Five reasons the FDA's June Blitzkrieg Must Fail
Five reasons the FDA's June Blitzkrieg Must Fail
Like any war, the survival of the country will depend on our willingness to fight for what we believe in
I. Overview of the FDA’s planned June Blitzkrieg to authorize useless toxic shots now and forevermore
Let’s talk about the Blitzkrieg that the FDA (read Pharma) is planning for June.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) seems to be taking matters in order of danger (from least to most). This schedule may change but here’s the best guess at this point:
June 7, Novavax in adults. Few people are paying attention to Novavax. Fauci is actively trying to scuttle the application (perhaps so that his preferred mRNA shots cannot be compared to another product?). And there is a sense that unleashing a deadly toxic shot on adults is somehow less morally reprehensible than unleashing this shot on kids (although we all know that authorization in adults is soon followed by authorization in kids). This is the dark horse, I’m not sure what the VRBPAC will do with this one.
June 8, Moderna in 12 to 17 year olds. Now the sledding gets heavier. Moderna applied for Emergency Use Authorization (EUA) back on June 10, 2021. There is a clear safety signal (myocarditis) in the data that has held up the application — and that has not changed. Nordic countries have prohibited its use in this age group. There is no benefit and lots of teenagers will be maimed and die if this use is authorized. Will the VRBPAC have the stones to say no? This should be an easy one (science and ethics both require a vote of No). If history is any guide, a few members will grumble about the data, FDA staff will say something garbled in reply, no one will ask a follow up question, and the shot will be unanimously approved — to “give parents the option” and then ACIP will add it to the childhood schedule and blue states will mandate.
June 21, Moderna in kids 6 to 11 and 0 to 5. This application is a straight up crime against humanity. There is no Covid emergency in this age group (at least 74.2% already have natural immunity). There is no clinically significant health benefit from the shots. The shots cause considerable harms (50% with fevers according to data Moderna leaked to the NY Times). This will be an interesting test for VRBPAC. They should all be consulting criminal defense attorneys right now who will tell them that they will likely be convicted by a jury at Nuremberg 2 if they authorize this use.
June 22, Pfizer in kids <5. Again, if authorized, this is a clear and obvious crime against humanity. There is no Covid emergency in kids. The shot does not work. The shot causes considerable harms. The risk benefit assessment is all harms no benefits.
Dr. Vinay Prasad, who is as mainstream at they get, is openly mocking the corruption at the FDA in a recent Twitter thread (click over to read two connected tweets that are dripping with contempt):
June 28, “Future Framework” for Covid-19 shots. This is an Extinction Level Event for the U.S. The “Future Framework” means that Pfizer and Moderna can reformulate Covid-19 shots however they wish, and the FDA will not require new clinical trial data. Instead the FDA will automatically deem any future Covid-19 formulation as “safe and effective” because it is “biologically similar” to existing Covid-19 shots on the market. If the “Future Framework” is approved, it would represent the end of any clinical trial data on Covid-19 shots, the end of any pretense of science at the FDA, and the end of America. If approved, all-cause mortality will increase for the rest of our lives as Covid-19 shots lead to an increase in heart attacks, cancer, stroke, autoimmune disorders, and a wide range of other chronic and fatal conditions.
My sense is that, at this point, the FDA and VRBPAC are inclined to vote Yes at all five meetings. They are true believers. The Narrative(TM) is far more important to them than science. They cannot admit mistakes lest their entire junk science empire unravel. And right now all of them believe that they will lose their jobs (because Pharma will blacklist them) if they vote No. They are also getting tremendous pressure from the White House to vote Yes. So they will be inclined to follow the path of least resistance (which is what they’ve done their whole lives). FDA staff are surely working feverishly right now to develop elaborate justifications (a LOT of immunobridging) in order to justify these votes.
Our challenge is to make it harder for them to vote Yes and easier for them to vote No.
II. Five Irreconcilable Problems that Doom the FDA’s Blitkrieg
The VRBPAC faces five irreconcilable problems that, if loudly and repeatedly pointed out to them, might sway them to vote No.
1. There is no Covid-19 emergency in kids. Everyone knows this. By definition one cannot grant an Emergency Use Authorization in the absence of an emergency. The FDA will try to gin up scary numbers but everyone knows that in this age group, the Covid-19 risk is similar to (a bit less than) the flu. And no one is declaring that the flu is an emergency. Nearly all fatalities in this age group have multiple underlying comorbidities.
2. The mRNA shots do not work in kids. The Moderna and Pfizer clinical trials in kids showed NO clinically significant health benefit. No reductions in infections, no reductions in hospitalizations, no reductions in ICU visits, no reductions in deaths. They are going to use “immunobridging” to justify these shots — even though every member of the VRBPAC acknowledges that they “lack correlates of protection” (i.e. antibody levels do NOT tell one whether the shot will work or not).
3. mRNA shots cause catastrophic harms in kids. The Pfizer shot has only been available for kids for a short while and there are already 47,736 reports of harms including 106 deaths. Approving a shot with a risk/benefit profile that is 100% risk and 0% benefit would be insanity. The jury at Nuremberg 2 will not look kindly upon those who intentionally harmed children.
We already knew all that (indeed that’s likely why the Pfizer application has already been withdrawn twice). But there are two more factors that tip this debate decisively in our favor.
4. The pandemic will never end as long as the FDA and CDC keep pushing mRNA shots. At the last VRBPAC meeting (where they began discussing the “Future Framework”) one could see this slowly dawning recognition — ‘the shots don’t work, we cannot keep boosting every four months forever, no sterilizing immunity = no herd immunity, we need to reformulate these shots, we have no correlates of protection, but we cannot ask for more data because Big Pharma doesn’t want to provide it.’
The VRBPAC thinks that they can solve this problem by moving to bivalent shots (shots that target two variants instead of just one). But this just compounds their problems. Putting twice as much mRNA into the shots will likely double the side effects (and increase all-cause mortality). Cutting the amount of mRNA in half for each variant (to keep the total mRNA load at 100 mcg for Moderna and 30 mcg for Pfizer) will make these shots even less effective against coronavirus. They’ve checkmated themselves and they don’t even realize it, yet.
Adding to the Kafkaesque absurdity of this whole situation, Moderna is developing a bivalent shot that targets the Wuhan and Beta strains — that are no longer in widespread circulation. Yet Moderna claims that this shot will somehow work against Omicron (and other variants). I mean hey, if you’re just gonna make stuff up, why not just put forward the biggest lie imaginable — it’s a bigger authoritarian flex if people fall for it.
By the time the VRBPAC votes on the “Future Framework” on June 28, Covid-19 shots will have already been on the market for 19 months — and they have made absolutely no difference. Indeed, the evidence now suggests that the shots have negative efficacy and are driving the evolution of variants that evade vaccines. Anyone who is paying attention is starting to realize that the pandemic will never end as long as public health authorities are recommending a shot with negative efficacy.
So no matter how much the VRBPAC hates us, at some point they have to pivot to therapeutics. SARS-CoV-2 was never a good candidate for a vaccine. They CANNOT exit this pandemic via mRNA shots because the virus mutates too fast and mRNA shots make things worse. The VRBPAC can cut their losses now, or later, but if they cut their losses now they can avoid prosecution at Nuremberg 2. The choice is easy, the question is how long they will allow ego to stand in the way?
5. These useless shots, and the failed response to coronavirus in general, are political losers for Democrats. Democratic pollsters have discovered that the Biden administration’s coronavirus plan (everything from lockdowns to masks to shots that do not work) is despised by voters and very well may cost Democrats the midterm elections. So they just don’t talk about it anymore. But that’s not going to be enough to save them.
Pharma has a tepid astroturf campaign going to suggest that parents want these shots in kids under 5. But anyone can see that social media posts to this effect are by paid troll accounts and Op Eds are obviously placed by Pharma PR companies. Only 28% of parents have been gullible enough to inject their 5 to 11 year old kids with this toxic junk. Surveys suggest only 20% of parents will inject their kids under 5. That means that 80 PERCENT OF THE PUBLIC opposes this authorization. Good luck in the midterm elections if you authorize shots opposed by 4 out of 5 voters.
If the FDA proceeds with these authorizations, and Republicans take control of the Congress in November, there is going to be hell to pay . Look for budgets to be slashed. Xavier Becerra, Robert Califf, and Peters Marks will be hauled before oversight committees, chaired by Republicans, who will ask why they ignored the data and intentionally killed and disabled kids. Following the lead of Florida, Republican states will decertify the FDA and create their own regulatory agencies. VRBPAC members would go from heroes (in their own eyes) to pariahs in the space of just a few short months. Authorizing deadly injections for kids very well may cost Democrats the White House in 2024 (as there are now roughly 20 million single-issue medical freedom voters and we have become the largest block of swing voters deciding the outcome of all federal elections).
So the FDA is planning to try to rush this toxic junk through the regulatory process in June so that they can take a long summer vacation, retire in the fall, and be rewarded with lucrative VP jobs at pharmaceutical companies soon thereafter. But if they proceed with their plans to poison all Americans, especially children, in perpetuity, it very well may trigger the largest political backlash in American history.
Which brings me to you.
I need every one of my readers to be on the phone and sending emails, letters, and faxes to political appointees, FDA staff, and VRBPAC members every day for the next 30 days (click on the link in this sentence for contact info). Democracy is a contact sport and we need to break down these information silos so that the FDA can get the vital information that they need. I am asking you to be polite, persistent, and direct. I’ve provided talking points, but telling your own story is by far the most powerful testimony. Our challenge is to find a way to awaken the moral core in these people who right now are sleepwalking through history. The very existence of our country is at stake. If we win, it will be one of the greatest victories for people power in the history of world. So keep the faith and keep battling until truth wins out.
Let’s roll!!!
Blessings to the warriors. 🙌
Prayers for everyone making calls and sending messages every day to stop Pharma fascism. 🙏
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In the comments, please let me know how you are going with contacting these people (and anything else that is on your mind).
As always, please help me to correct any typos.
So just this weekend I received a hand-addressed letter from HHS. Apparently my letter to Dr Califf was forwarded to this person in CBER, and this person was responding to my letter. Of course, I wrote several emails and at least one print letter to Dr. Califf. I assume it was my print letter that warranted the response.
Basically it is a two page letter expressing appreciation for my interest, assuring me that the drug companies are required to continue collecting data and monitoring for myo/pericarditis, that the F D A and C D C are carefully monitoring for serious adverse events, etc, etc.
Unfortunately I now feel like I am on some watch list for future infractions. Given that the letter merely served all the same talking points and was hand-addressed. Maybe I am just paranoid. I mean, it’s unlikely that CBER is used to having to reply to public comment, right? 🤷♀️🤷♀️🤷♀️🤪🤪🤪
Happy to provide more details if those are somehow helpful. Curious if anyone else got hand-addressed snail mail replies. I don’t even get those from my Senator or Congressmen. Lol.
This is a fantastic article! I appreciate hearing about the swamp's plans for the future.