The U.S. Food and Drug Administration (FDA) today, 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.
The “Future Framework” is coming from the World Health Organization, and the Bill & Melinda Gates Foundation is the biggest voluntary contributor to the WHO, so Gates is likely directing the play.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.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are pre-prints or from the CDC’s in-house newsletter Morbidity and Mortality Weekly Report (MMWR) which means they are not peer-reviewed.As I predicted, even though the April 6 meeting was presented as an exploratory initial conversation that reached no conclusions whatsoever, the “Future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.
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.”
Ah, $cience!
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.
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.
- original antigenic sin,
- antibody-dependent enhancement,
- prion disease,
- myocarditis,
- VAERS
- adverse events, or
- side effects.
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 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.
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.
Given that, what are the odds that Dr. Lessler will criticize The Narrative(TM)? Zero.
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).
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.
Before joining the WHO., Kanta Subbarao was at NIAID for 14 years, so she’s a loyal lieutenant for Fauci.
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.
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.
What Is to Be Done
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.- 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.
