US Govt Pretends There's a COVID Emergency, Approves New COVID Boosters Without Human Testing. Despite Millions Harmed, Thousands Dead from COVID Clot Shots, CDC/FDA Claim Injections “Proven Safe"
From [MERCOLA]
STORY AT-A-GLANCE
August 31, 2022, the U.S. Food and Drug Administration authorized Pfizer’s and Moderna’s bivalent boosters, which will be available to those who have received the primary two-dose series
Pfizer is releasing a bivalent injection targeting Omicron subvariants BA.4 and BA.5, which are the two currently in circulation. Moderna’s bivalent booster targets the already extinct Wuhan strain and Omicron subvariant BA.1
The reformulated COVID boosters will be rolled out without safety or effectiveness data from human trials. They’re being green-lighted based on antibody data from mice alone, even though antibody levels tell us nothing about effectiveness
According to the FDA, the reactogenicity profile of Pfizer’s reformulated shot is “overall similar to prototype BNT162b2 vaccine,” and VAERS data prove that’s hardly a selling point
This fall, health agencies will also push the seasonal flu shot, and all flu vaccines will be quadrivalent this year, meaning they contain antigens against four influenza strains. Seniors may be at greatest risk for vaccine injury, as they will get a high-dose quadrivalent flu vaccine
As the U.S., U.K. and other countries around the world prepare for a fall vaccination campaign against both the flu and COVID, it’s worth taking note of some basic facts. In “Untested Bivalent COVID Jab Being Rolled Out,” I reviewed potential problems with Moderna’s new bivalent COVID shot for adults, authorized by the U.K. in mid-August 2022.
August 23, 2022, Pfizer and Moderna submitted their respective authorization requests to the U.S. Food and Drug Administration.1 Pfizer is releasing 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.1.2
August 31, the FDA authorized both.3 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:4
“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.”
The reformulated boosters will be available as soon as the U.S. Centers for Disease Control and Prevention gives its OK.5 6 For the record, all boosters, including these, are still under emergency use authorization (EUA) only, so manufacturers have no liability for injuries, and the reformulated shots are being released based on antibody levels in mice alone.
Vaccine Performance Is Not Dependent on Frequency of Use
It remains to be seen how government and media intend to bully people into continuing with this clearly failed strategy, but if The Atlantic is any indication, we can expect Orwellian double-speak and irrational emotionalism to prevail.
According to The Atlantic,12 “Vaccine performance ... depends on how and how often the shots are used. The more people take the doses, the better they will work.” This is merely blatant and outrageous propaganda whose sole purpose is to increase COVID jab adoption. As noted by one Twitter user,13 that’s complete rubbish, as “The performance of a ‘vaccine’ should have NOTHING to do with everyone ELSE taking it.”
The statement that vaccine performance depends on “how often” they’re taken is also clearly misleading if not outright false. No vaccine in history has depended on boosters several times a year, indefinitely. That’s not how real vaccines work. Historically, vaccine booster doses are spaced years apart, if they’re required at all.
New Formulation Is Only Tested on Mice
As mentioned earlier, the reformulated shots will be rolled out long before any data from human trials become available.14 As reported by The Atlantic,15 they’re being green-lighted based on antibody data from mice alone.16 While this has, for years, been the approval protocol for influenza vaccines, these mRNA shots are hardly run-of-the-mill vaccines.
We have no long-term data on them whatsoever, but in the short-term, the original COVID shots have between them resulted in 1,390,594 adverse event reports being logged with the U.S. Vaccine Adverse Events Reporting System (VAERS, data as of August 19, 202217).
That includes 134,245 urgent care visits, 174,371 hospitalizations and 30,479 deaths, and due to widespread underreporting, you have to multiply those numbers by underreporting factor of 41 (or more) to get an idea of the true impact. If you do the math, you will quickly discover that the COVID jabs have been the No. 1 cause of death the past two years, far exceeding heart attacks and cancers that were unrelated to the jab.
“According to the FDA, the reactogenicity profile of the reformulated shot is ‘overall similar to prototype BNT162b2 vaccine,’ and as you can see from the VAERS data, that’s hardly a selling point.”
All of these effects have been swept under the rug and dismissed as unrelated to the jabs, and now they’re going to release reformulated mRNA shots based on nothing but mouse antibody data! It’s been said before, but it’s worth stating again, that antibody levels tell us nothing about effectiveness.
Recall: Antibody tests have been discouraged throughout the pandemic as a means to determine whether the COVID shot is providing protection.18 Why? Because your antibody level cannot tell you whether you’re protected against infection, symptomatic illness and serious illness.
It’s the same here. Antibody levels in response to the COVID shot tell us nothing about its ability to protect against infection and severe illness or death. In classic Orwellian double-speak, they claim that if antibody levels are high after the injection in a trial setting, it’s proof of effectiveness. But don’t waste your time measuring your antibody level, because that won’t tell you anything about your immune protection.
In the "Friday Roundtable" video above, Dr. Meryl Nass, Toby Rogers, Ph.D., and Brian Hooker, Ph.D., expose the injuries and deaths occurring from these jabs, while health officials and media continue to ignore and silence concerns. They review and critique the most recent COVID jab recommendations, the new nontesting framework, various data, and resources for those who want to get involved in the continued fight against medical tyranny.
Bivalent Booster Will Be at Least as Reactive as the Original
So many things can go wrong at this point, I shudder to make predictions. According to the FDA, the reactogenicity profile of the reformulated shot is “overall similar to prototype BNT162b2 vaccine,”19 and as you can see from the VAERS data, that’s hardly a selling point.
The Atlantic, however, downplays the situation by focusing only on the fact that we won’t have any data on effectiveness with which to entice and cajole the public into taking more of these devastating experimental gene therapy shots:20
“... the shortcut does introduce a snag: ‘We know nothing yet about the efficacy or effectiveness of these Omicron-focused vaccines,’ [Mayo Clinic vaccinologist Gregory] Poland said. Researchers can’t be sure of the degree to which the shots will improve upon the original recipe.
And public-health officials won’t be able to leverage the concrete, comforting numbers that have been attached to nearly every other shot that’s been doled out.
Instead, communications will hinge on ‘how much trust you have in the information you’re getting from the government,’ UNC’s [public health researcher Deshira] Wallace told me. ‘And that is very tricky right now.’”
How Pfizer Hid Severe Side Effects
With regard to safety, health authorities claim the original COVID shots have already been “proven” safe, hence the CDC and FDA tell us they don’t need human trial data in order to authorize the reformulated boosters.
Not only do VAERS data negate such statements, we also don’t even have all the data from the original trials yet, and what we do have is beyond terrifying. As reported by Children’s Health Defense (CHD) back in June 2022, court-ordered released FOIA documents reveal Pfizer classified nearly all severe reactions in its trials as unrelated to the shot:21
“The latest release by the U.S. Food and Drug Administration (FDA) of Pfizer-BioNTech COVID-19 vaccine documents22 reveals numerous instances of participants who sustained severe adverse events during Phase 3 trials. Some of these participants withdrew from the trials, some were dropped and some died ...
The CRFs [case report forms] included in this month’s documents contain often vague explanations of the specific symptoms experienced by the trial participants. They also reveal a trend of classifying almost all adverse events — and in particular severe adverse events (SAEs) — as being ‘not related’ to the vaccine ...
The many serious adverse events — and several deaths — recorded during the Phase 3 trials are also apparent in a separate, massive document,23 exceeding 2,500 pages, cataloging such adverse events.
This document lists a wide range of adverse events suffered by trial participants classified as toxicity level 4 — the highest and most serious such level. However, not one of the level 4 (most severe) adverse events listed in this particular document is classified as being related to the vaccination.”
The CHD goes on to list a number of examples from Pfizer’s case reports where participants suffered now well-recognized and common side effects of the jab, such as a teen girl who was diagnosed with right lower extremity deep vein thrombosis, November 15, 2020.
Her condition was still “ongoing” as of March 29, 2021, the date of the CRF. She was hospitalized and her condition listed as “serious.” Still, the CRF indicated the condition was “not related” to the vaccine, but rather due to a “fracture,” which occurred before her injection on September 11, 2020.
Release of Patient Data From COVID Shot Trials Delayed
Some of the most important data — the raw patient data from the initial trials — also won’t be available for release until years in the future. As noted in a recent BMJ article:24 [MORE]