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Editor’s note: The U.S. Food and Drug Administration (FDA) tomorrow, June 28, will vote on the “Future Framework,” a scheme that would allow Pfizer and Moderna to “reformulate” COVID-19 mRNA vaccines in perpetuity, without conducting clinical trials on the new vaccines. Click here to tell the FDA to vote no on the “Future Framework.”
Introduction: The FDA always rigs the game on behalf of Pharma
Late Friday afternoon, the FDA released its agenda for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting that will vote on the Orwellian “Future Framework” on Tuesday, June 28.
Then on Saturday morning, the FDA released a briefing document in connection with this scheme to end science as we know it in connection with future COVID-19 shots. (Much appreciation to the brilliant James Roguski for alerting me to these documents.)
In this article, I will explain what is in the briefing document, what is likely to happen at the meeting and what can be done about it.
The FDA’s ‘Future Framework’ briefing document
The briefing document is 18 pages of text, 1.5 line spacing, with just 19 references — 9 of which are pre-prints or from the CDC’s in-house newsletter Morbidity and Mortality Weekly Report (MMWR) which means they are not peer-reviewed.
Any true believer in The Narrative(TM) could have written this in a few hours. To base the entire future of COVID-19 shots on this glorified undergrad term paper is madness.
As I predicted, even though the April 6 meeting was presented as an exploratory initial conversation that reached no conclusions whatsoever, the “Future Framework” is now being presented by the FDA as a done deal, fait accompli, you’d have to be crazy to insist on proper safety studies.
The core argument of the briefing document is hilarious (or rather, it would be hilarious if it was not a plan to permanently institutionalize genocide and hide the evidence). In several places the FDA argues (colloquialisms mine):
1. These COVID-19 shots work great, miracles really, incredibly effective, boy howdy do they work well! Boosters too, total home run, the Israelis even have 10-weeks of data showing that they might help old people. What more evidence could you want?
2. Okay, well, it depends on what you mean by “work.” These shots do not stop infection, transmission, hospitalization, or death, even though that’s why we licensed them. Any protection wears off fairly quickly, but It’s Not Our Fault(TM) because This Wily Virus(TM) mutates too fast and no one told us that it would ever mutate.
The briefing document literally states:
“The evaluation of modified vaccines for the purpose of vaccine strain composition decisions will need to rely mainly on comparative immunogenicity data due to the time constraints involved in vaccine manufacturing and clinical efficacy evaluation.”
Did you catch that? The evaluation “will need to rely on” (no decision to be made here) measures other than actual health outcomes because of “time constraints.”
Moderna, Pfizer and Novavax are all developing reformulated COVID-19 shots. But they know that the FDA is not going to look at health outcomes so they are going to great lengths to jack up the antibody response.
Pfizer tested a double-strength dose (60 mcg of mRNA instead of 30 mcg) even though they had previously ruled out a higher dose because of safety concerns. So the antibody levels are through the roof.
But the VRBPAC admitted on April 6 that there are no known correlates of protection (meaning: antibody levels do not tell you who will be immune) so these antibody measures are medically meaningless.
Sane people realize that if you turbo charge the immune response, you may also turbo charge adverse events. But the “Future Framework” allows pharmaceutical companies to skip clinical trials altogether.
Furthermore, all of these companies are developing shots to target the original Omicron strain (BA.1) even though it has already been supplanted by other variants (BA.4 and BA.5).
The FDA and these companies claim that shots targeting BA.1 will be effective against later variants but I do not know how they can possibly argue that given the total absence of actual health data.
Words that you will NOT find in the FDA “Future Framework” briefing document:
- original antigenic sin,
- antibody-dependent enhancement,
- prion disease,
- adverse events, or
- side effects.
So the FDA is literally not looking out for any of the worst-case scenario possibilities.
The “Future Framework” is a plan to base the entire COVID-19 vaccine program on magical thinking rather than science.
What’s likely to happen at the VRBPAC meeting on Tuesday, June 28
The cartel is predictable because they follow a playbook and they use the same cast of characters over and over again.
The first presentation will be by CDC staffer Heather Scobie. She will likely take her slides from the June 7 VRBPAC meeting, change the date on the first slide and update them a bit to show that Omicron has become the predominant SARS-CoV-2 variant in the U.S.
The gist will be that there is no point in vaccinating against the “prototype” Wuhan lab leak variant, nor Alpha, Beta, Delta or Gamma, because it’s all Omicron right now.
What she will NOT tell you is that Moderna and Pfizer are designing shots to target the BA.1 version of Omicron and now that variant is waning and being replaced by BA.4 and BA.5. Furthermore, she will not mention the fact that these shots are fueling the evolution of variants that evade any protection from vaccines.
Dr. Scobie will be followed by another CDC staffer, Ruth Link-Gelles who will likely dust off one of her slide decks from the four VRBPAC and four ACIP meetings that have already happened this month and discuss COVID-19 vaccine effectiveness in adults. RLG cracks me up because she absolutely does not give a damn.
She shows slide after slide of negative efficacy from these worthless shots and she does not care because she knows that the VRBPAC will approve anything that has the word vaccine on the vial. RLG’s presentations are a token attempt to play it straight with the data but then all of her data is instantly memory-holed and never spoken of again.
Then, I’ve got to hand it to the cartel for choosing their next speaker — Justin Lessler, from the University of North Carolina. Dr. Lessler has gotten 10 grants from the Bill & Melinda Gates Foundation in recent years (see pages 26 to 30 of his CV here).
Then he’s gotten another 10 grants from NIH and/or Tony Fauci’s National Institute of Allergy and Infectious Diseases (NIAID).
Given that, what are the odds that Dr. Lessler will criticize The Narrative(TM)? Zero.
Gates figured out in 2017 that modeling is the tail that wags the dog of policy and has invested heavily in it ever since.
Dr. Lessler is soaked head to toe in conflicts of interest — he should not be allowed within 100 miles of this committee — and yet the FDA will not even require a conflict waiver from this guy.
Cartel gonna cartel.
After a short break, Stephen Hoge President of Moderna, Dena Swanson, VP of Pfizer, and Greg Glenn, President of Novavax will explain how wonderful their reformulated COVID-19 shots are but they will argue that there is simply no time to conduct proper clinical trials anymore.
None of their data will be peer-reviewed so it will all be fanciful fiction — 95% to 100% efficacy based entirely on belief.
Then the FDA will bring in two closers (and this is where it gets really interesting).
Kanta Subbarao, Director of the World Health Organization (WHO) Collaborating Center in Melbourne, Australia will present “Considerations for Vaccine Strain Composition from the WHO. TAG CO-VAC.”
I did not understand until just yesterday (as 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.
Before joining the WHO, Kanta Subbarao was at NIAID for 14 years, so she’s a loyal lieutenant for Fauci.
She will polish off her slides from the April 6 VRBPAC meeting to argue that COVID-19 is similar to influenza, that strain selection must be coordinated globally and that multivalent New & Improved(TM) COVID-19 Shots Now with Omicron!(TM) will save the day and end the pandemic.
None of her claims will be true but they are what the cartel wants to be said and this is more like a well-funded hostage video than anything else so that’s what we’re going to get.
Finally, the FDA will bring in Jerry Weir, who looks like a cross between Yosemite Sam and Sam Elliott. He’ll slightly update his slides from April as well and then just go round and round with droll observations about the (failed) flu strain selection process and how it should be a model — until the committee is dizzy and willing to agree to anything.
Officially the question that will be voted on is:
“Does the committee recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the United States?”
This language obscures a lot. Boosters are the market now. By calling them boosters instead of reformulated shots (which is what they actually are), they will not go through new clinical trials.
Over the summer, earlier versions of the shot will quietly be withdrawn from the market and the reformulated shots that skipped clinical trials will become the only option. So this is the FDA’s weasel word way of sliding down the slippery slope into no more clinical trials for COVID-19 shots ever again.
If the FDA stated plainly what they are up to there would be riots.
What is to be done
We only have about 24 hours to act so let’s leave it all on the field!
Please submit a formal comment to the regulations.gov website stating that the FDA must reject the “Future Framework” and that all reformulated COVID-19 shots must go through proper human clinical trials. The docket number is FDA-2022-N-0905.
The docket will close Monday night June 27 at 11:59 Eastern time. Click here to go to the relevant page on the regulations.gov website and look for the blue comment button in the upper left-hand corner.
The FDA lies about the number of comments submitted but we have a lawsuit going about that so the more comments we can submit (that they will subsequently hide) the better for our case.
In addition, below are the email addresses of everyone at the FDA/VRBPAC who has a say in this matter. It is our right to share with them our thoughts and concerns about this process. You can share your own story or copy and paste the message below.
Subject line: All reformulated COVID-19 shots MUST go through proper clinical trials
The safety and efficacy of all reformulated COVID-19 shots must be evaluated through:
- Large (50,000+ person) double-blind randomized controlled trials with inert saline placebos conducted by an independent third party.
- The treatment and control groups must be followed for life to monitor adverse events and all-cause mortality (no more wiping out the control group after 6 months to hide bad outcomes).
- We also demand greater than 90% efficacy against infection with less than 0.1% Grade 3 or higher adverse events; proper monitoring for carcinogenesis, mutagenesis and impairment of fertility; and immediate release to the public of all clinical trial documents submitted to the FDA.
email@example.com, firstname.lastname@example.org, 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, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, Jportnoy@cmh.edu, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, RandyHawkins@cdrewu.edu, email@example.com, JYLee@uams.edu, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com
Originally published by Toby Rogers on his Substack page, uTobian.