September 11, 2023, the U.S. Food and Drug Administration announced1 it had approved reformulated monovalent COVID shots by Pfizer and Moderna for the fall for use in individuals 12 years of age and older. But don’t be fooled. The Public Readiness and Emergency Preparedness (PREP) Act liability shield for the COVID-19 vaccines will remain in place through Dec. 31, 2024.2
So, “approved” or not, the manufacturers, distributors and providers that administer the shots still won’t be liable for injuries. The agency has also issued emergency use authorization (EUA) for use of the reformulated jabs in children aged 6 months to 11 years.3
Reformulated Shots Are Obsolete Out of the Gate
The updated mRNA injections contain a single modified RNA said to correspond to the Omicron variant XBB.1.5., which was the dominant variant in the U.S. for most of 2023, but which has since been replaced by other variants.
According to cardiologist Dr. Peter McCullough, XBB.1.5 accounted for just 3.1% of the circulating strains as of September 2, 2023, and is “expected to be extinct by the time any American is injected.”4
The dominant strains right now are EG.5 and FL.1.5.1, and “There are no randomized clinical trials demonstrating either Pfizer or Moderna XBB.1.5 boosters would work” against these newer strains, McCullough told The Defender.5
Physician and biochemist Dr. Robert Malone agrees, adding that the newer variants appear to “have evolved even further to escape the antibody pressure elicited by the globally deployed leaky ‘vaccines.’”6,7
Linda Wastila, Ph.D., a professor of geriatric pharmacotherapy at the University of Maryland School of Pharmacy and director of research for the Peter Lamy Center for Drug Therapy and Aging, also criticized the decision to roll out yet another obsolete booster:8
“I do not understand why public health and political leaders are advocating for a booster that is already obsolete. The approved and authorized boosters are like dogs chasing their tails — the mild variants they are supposed to help mitigate serious disease are already waning, already being overtaken by the next generation of mild, mutated viruses.”
Shot Recast as ‘Annual Vaccine’ to Counter ‘Booster Fatigue’
According to authorities, however, this strain is different enough from the strains in any of the previous shots to recommend everyone take it, regardless of your previous COVID jab history.9 Within days of the FDA’s announcement, New York Gov. Kathy Hochul warned New Yorkers that previous shots “will not help you” against the coming COVID wave.10,11
“It doesn’t matter if you’ve already been vaccinated. Take no comfort in that. Thank you for getting vaccinated in the past, but that is not protecting you today. Tell everybody: don’t rely on the fact that you had a vaccine in the past, it will not help you this time around,” she said during a September 13, 2023, press briefing.
What she left out, of course, is that the new shots probably won’t help you either, and even if they do, the protection you get will wane within a handful of months and leave you even more vulnerable to infection,12 hospitalization and death than you were before.13
Remarkably, they’re using the same bogus narratives as the first time, even though the facts are now on the table for everyone to see. We’re not speculating anymore when we say the shots are ineffective and cause more harm than good. We’re not speculating when we say they’re causing heart problems and injure immune function — and that these effects are far from rare.
It’s all documented in the scientific literature. Yet government leaders pretend as if those data don’t exist, and run through the same old arguments that have been debunked many times over. Time will tell whether Americans are foolish enough to fall for the same lies a second time.
As reported by The New York Times, Americans are, by and large, fed up with the COVID boosters, which is why federal officials “have been retreating from labeling the new formulation as boosters to previous shots, preferring to recast them as an annual immunization effort akin to the flu vaccine.”14
Chances are, this tactic will fail because the FDA has already announced that this new shot will require multiple doses for certain age groups, and you’d have to be really naïve to think that more boosters won’t follow after that.
Previously jabbed children between the ages of 6 months and 4 years, for example, are slated to get two doses (depending on the brand), and unjabbed children in this age group would get up to three doses.15 So, they’re just restarting the whole injection series all over again, but in much younger age groups.
COVID Jab Testing Has Been Far From Rigorous
Perhaps one of the most egregious lies is that the shots have undergone rigorous human testing. What they’re referring to here are the human trials conducted in 2020 which, notably, did not have a control group. They destroyed the control group by offering everyone the real shot mere months into the trial.
Even so, data released through Freedom of Information Act (FOIA) requests show Pfizer documented16,17 158,000 different “side effects of special interest” in its trials, all while claiming there were no safety concerns.
Documents also reveal Pfizer received 42,086 adverse event reports, including 1,223 deaths, in the first three months of the rollout of the shot (December 2020 through the end of February 2021).18,19 The 1976 swine flu vaccine was pulled after only 25 deaths.
The bivalent boosters20,21 that came next were only tested on mice, which tells you nothing about their safety. Moreover, their effectiveness was gauged based on antibody titers alone, which doesn’t tell you anything about effectiveness in the real world. This was true both for Pfizer and Moderna.
Pfizer’s New Shot Has Only Been Tested on Mice
As for the brand-new reformulated monovalent shot against XBB.1.5., Pfizer’s testing has again only involved mice — 10 mice, to be exact — while Moderna’s version has been tested on 50 adults.22
Some have reported the trial had 100 participants,23 but only 50 received the monovalent XBB.1.5 shot now being rolled out. Another 51 received a bivalent shot containing a mix of BA.4/5+XBB.1.5. So there was no control group.
One person in the XBB.1.5 treatment group reportedly experienced a serious adverse event, giving us a potential serious adverse event rate of 1 in 50. What’s more, they only reported side effects that occurred within 14 days of injection,24 so we have no idea how bad it might be in the longer term. As reported by the New York Post, September 14, 2023:25
“What if I told you one in 50 people who took a new medication had a ‘medically attended adverse event’ and the manufacturer refused to disclose what exactly the complication was — would you take it? And what if the theoretical benefit was only transient, lasting about three months, after which your susceptibility goes back to baseline?
And what if we told you the Food and Drug Administration cleared it without any human-outcomes data and European regulators are not universally recommending it as the Centers for Disease Control and Prevention is? That’s what we know about the new COVID vaccine the Biden administration is firmly recommending for every American 6 months old and up.
The push is so hard that former White House COVID coordinator Dr. Ashish Jha and CDC head Mandy Cohen are making unsupported claims the new vaccine reduces hospitalizations. long COVID and the likelihood you will spread COVID. None of those claims has a shred of scientific support …
The questions surrounding Moderna’s new COVID vaccine approved this week are still looming. Pfizer’s version, approved this week as well, also has zero efficacy data and has not been tested on humans at all. We only have data about antibody production from 10 mice.
The FDA, or Moderna (frankly, it’s hard to tell the difference sometimes), should disclose what happened to the patient who took the new vaccine and had a complication that required medical attention. The public has a right to know.”
What Does the Science Show?
The New York Post article, written by Dr. Marty Makary, a surgeon and public policy researcher at Johns Hopkins University, and Dr. Tracy Beth Hoeg, an epidemiology and public health researcher at the University of California, goes on to review several of the studies and systematic meta-analyses published over the past couple of years, showing the shots:
• Don’t protect against COVID for more than a few months and make you more prone to infection, hospitalization and death once protection wanes26,27,28,29,30
• Don’t outperform natural immunity (in fact, natural immunity appears to offer better protection)31
• Have a horrendous safety profile — The German Paul-Ehrlich-Institute concluded the shots have a serious adverse event rate of 1 in 5,000 doses.32 Another study estimated the rate of serious adverse events may be as high as 1 in 556 recipients.33
A risk-benefit analysis by Makary and his team published last year also concluded that the college booster mandates resulted in net public harm, injuring at least 18.5 people for every COVID-related hospitalization prevented, plus 1,430 to 4,626 cases of side effects that are problematic enough to interfere with daily activities34
Annual COVID Jab Recommendation Is Insane
Commenting on the U.S. government’s inexplicably lackadaisical attitude toward safety, Makary and Hoeg write:35
“If public health officials get their way, a healthy 5-year-old boy will get 72 COVID vaccine shots over the course of his lifetime, if he has an average lifespan, with a risk of myocarditis after each one. Inexplicably and defying science, the CDC is saying even if a child had COVID three weeks ago, he or she should still get the new COVID shot.
Two of the FDA’s best vaccine experts are gone. Dr. Marion Gruber, who was director of the FDA’s vaccine office, and her deputy director, Dr. Philip Krause, both quit the agency in 2021 in protest over political pressure to authorize vaccine boosters for young people.
Ever since the loss of these two vaccine experts, the agency’s vaccine authorizations have been consistent with an overly cozy relationship between pharma and the White House.
Pushing a new COVID vaccine without human-outcomes data makes a mockery of the scientific method and our regulatory process. In fact, why have an FDA if White House doctors can simply declare a drug to be safe after discussing secret data in private meetings with pharma?
If public health officials don’t want a repeat disappointing turnout of Americans who get the COVID booster shot, they should require a proper clinical trial to show the American people the benefit. Public health leaders cannot afford to squander any more credibility and money on interventions with no scientific support.”
Unethical and Indefensible Decisions
Fortunately, the pushback against the FDA’s decision to approve and authorize (under EUA) the reformulated COVID shot without scientific support is widespread and growing. Wastila, for example, commented on the agency’s decision:36
“It is unethical to continue to approve and authorize mRNA vaccines for COVID-19 when the pandemic has disappeared. It is unethical to promote these boosters as safe and effective when it is clear they are not, and the government is ignoring evidence that the vaccines can provide considerable harm.
The fact that these vaccines were authorized for children when a public health emergency no longer exists is unconscionable …
Both Moderna and Pfizer have failed to deliver on promised post-marketing studies [from prior COVID-19 vaccines]. We have yet to see the results from the bivalent vaccine safety studies in pregnant women; the myocarditis studies in young people also have not been completed nor have most results been shared.”
Dr. Pierre Kory, president and chief medical officer of the Front Line COVID-19 Critical Care Alliance (FLCCC), issued a similar statement:37
“It is unconscionable that the government can recommend this booster for 6-month-olds when the FDA has no data on how children might be affected. There is no need to vaccinate healthy children for COVID-19. To give them an untested booster goes against everything we are trained to do as physicians.”
Canadian physician Dr. William Makis agreed, stating:38
“There is no ‘COVID-19 emergency’ for children, therefore there is no legitimate scientific basis for an ‘emergency authorization’ of a new COVID-19 booster in this age group. Any doctor still administering COVID-19 mRNA vaccines to children of any age is engaging in medical malpractice.”
DNA Contamination Confirmed
In April 2023, microbiologist Kevin McKernan reported his team had found simian virus 40 (SV40) promoters in Pfizer’s and Moderna’s bivalent mRNA COVID shots.39,40,41,42 SV40 has for decades been suspected of causing cancer in humans,43 so finding SV40 promoters in the shots was rather shocking.
But that’s not all. They also found DNA contaminants in the vials, which have the ability to alter the human genome. It’s been assumed that the COVID shots contained only RNA, but using genomic sequencing, McKernan discovered they contain DNA fragments as well, and there really should not be any. The RNA is basically copied, or “Xeroxed” off the DNA, and only the RNA should be in the final product. Several other labs have since confirmed McKernan’s findings.
September 13, 2023, University of South Carolina professor Phillip Buckhaults testified44 before the South Carolina Senate Medical Affairs Ad-Hoc Committee on the Department of Health and Environmental Control (DHEC).
His testimony is featured in the video at the top of this article. Buckhaults is a molecular biologist and cancer geneticist with extensive experience in DNA sequencing, and he too has found foreign DNA plasmids in the COVID shots.
In his testimony, he explains why and how these DNA contaminants can integrate into your genome and disrupt the function of other genes, either long term or permanently. This risk has been known for decades,45 and one potential result is the induction of cancer.
He stresses that it’s important to collect and analyze DNA from various tissues of those who have received the COVID jabs — at least a few hundred people — to determine whether genomic integration is taking place, and what changes are occurring.
Buckhaults also explains how the DNA contamination occurred in the first place, and reviews the bait and switch that allowed this to happen. In summary, the products used during the clinical trials and the commercial product were not made in the identical way. The commercial product grew modified RNA using DNA plasmid and E. coli, and the DNA were not properly filtered out — a clear sign of poor manufacturing processes.
Sources and References
- 1, 15 FDA September 11, 2023
- 2 HHS.gov Fact Sheet April 14, 2023
- 3, 4, 5, 6, 8, 23, 36, 37, 38 The Defender September 12, 2023
- 7 RW Malone Substack September 12, 2023
- 9 Scientific American September 1, 2023
- 10 American Military News September 13, 2023
- 11 CBS News September 13, 2023
- 12, 28 Open Forum Infectious Diseases June 2023; 10(6): ofad209
- 13, 27 KFF November 30, 2022
- 14 The New York Times September 11, 2023
- 16 Peckford42 WordPress March 3, 2022
- 17 Pfizer Side Effects List
- 18 YouTube John Campbell, The Pfizer Documents
- 19 PHMPT.org Pfizer Documents
- 20 NBC News August 30, 2022
- 21 Health.com September 7, 2022
- 22 CDC.gov Safety and Immunogenicity of Moderna 2023-2024 Formula Monovalent XBB1.5 September 12, 2023 ACIP Presentation
- 24, 25, 32, 33, 35 New York Post September 14, 2023
- 26 Science June 14, 2022
- 29 WJS January 1, 2023
- 30 Food Chem Toxicol June 2022; 164: 113008
- 31 The Lancet February 16, 2023
- 34 Journal of Medical Ethics December 5, 2022; medethics-2022-108449
- 39 OSF Preprints April 10, 2023, Edited April 11, 2023 DOI: 10.31219/osf.io/b9t7m
- 40 Twitter KanekoaTheGreat May 20, 2023
- 41 Anandamide (Kevin McKernan) Substack May 20, 2023
- 42 The Healthcare Channel May 22, 2023
- 43 Expert Rev Respir Med October 2011; 5(5): 683-697
- 44 Jessica Rose Substack September 18, 2023
- 45 Ann N Y Acad Sci November 27, 1995; 772: 140-151
- 46 Covid19criticalcare.com
