- 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.
Many Are Bailing on Never-Ending Boosters
According to The New York Times:7
“The Biden administration has struggled to convince Americans of the need for successive vaccinations. Only about two-thirds of the population has been inoculated with the primary series of two shots, and far fewer have received booster doses.”
According to the latest U.S. Centers for Disease Control and Prevention statistics,8 262,643,277 Americans have received at least one COVID shot (79.1% of the total population); 108,540,822 have received a first booster dose (48.5%) and 36,323,498 have taken a second booster (33.7%).
But wait, there’s more. As best we can tell, you will not be allowed to get this “new and improved” COVID jab unless you already had your initial two jabs and are double boosted. You simply will not qualify, as they want everyone to get as much of the spike proteins as they can. We won’t know for sure, though, until after the CDC meets this week to decide.
The fact that far fewer people are continuing with the booster madness is a good sign, as it suggests people are finally realizing that the COVID shots aren’t safe OR effective. The entire point of a vaccine is to render you immune against future infection, and getting a booster every three to six months clearly speaks to the failure of these injections to provide any worthwhile protection.
Most COVID cases, especially serious infections, are now also occurring among the “vaccinated,” which further undermines their allure. Only the most brainwashed fail to rethink after having COVID two or three times despite being fully vaxxed and boosted, which today is not a rare event.
According to MSN,9 40% of Americans hospitalized with a SARS-CoV-2 subvariant are fully vaxxed and boosted. Excess mortality statistics also tell a story, with age-adjusted all-cause excess mortality (deaths above the expected norm) nearly tripling since the rollout of the COVID jabs in mid-December 2020.10,11
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
“Independent researchers looking to obtain patient level data from the Pfizer and Moderna COVID-19 vaccine trials may have to wait longer. In status reports filed recently with the US federal trials registry (clinicaltrials.gov) between February and May, both companies extended the dates by which the trials will be completed, Pfizer by nine months, from 15 May 2023 to 8 February 2024.
Moderna’s expected completion date is delayed from 27 October to 29 December, 2022. Pfizer indicated in its trial protocol that individual participant data would be made available two years after study completion.
Now that the date has been pushed back, Pfizer will entertain and review requests ‘when the study is complete and all planned analyses have been performed’ …
Luis Carlos Saiz, a researcher at the Innovation and Organisation Unit of the Navarre Regional Health Service, Spain, said that access to raw patient data was important for researchers because ‘it is key to build trust in health policies and to protect citizens from potential vested interests.’
The raw patient data would allow independent researchers to assess trials and verify results. ‘The vaccination strategies adopted by health authorities all over the world must be audited and checked by looking carefully at the raw data,’ said Saiz, especially given the ‘revelations of poor practices’ at vaccine trial sites as reported by The BMJ.“
The article cites a preprint study that examined the first four months of trial data from Pfizer and Moderna, finding the excess risk of serious adverse events was 12.5 per 10,000 — a far cry from the “1 in 1 million” risk of an adverse event from childhood vaccines.25 (Yes, many of us know the side effect ratio is far higher than that, but that’s what our health authorities claim.)
That is the same data set the FDA used to grant Pfizer and Moderna EUA, and the only data they have upon which to base any safety claims for the reformulated boosters.
Dick Bijl, president of the International Society of Drug Bulletins, also told the BMJ author that in order to assess the risk-benefit ratio for any given group we need the raw data, and we need all of it. As it stands, that data won’t be available until 2025 or so, and in the meantime, we’re flying in the dark.
FDA Clearly Doesn’t Understand the Word ‘Safe’
That doesn’t stop health authorities from making definitive statements, however. For example, in a recent tweet, FDA commissioner Dr. Robert Califf stated:26
“Real world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe. As we know from prior experience, strain changes can be made without affecting safety.”
Again, there are so many things wrong with this statement. Real world evidence shows the COVID shots are actually the most dangerous drugs ever put to market, bar none. Clearly, the FDA has different safety standards than the rest of the world. Perhaps they redefined the word “safe” and didn’t tell anyone?
Furthermore, the notion that “strain changes can be made without affecting safety” refers exclusively to flu shots, not gene therapies. Flu vaccines contain live or attenuated flu viruses grown in eggs or other biological media. You cannot, under any circumstance, assume that an mRNA gene therapy injection — which is not even remotely similar to the flu vaccine — will behave in the same way as a flu vaccine.
False Equivalence Used to Justify Untested Reformulations
Swapping viral strains in a flu vaccine is in no way the same as swapping mRNA instructions. In the case of Pfizer, the reformulated booster will now program your cells to produce two different spike proteins from two Omicron variants, all while your body is likely still producing spike protein from the initial series plus the first two boosters.
We already know the spike protein is the most toxic part of the coronavirus. We’ve already seen the devastating effects of the original spike protein. With your body now producing a total of THREE different kinds of spike protein, how will that affect your biological function?
And here’s the real kicker: The Pfizer jab had 30 micrograms (mcg) of mRNA while Moderna had 100 mcg. The new Pfizer bivalent will now contain 90 mcg of mRNA to make two different kinds of spike protein, and theoretically can be every bit as deadly as Moderna’s original jab.
No one knows how these new spike proteins will affect the human body, and assuming safety based on flu vaccines is beyond idiotic, as the flu vaccine doesn’t program your cells to produce toxic spike proteins. It’s a false equivalence, and Califf surely knows it.
Even Dr. Paul Offit — infamous for making irrational assumptions about vaccine safety — has the good sense to question this line of reasoning. As reported by the New York Post:27
“‘I’m uncomfortable that we would move forward — that we would give millions or tens of millions of doses to people — based on mouse data’ … Paul Offit, told the Journal.28
Offit, an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, believes the comparison between flu shots and COVID-19 shots is not well grounded due to the differences in mutations and protection levels.”
And, for the record, while the CDC initially claimed the spike protein would only be produced for a short amount of time and wouldn’t last long in your body, the agency in early August 2022 deleted that statement from its website — probably because they know it was false, it’s been proven false, and they’re now trying to clean up some of their missteps and blatant lies.
Disclose TV exposed the deletion on its Twitter account,29 with an archived link showing the CDC’s original webpage.
All Flu Shots Will Be Quadrivalent This Year
This fall, expect another major vaccination campaign — possibly even greater than what we’ve seen so far, because in addition to the new COVID booster, they’re also going to push the seasonal flu vaccine again.
Seniors will probably be at greatest risk for vaccine-induced injury and death, as they typically get a high-dose flu vaccine. According to a Danish pilot study, a high-dose quadrivalent influenza vaccine “hinted at morbidity and mortality benefits” for older adults,30 but I don’t think that’ll carry into the real world — especially if given at the same time as a COVID booster.
I can’t even begin to stress how risky it could be to mix an untested bivalent COVID mRNA jab with a high-dose quadrivalent flu vaccine. That’s SIX different antigens being injected into you, where you already might have original spike protein from earlier shots in circulation.
It’s a recipe for disaster, in my opinion. I fear many whose immune function has been compromised and suppressed by the COVID shots might not live to regret their vaccine decisions this winter.
By the way, ALL flu vaccines will be quadrivalent this year,31 meaning they protect against four different influenza strains. There will be no single, bivalent or trivalent versions available. Also keep in mind that multidose vial formulations contain thimerosal32 (mercury) as a preservative, which is yet another health risk.
– Sources and References
- 1 LA Times August 28, 2022
- 2 Sky News August 15, 2022
- 3 New York Times August 31, 2022 (Archived)
- 4 FDA August 31, 2022
- 5, 6, 7 New York Times August 23, 2022
- 8 Covid.cdc.gov, First booster dose 108.5 million, Second booster 23.1 million
- 9 MSN August 25, 2022
- 10 Twitter Ben@US Mortality August 23, 2022
- 11 USMortality.com
- 12, 15, 20 The Atlantic August 25, 2022
- 13 Twitter Dr. Mercola August 28, 2022, response by Sylvester McMonkey McBean
- 14, 26, 27 NY Post August 28, 2022
- 16, 19 FDA.gov June 28, 2022
- 17 Openvaers.com Through August 19, 2022, All territories
- 18 Medical.mit.edu August 17, 2021
- 21 The Defender June 22, 2022
- 22 PHMPT.org Pfizer documents
- 23 PHMPT.org Adverse events legend
- 24 BMJ 2022; 378: o1731
- 25 Chop.edu Vaccine Safety
- 28 STAT News June 29, 2022
- 29 Twitter Disclose.tv August 13, 2022
- 30 Medpage Today August 29, 2022
- 31, 32 CDC Vaccine Supply for 2022-2023 Season
Source: Mercola.com Accessed 6 Sept 22