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August 31, 2022, the U.S. Food and Drug Administration authorized the reformulated mRNA COVID bivalent boosters, and they didn’t even allow members of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to meet, discuss or vote on the matter
The CDC’s Advisory Committee on Immunization Practices (ACIP) met for eight hours September 1, 2022, and authorized the untested boosters 13-to-1. CDC director Rochelle Walensky endorsed the recommendation later that evening
Pfizer’s new booster is a bivalent injection targeting Omicron subvariants BA.4 and BA.5, which are the two currently in circulation, while Moderna’s shot targets the already extinct Wuhan strain and Omicron subvariant BA.1
The bivalent boosters will only be available to those who have already received the primary two-dose series and/or a monovalent booster at least two months ago
Pfizer’s bivalent booster was tested on a total of eight mice, and they only checked antibody levels, even though antibodies cannot tell you whether the shot actually protects against infection and symptomatic and/or serious illness. Moderna also used mice to ascertain antibody responses, but has not disclosed the number of mice used
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With their authorization of reformulated COVID mRNA boosters without the standard steps of testing,1 the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have completely abandoned science. They’re both simply rubber stamping whatever the drug industry wants to do, without any concern for public health whatsoever.
August 31, 2022, the FDA authorized the reformulated shots,2 and they didn’t even allow members of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to meet, discuss or vote on the matter.
Instead, they pushed the matter before the CDC’s Advisory Committee on Immunization Practices (ACIP). ACIP met for eight hours September 1, 2022, and authorized the untested boosters 13-to-1.3,4 CDC director Rochelle Walensky endorsed the recommendation later that evening. As reported by Yahoo! News:5
“Because the Biden administration has pushed for a fall booster campaign to begin in September, the mRNA vaccine-makers Pfizer-BioNTech and Moderna have only had time to test the reformulated shots in mice, not people.
That means the Food and Drug Administration is relying on the mice trial data — plus human trial results from a similar vaccine that targets the original omicron strain, called BA.1 — to evaluate the new shots …
That could be a potentially risky bet, experts say, if the shots don’t work as well as hoped … the lack of data in humans means officials likely won’t know how much better the new shots are — if at all — until the fall booster campaign is well underway.
What You Need to Know About the New Boosters
Pfizer’s new booster is a bivalent injection targeting Omicron subvariants BA.4 and BA.5, which are the two [alleged] currently in circulation, while Moderna’s shot targets the already extinct Wuhan strain and Omicron subvariant BA.1.6 The bivalent boosters will only be available to those who have already received the primary two-dose series and/or a monovalent booster at least two months ago. Per the FDA:7
“The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older …
With today’s authorization, the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older … These monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older …
Individuals 18 years of age and older are eligible for a single booster dose of the Moderna COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
Individuals 12 years of age and older are eligible for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.”
No One Can Predict Safety of These Bivalent Boosters
For the record, these bivalent boosters are STILL under emergency use authorization (EUA) only, so manufacturers have no liability for injuries. This despite the fact that we now know that:
a) The lethality of COVID-19 was nowhere near what was initially feared (something Bill Gates is now openly admitting. A clip of him is included in “The Jimmy Dore Show” episode above)
b) The COVID shots increase your risk of COVID and prevent natural immunity from developing when you do get infected
c) The shots impair immune function in general, raising your risk of other infections and chronic diseases
d) We’re not in an emergency; COVID is now endemic and typically presents as a mild cold
e) Since the COVID shots are leaky, i.e., they cannot prevent infection, we cannot vaccinate our way out. As VRBPAC member Dr. Paul Offit recently told Science magazine,8 “Even if 100% of the population were vaccinated and the virus hadn’t evolved at all, [COVID] vaccines would do very little to stop transmission”
f) There are plenty of effective treatments, which by law negates the basis for EUA vaccines
According to the FDA, the reactogenicity profile of the reformulated shot is “overall similar to prototype BNT162b2 vaccine,”9 and based on U.S. Vaccine Adverse Events Reporting System (VAERS) data, that’s hardly comforting.
As of August 26, 2022, VAERS has received 1,394,703 reports of adverse effects following the COVID jab,10 up from 1,390,594 the week before. That includes 134,530 urgent care visits, 175,020 hospitalizations and 30,605 deaths (up from 30,479 deaths as of August 19).
The real-world carnage is far worse than that though. Due to widespread underreporting, you have to multiply those numbers by an underreporting factor of 41 (or more) to get to closer to the true numbers. If you do the math, you will discover that the COVID jabs have been the No. 1 cause of death in the U.S. for the past two years, far exceeding heart attacks and cancers that were unrelated to the jab.
They are the deadliest drugs in medical history, bar none, and now reformulated shots are being green-lighted based on antibody data from mice alone!11,12 As Dore jokingly states, “It’s been tested on mice, now put it in your baby.” What could go wrong?
Mouse Antibody Levels Tell Us Nothing About Effectiveness
Pfizer’s bivalent booster was tested on a total of eight mice, and they only checked antibody levels. Moderna also used mice to ascertain antibody responses, but have not disclosed the number of mice used.13
But while the FDA, CDC, Pfizer, Moderna and the rest of this criminal cabal claim that mouse antibody levels are a testament to effectiveness, that’s simply not so. Your antibody level cannot tell you whether you’re protected against infection, symptomatic illness and serious illness.
This is why antibody testing has been discouraged throughout the pandemic as a means to determine whether the COVID shot is actually protective.14 Making matters even more ridiculous, Pfizer isn’t even releasing what little animal data they do have on this bivalent booster.
As crazy as it is, the FDA and CDC are now treating experimental gene therapy shots like regular flu vaccines.15 The seasonal flu vaccine is updated annually, without ever undergoing any additional safety or even efficacy testing. Efficacy is calculated after the fact. The COVID shots are now going to be updated, indefinitely, using that same process.
The problem is, you simply cannot compare the safety of changing the influenza virus included in the flu vaccine with the modification of mRNA included in a COVID shot, because they’re two very different technologies. The flu vaccine doesn’t program your body’s cells to produce a toxic spike protein.
When you change the mRNA, you change the spike protein produced, and without proper testing, there’s no way of knowing if the Omicron spike proteins will affect human biology the same way as the original spike protein, if they’ll be safer or more dangerous.
The Spike Protein Cover-Up
The CDC has lost all credibility, and no amount of internal reorganization will fix what dishonesty and anti-scientific recommendations have broken. As noted by Center for Food, Power and Life director Jon Sanders in a September 1, 2022, American Institute for Economic Research (AIER) article,16 CDC “facts” have a tendency to not age well these days.
They’re constantly updating their COVID webpages, tweaking verbiage to conform to the current narrative while memory-holing previous statements:
“November 23, 2020, the Centers for Disease Control and Prevention (CDC) published information on something that was on everybody’s mind: vaccines against COVID-19.
In a page titled ‘Understanding mRNA COVID-19 Vaccines,’ the CDC wanted everyone to know what to expect with the coming vaccines, which were being put forth under ‘Emergency Use Authorization’ … the FDA and CDC assured everyone they would be ‘rigorously tested’ and ‘rigorously evaluated for safety.’
Also, since the first vaccines to be rolled out would be messenger RNA (mRNA) vaccines … never before licensed for use in the U.S., the CDC wanted to explain to everyone how they would work. The CDC explained the difference in vaccine types this way:
‘To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. Not mRNA vaccines. Instead, they teach our cells how to make a protein — or even just a piece of a protein — that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies’ …
The CDC also provided ‘A Closer Look at How COVID-19 mRNA Vaccines Work’ to put people’s minds at ease about the new kind of vaccine … From there we learned several things about the mRNA vaccines:
- They cause our cells to make … the ‘spike protein’ used by the virus that causes COVID.
- This spike protein is harmless (the CDC emphasized that fact with bold text).
- The vaccine is injected in the upper arm muscle. Only the upper arm muscle cells … make the harmless spike protein.
- An upper arm muscle cell makes only one harmless protein piece, then it breaks down the mRNA ‘instructions’ and gets rid of them.
- The muscle cell displays the harmless protein piece.
- The immune system recognizes the harmless protein piece is unnatural and builds up antibodies to it.
- The immune system is now prepared to fight against an invasion by the real deal sporting that spike protein.”
Cha-Cha-Changes
Since November 2020, this and other CDC webpages covering COVID topics have undergone a large number of stealth revisions. For example, October 1, 2021, the CDC added the following section:
“COVID-19 vaccines are not interchangeable. If you received a Pfizer-BioNTech or Moderna COVID-19 vaccine, you should get the same product for your second shot.”
Between October 18 and October 31, that section first changed to “You should get the same product for your second shot,” and later, “You should get the same product when you need another shot.”
As noted by Sanders, “This was the month in which CDC began to hedge on the total number of shots necessary to be considered ‘fully vaccinated.’” But then, November 3, when the CDC began promoting boosters, it changed the text again, now suddenly claiming that boosters did NOT need to match the product used for the primary series. Where’s the science to back that up?
In late October, the CDC also updated its “How mRNA Vaccines Work” section, adding: “Any temporary discomfort experienced after getting the vaccine is a natural part of the process and an indication that the vaccine is working.” They also changed its “Facts About COVID-19 mRNA Vaccines” sidebar, adding a third fact-heading that stated:
“The mRNA and the spike protein don’t last long in the body. Our cells break down the mRNA and get rid of it within a few days after vaccination. Scientist estimate that the spike protein, like other proteins our bodies create, may stay in the body up to a few weeks.”
Before this, CDC adherents had likely assumed the spike protein vanished as rapidly as the mRNA. Then, in mid-June 2022, another round of revisions was made. Sanders writes, in part:17
“This update made two changes to the ‘How mRNA Vaccines Work’ section. It no longer used bold text to stress that the spike protein is ‘a harmless piece,’ even though it had done that consistently from the very beginning.
A bigger change was made to the ‘Any temporary discomfort’ sentence added in October 2021. Formerly that sentence read (emphasis added): ‘Any temporary discomfort experienced after getting the vaccine is a natural part of the process and an indication that the vaccine is working.’
The new sentence read (emphasis added): ‘Any side effects from getting the vaccine are normal signs the body is building protection.’ Readers were to adjust their expectation of natural/normal. Not ‘temporary discomfort’ but ‘side effects,’ and not a definitive ‘the vaccine is working’ but a more vague ‘the body is building protection.’”
CDC’s Biggest Fact U-Turns to Date
Fast-forward another month, and in mid-July 2022, the CDC was busy revising its COVID pages yet again. Importantly, they completely expunged the “fact” about mRNA and spike protein not lasting long in the body. So, as noted by Sanders:
“Our knowledge of the vaccines from the CDC has undergone great changes since November 2020:
- The CDC is no longer so confident that the protein our cells are caused to manufacture by the mRNA vaccines is harmless that they display it in bold text.
- The CDC no longer argues that our cells break down the mRNA soon after making the spike protein.
- The CDC no longer says the spike protein may stay in the body only for a few weeks.
The constant churn of revisions leaves us with many questions, when the whole point of producing a page entitled ‘Understanding mRNA COVID-19 Vaccines’ was to prevent such a thing. They are, unfortunately, very big questions.
What does it mean if our cells don’t break down the mRNA and remove it soon? What does it mean if the spike protein they produce stays in the body much, much longer than we were originally told? Do they even know how long? What kind of lasting effects can vaccinated people expect? Are those effects exacerbated by boosting and continued boosting?
How prevalent are the effects? Do they differ for different people, and if so, by how much? Are those effects greater for small children? And are those effects at all related to the disturbing rise in non-COVID excess deaths in the U.K., Australia, and the U.S.?”
CDC Asked Facebook to Censor Claims It Has Since Revised
One of the biggest walk-backs among all these revisions is the CDC’s deletion of the claim that the spike protein is harmless and doesn’t last long in your body. A year earlier, in late July 2021, the CDC was in communication with Facebook, giving it talking points with which to debunk and censor claims that spike protein in the COVID shots is dangerous and cytotoxic. In a July 28, 2021, email, a CDC official provided the following counter-narrative:18
“Messenger RNA (mRNA) vaccine are one type of COVID-19 vaccine. Messenger mRNA [sic] vaccines work by teaching our cells to create a harmless spike protein …” (Emphasis in the original.)
The CDC also gave Facebook counter narratives with which to censor and debunk the claim that the shots could cause myocarditis, and that VAERS is a good source for evaluating vaccine adverse effects and related deaths.19
COVID Shot Recommendations Are a Crime in Progress
In the final analysis, what the FDA and CDC have done to the American people is an unspeakable atrocity and an unforgiveable crime. They’ve lied about and obfuscated the facts. They’ve ignored science and tossed the precautionary principle out the window.
They’ve circumvented every possible rule designed to ensure safety. They’ve rewritten both history and the definition of medical terminology. They’ve operated outside the law and violated the Constitution, and to this day, they continue to put people’s health and lives at risk — all so that drug companies can cash in on drugs that don’t work, at least not for more than a few weeks.
Anyone who believes fewer than 10 mice is sufficient to determine safety and efficacy of reformulated mRNA gene therapy does not belong in a public health position and, apparently, that’s all but one person.
It’s truly unbelievable that only one ACIP member objected to this clear and apparent madness, but that’s where we are. If you are eligible for these bivalent boosters, I would suggest you think long and hard before going down that road. Of course if you read this newsletter you likely already do think before you go there. Fortunately an ever-increasing percentage of the population is also following your lead.
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Notes
1, 5 Yahoo.com August 31, 2022
2 New York Times August 31, 2022 (Archived)
3, 13 Rumble, Friday Roundtable September 2, 2022
4 Pharmacy Practice News September 1, 2022
9, 11 FDA.gov June 28, 2022
10 Openvaers.com Through August 26, 2022, All territories
12 The Atlantic August 25, 2022
14 Medical.mit.edu August 17, 2021
16, 17 AIER September 1, 2022
18, 19 Ago.mo.gov CDC emails to Facebook July 2021
Featured image is from Mercola
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