma. The Correct Understanding(TM) is that the FDA is being forced by circumstances outside their control to abandon science. This is not a problem because the cartel is truth, the cartel has always been truth, and since the cartel has decided to abandon science altogether then thatās the new science.
Henceforth, quite literally, the peasants will be forced every six months to inject whatever they are told, with no questions asked, and āthey will be [required by law to be] happy about itā.
Instead of human clinical trials the FDA will rely on a few test tube and mouse studies. In the article, Fauci describes this as, āalternative pathways of decision.ā That guy just oozes totalitarianism at this point.
So if the āFuture Frameworkā is approved on June 28 the new rules will be: a pharmaceutical company can claim that some new injection creates antibodies in a test tube or mouse (that no one else can see or audit). Done! Ship it and inject it! Thatās it. Even though the FDA admits that there are no ācorrelates of protection.ā
In the replies to my earlier articles about the Future Framework some astute readers have pointed out that the FDA has already abandoned human trials when it comes to Covid-19 shots in kids. None of the Moderna or Pfizer clinical trials in kids showed any real world health benefit at all. So they switched to looking at antibodies in the blood and use this tortured mental gymnastics called āimmunobridgingā to conjure up hypothetical future benefits that never materialize in the real world. Abandoning even the pretense of human trials and moving to test tubes and mice is the obvious next step in this complete abandonment of science.
When people say āI Believe The Science(TM)ā what they really mean is āI Support The Genocide.ā Thatās whatās happening. The FDA has not done science in two years, probably much longer than that.
There is no left and right in politics anymore. Just, the FDA Pharma Fascist Party where members are expected to participate in self-genocide for āthe good of societyā (read: the profits of the cartel)
vs.
the Rebel Alliance where we practice actual science, critical thinking, logic, and reason, and work every day to protect human health and dignity.
Any politician who wants the 18 million votes of single-issue medical freedom voters in November needs to know that there must be hearings, arrests, and trials of the bureaucrats at FDA, CDC, NIAID, HHS, and NIH who did this to us.
II. What is to be done?
In the meantime, here are the email addresses for all of the public health political appointees, FDA staff, and VRBPAC members who have a say in connection with the āFuture Frameworkā. Please contact them to urge them to reject this nonsense (proposed subject line and email text below ā or share your own personal story).
Subject line: The āFuture Frameworkā is the WORST idea in the history of public health. Please vote NO.
1. No Covid-19 shots for kids that failed clinical trials. According to the journal Nature Medicine, children and young people have a 99.995% recovery rate. According to the CDC, the overwhelming majority of children already have natural immunity. The harms from Covid-19 shots in kids are catastrophic.
2. The FDA and CDC must pivot to therapeutics. About twenty off-the-shelf treatments are more effective than vaccines (if used for prophylaxis or early intervention). Get these safe and effective medicines to people who need them and let doctors be doctors again and treat patients based on their own best clinical judgment.
3. Any reformulated Covid-19 shots MUST go through proper HUMAN clinical trials and FDA review. That means:
ā¢ large (50,000+ person) double-blind randomized controlled trials with inert saline placebos conducted by an independent third party;
ā¢ safety and efficacy studies for two years prior to any application; monitor the treatment and control group for the rest of their lives to record non-specific effects;
ā¢ must provide sterilizing immunity with greater than 90% efficacy and less than 0.1% Grade 3 Adverse Events; and
ā¢ proper monitoring for carcinogenesis, mutagenesis, and impairment of fertility.
[Contact list:]
sean.mccluskie@hhs.gov, commissioner@fda.hhs.gov, DeanofPublicHealth@brown.edu, Aux7@cdc.gov, Peter.Marks@fda.hhs.gov, Hong.Yang@fda.hhs.gov, Richard.Forshee@fda.hhs.gov, Huilee.Wong@fda.hhs.gov, Leslie.Ball@fda.hhs.gov, Doran.Fink@fda.hhs.gov, CBERVRBPAC@fda.hhs.gov, hanae@bcm.edu, paula.annunziato@merck.com, adam.berger@nih.gov, hbernstein@northwell.edu, acohn@cdc.gov, anc0@cdc.gov, hjanes@fredhutch.org, hgans@stanford.edu, david.kim@hhs.gov, asmonto@umich.edu, offit@chop.edu, spergam@fredhutch.org, Jportnoy@cmh.edu, erubin@hsph.harvard.edu, erubin@nejm.org, ashane@emory.edu, swamy002@mc.duke.edu, fullerao@umich.edu, bgellin@rockfound.org, RandyHawkins@cdrewu.edu, officeofthepresident@mmc.edu, JYLee@uams.edu, ofer.levy@childrens.harvard.edu, wayne_marasco@dfci.harvard.edu, cmeissner@tuftsmedicalcenter.org, mrn8d@virginia.edu, stanley-perlman@uiowa.edu, reingold@berkeley.edu, mhsawyer@ucsd.edu, mew2@cdc.gov
III. The FDA has opened the formal comment portal for the āFuture Frameworkā
If you prefer the official route, you can lodge a formal comment with the FDA by following the instructions (here). Enter docket number FDA-2022-N-0905 at
https://www.regulations.gov
by June 22 to tell the FDA what you think of their proposed plan to abandon clinical trials for Covid-19 shots in perpetuity.
ā¢ā¢ā¢(End of copied articles.)
Toby concludes with blessings and prayers for those who are fighting to save lives.
TRULY, G-d is the ONLY ONE WHO CAN HELP US. All our ātryingā is just because thatās what weāre also obligated to do, but worldwide repentance and prayer are what is most needed. We need to return to G-dās plan for a sane, humane world- His 7 laws for humanity, whose observance would preclude the horror we are now witnessing. See AskNoah.org.
Here are the links to Toby Rogers above 2 articles, AND to James Roguskiās excellent call to action:
