CDC, Pharma Giants Angle for Annual COVID Shots Despite ‘Unclear’ Science
By Monica Dutcher | The Defender | August 7, 2023
The U.S. House of Representatives Select Subcommittee on the Coronavirus Pandemic wants to know more about plans by the Centers for Disease Control and Prevention (CDC) to recommend annual COVID-19 vaccines.
During a July interview with Spectrum News, CDC Director Mandy Cohen said she “anticipate[s] that COVID will become similar to flu shots, where … you get your annual flu shot and you get your annual COVID shot.”
As part of the House investigation into federal COVID-19 vaccination mandates and policies, Rep. Brad Wenstrup (R-Ohio) last week sent a letter to Cohen, stating:
“It is unclear if the science supports such a recommendation. If this anticipated CDC recommendation occurs, it will mark a significant change in federal policy and guidance regarding COVID-19 vaccines and the way in which they are utilized.”
Wenstrup requested all documents and communications about any annual — “or any other time-based iteration” — recommendation for COVID-19 booster shots, including correspondence between or among the CDC, U.S. Department of Health and Human Services (also under the subcommittee’s investigation), the White House, the CDC Foundation, CDC contractors and any other CDC stakeholders.
Pfizer, Moderna and Novavax are slated in September to release new single-strain COVID-19 shots targeting the Omicron subvariant XBB.1.5. These vaccines are not yet approved by the U.S. Food and Drug Administration (FDA), but manufacturers are following the June 15 recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).
The committee of 21 independent advisers in June voted unanimously that any new vaccine should protect against just one strain of the virus — a departure from the available bivalent vaccines — and should target one of the three Omicron subvariants currently circulating, including XBB.1.5.
The XBB.1.5 variant spread globally in the first quarter of 2023, reaching dominance in North America, and other parts of the world by April, according to the FDA’s briefing document for the June meeting.
‘We really don’t know what the COVID season is’
FDA advisers in January raised concerns about shifting to a yearly schedule for COVID-19 vaccines. Unlike the flu, which thrives in the winter months, COVID-19’s spread has proved erratic, consistently mutating into new variants.
Dr. Mark Sawyer, professor of clinical pediatrics at the University of California, San Diego, told CNBC that describing COVID-19 as seasonal “could be problematic” because “we really don’t know what the COVID season is.”
Dr. Peter McCullough, author of “The Courage to Face COVID-19: Preventing Hospitalization and Death While Battling the Bio-Pharmaceutical Complex,” told The Defender :
“COVID-19 respiratory illness is now like a mild head cold. There is no seasonal pattern. The COVID-19 vaccines have failed to stop transmission or protect against hospitalization and death.
“The products on the market have theoretical efficacy of less than six months. Annual COVID-19 shots have no clinical indication, medical necessity, are not durable for 12 months and have never been tested for use on a yearly schedule.
“On Dec. 7, 2022 in a U.S. Senate panel on vaccines, I called for all COVID-19 vaccines to be removed from the market because they are not safe for human use. There has been no objection to that testimony from public health officials.”
NBC News reported that Dr. Peter Marks, the FDA’s top vaccine regulator, acknowledged during an FDA advisory committee meeting in January that “simplifying the COVID-19 vaccine schedule to be exactly like the flu may not be possible.”
Pfizer hopes otherwise. The drug company’s chief scientific officer, Dr. Mikael Dolsten, thinks an annual COVID-19 vaccine would improve vaccine sentiment, telling CNBC the public grew dissatisfied with mandates during the earlier stages of the pandemic.
He said:
“Unfortunately some people see vaccines as part of that [the mandates].
“I think of it like the introduction of seat belts for cars. People didn’t want to wear them at first, but over time they realized how much seat belts protect them. Now everyone uses them today. That’s kind of how the vaccine story needs to be reimagined.”
An annual schedule, Dolsten added, may help people view COVID-19 shots as another “very natural part” of protecting their health.
CDC director ‘very worried about parents not vaccinating kids’
In addition to the ambiguity surrounding COVID-19 vaccine scheduling, there is no consensus among medical experts on which patients would be recommended for an annual jab.
Dr. Paul Offit, a vaccine scientist, professor of pediatrics in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia and a member of VRBPAC, took issue with not only the annual model but also with administering COVID-19 vaccines to low-risk groups.
Offit told CNN:
“If the goal of the vaccine is the stated goal, which is protection against severe disease, do you really need a yearly vaccine for otherwise healthy people less than 75? I mean, is this the flu model? Because I would argue it shouldn’t be.”
Health advocacy groups and doctors argue against authorizing mRNA shots in young children and babies. As of July 28 — when data were last updated in the Vaccine Adverse Event Reporting System (VAERS) — there were 6,591 reports of adverse events following COVID-19 vaccination in children under age 6.
Cohen said she is “very worried about parents not vaccinating kids,” telling Spectrum News, “There’s plenty of other things that are hard as parents that we can’t do. This is one we can do to protect our kids.”
McCullough described Cohen as “fully entrenched in the bio-pharmaceutical complex” and “on the wrong side of every pandemic public health intervention.”
Jeffrey A. Tucker, founder and president of the Brownstone Institute, said Cohen’s career has been punctuated by “heartbreaking fear-mongering, pseudo-science, and propaganda,” adding that “she passed with flying colors all three tests of compliance: closures, masking, and vaccine mandates.”
Reduced trust in vaccines and the CDC concerns Cohen, who plans to rehabilitate that trust by focusing on “transparency, execution and building relationships with the public, health leaders and politicians.”
A survey by the Harvard T.H. Chan School of Public Health published in the journal Health Affairs found that roughly a quarter of Americans have little to no trust in the CDC for health information, including 10% who do not trust the agency at all.
The CDC currently recommends the primary series of mRNA shots, or the first two doses of the updated vaccine be given weeks apart, followed months later by a booster shot. The FDA updated its guidance for these shots in August 2022 to contain a bivalent formulation targeting the original viral strain plus the BA.4 and BA.5 Omicron subvariants.
Pfizer is working on a combined flu/COVID-19 vaccine, expected to be available after 2024. Moderna is also working on a “next-gen flu-COVID combo” vaccine. Other vaccine makers are following suit.
Monica Dutcher is a Maryland-based senior reporter for The Defender.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
1,700+ demand retraction of influential COVID-19 origins paper after emails reveal authors doubted their own conclusions
By Suzanne Burdick, Ph.D. | The Defender | July 26, 2023
More than 1,700 people have signed a petition calling for the retraction of the seminal scientific correspondence paper, “The proximal origin of SARS-CoV-2,” that claimed COVID-19 was “not a laboratory construct or a purposefully manipulated virus.”
The paper — sometimes referred to as the “Proximal Origins” paper or the “Nature Medicine paper” — was published March 17, 2020, in Nature Medicine journal.
It was used by former National Institute of Allergy and Infectious Diseases Director Anthony Fauci, former National Institutes of Health Director Francis Collins, and other federal public health officials in 2020 and beyond to dismiss the possibility of a lab leak.
Biosafety Now — a nongovernmental organization that “advocates for reducing numbers of high-level biocontainment laboratories and for strengthening biosafety, biosecurity, and biorisk management for research on pathogens” — on July 19 launched the petition, stating, “It is imperative that this clearly fraudulent and clearly damaging paper be removed from the scientific literature.”
Biosafety’s leadership team includes 27 experts in biomedicine, mathematics, public health, public policy, public advocacy, law and social science.
Fraudulent paper ‘played an influential role’ in driving official narrative
Bryce Nickels, Ph.D., co-founder of Biosafety Now and professor of genetics at Rutgers University, said the petition seeks “to expose a clear case of scientific fraud and misconduct that has had a major impact on public opinion and policy.”
Nickels told The Defender :
“The removal of ‘Proximal Origins’ from the scientific literature is the first step in a long process needed to repair the damage this paper has caused to public trust in science.”
According to the petition, “This paper played an influential role — indeed, the central role — in communicating the false narrative that science established that SARS-CoV-2 entered humans through natural spillover, and not through research-related spillover.”
The petition continues:
“Email messages and direct messages via the messaging program Slack among authors of the paper obtained under FOIA [Freedom of Information Act] or by the U.S. Congress and publicly released in full in July 2023 … show, incontrovertibly, that the authors did not believe the conclusions of the paper at the time the paper was written, at the time the paper was submitted for publication, and at the time the paper was published.”
The recently-released internal communications show the paper “was, and is, the product of scientific fraud and scientific misconduct,” the petition said.
Commenting on the petition, investigative journalist Paul Thacker said:
“The thing that’s really the most troubling, which is why it should be retracted … [is] the ghostwriting and the undue influence [of federal public health officials on the drafting of the paper], which we know from the emails by Francis Collins, by Anthony Fauci, and from Jeremy Farrar.”
Thacker — who noted that within only a few days the petition had already garnered more than 1,300 signatures and set the hashtag #RetractProximalOrigins trending on Twitter — told The Defender :
“These guys basically ordered up a piece of science — or some sort of publication — that they could then point to, which they all did afterwards, as definitive proof that this thing could not have come from the lab.
“The whole thing was orchestrated for political purposes. It has nothing to do with science.”
Little more than a ‘political piece of propaganda’
Thacker is a former fellow at the Safra Center for Ethics at Harvard University whose investigative writing has appeared in The New York Times, The BMJ, the Journal of the American Medical Association and The Washington Post.
He explained that weeks prior to the paper’s publication, Kristian Andersen, Ph.D. — one of the co-authors of the “Proximal Origins” paper — emailed Fauci and Collins a draft of the manuscript, thanking them for their “advice and leadership” on the paper.
Andersen also invited Fauci and Collins to comment and offer suggestions about the paper — but neither are mentioned in the acknowledgments section of the final version published by Nature Medicine. According to Thacker:
“Both Collins and Fauci then promoted the Nature Medicine paper as evidence of ‘independent science’ pointing against a possible lab accident — Collins in a post for the NIH Director’s blog that alleged the study left ‘little room’ for argument in favor of a lab accident, and Anthony Fauci in a White House press briefing.
“In both cases, neither Collins nor Fauci disclosed their involvement in orchestrating Andersen’s study. This last March, Congress released further emails showing that Fauci helped to orchestrate the Nature Medicine paper.”
Thacker pointed out that the paper — which “has been called everything from ‘research paper’ to ‘analysis’ to ‘study’” — was “really just correspondence” that was later turned into a “political piece of propaganda that people could then reference, which they did.”
Describing the recent about-face regarding the paper’s importance, Thacker said:
“Now the editor-in-chief of Nature Medicine is saying, ‘Oh, well, it was just a viewpoint … like he’s trying to dismiss what it was when they [federal public officials] used it for completely different purposes. They used it as some definitive piece of scientific research that put to rest any idea this thing could have come from a lab.
“Then we find out internally that none of them who wrote it believed that in the first place. … Quite frankly, from the very beginning, none of the scientific evidence in any direction means anything about how this pandemic started. It’s always been the internal documents and the money that have mattered more.”
Thacker added, “This entire drama and discussion has nothing to do with science. It has everything to do with corruption and a coverup.”
On July 25 Thacker tweeted:
Writers Curtis Schube and Gary Lawkowski in a July 24 op-ed for The Hill pointed out that when the Centers for Disease Control and Prevention responded to the FOIA request to release Fauci’s “explosive” email showing his involvement with the Nature Medicine paper, the agency completely redacted the email.
Moreover, Thacker alleged that Andersen submitted false testimony at the July 11 hearing of the House Select Subcommittee on the Coronavirus Pandemic, which is investigating the origins of the COVID-19 pandemic.
Andersen’s allegation that Fauci and Collins were provided the paper only after it had been “accepted” and was in “proof” is false, Thacker said. “Emails impeach this portion of Andersen’s testimony,” he added.
Thacker also pointed out that The Intercept last week published newly revealed documents showing Andersen and his co-author — Tulane virologist Robert Garry, Ph.D. — both lied to Congress during the House hearing. The alleged lies covered the fact that both had pending federal grants controlled by Fauci — money that could have been used to influence their positions on the lab-leak theory.
Robert F. Kennedy Jr.’s latest book, “The Wuhan Cover-up: How US Health Officials Conspired with the Chinese Military to Hide the Origins of COVID-19,” is due out in September. The book is available now for preorder. Kennedy is the founder and chairman on leave from Children’s Health Defense.
Suzanne Burdick, Ph.D., is a reporter and researcher for The Defender based in Fairfield, Iowa. She holds a Ph.D. in Communication Studies from the University of Texas at Austin (2021), and a master’s degree in communication and leadership from Gonzaga University (2015). Her scholarship has been published in Health Communication. She has taught at various academic institutions in the United States and is fluent in Spanish.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Walensky Warns Public to Beware of ‘Misinformation’ and ‘Politicized Science’
By Brenda Baletti, Ph.D. | The Defender | July 5, 2023
As she ended her tenure last week as director of the Centers for Disease Control and Prevention (CDC), Dr. Rochelle Walensky warned the American public to be on guard against “misinformation” and the “politicization of science.”
Walensky told The Wall Street Journal she hopes Americans will make health decisions based on “their own risk assessment and their own personal risks, but not through politics,” emphasizing that public health recommendations also shouldn’t be politicized.
“Ironically, this comes after two-and-a-half years of Walensky misinforming the public and politicising the science,” investigative journalist Maryanne Demasi, Ph.D., wrote on her Substack.
Demasi and many others took to Twitter to remind people of Walensky’s false statements and politicized decision-making.
Walensky last week published a farewell op-ed in The New York Times, in which she wrote that public health is critically important in the U.S., and yet she “fear[s] the despair from the pandemic is fading too quickly from our memories.”
She complained that “the agency [CDC] has been sidelined, chastened by early missteps with Covid and battered by persistent scrutiny.”
She also told the WSJ that public health shouldn’t fall along partisan lines.
Yet stark political partisanship defined her time at the CDC. The WSJ reported that a recent KFF poll showed political affiliation was the strongest demographic predictor of COVID-19 vaccination. And about one-quarter of Americans don’t trust the CDC’s health recommendations, according to a 2022 survey published in the journal Health Affairs.
Walensky acknowledged “missteps in communicating” by the CDC, which, she said, “could have done a better job” making it clear to the public that the agency’s message could change during the pandemic.
But, she told the WSJ, the CDC has a plan to regain public trust in the future — by working directly with media organizations to discuss how to best shape public opinion prior to releasing scientific information to the public.
She said the CDC plans to use a method called “prebunking,” where they will communicate directly with media organizations before they release information to let the media know which details about public health might be “misconstrued.”
According to The Associated Press (AP) “prebunking” by public health agencies allows the agencies to define something as “misinformation” before readers have an opportunity to encounter it elsewhere as possibly true.
Then search engines such as Google prioritize “credible websites” like the U.S. Food and Drug Administration’s (FDA) or the CDC’s in its searches.
FDA Commissioner Robert Califf, the Virality Project and Google are among those who have promoted prebunking as a way to combat misinformation.
Journalist Kim Iversen proposed a different approach Walensky might take to restoring public trust in the CDC.
She said:
“Well, the way to do it is to apologize, to own up to your lies, to own up to the mistakes that you made and to discuss why you did that, why the agency followed such political partisanship when they should have been following science, why they ignored the science that was right in front of them.”
CDC broadcast a long list of ‘misinformation’ during Walensky’s tenure
Throughout her tenure at the CDC, which began when Biden took office in January 2021, Walensky made a series of public statements that have proven to be false.
Evidence has since emerged that Walensky knew many of these statements were false when she made them.
In March 2021, Walensky famously told Rachel Maddow, that “vaccinated people do not carry the virus, don’t get sick.”
The CDC was forced to walk back her statements a few days later. But that message was the basis for vaccine mandates imposed later that year by the Biden administration, businesses, universities and public venues throughout the country.
In a mid-June congressional hearing, Walensky defended her March statements, claiming they were true at the time.
But the Washington Examiner reported on June 20 that emails obtained through a Freedom of Information Act request showed Walensky and Dr. Francis Collins were aware of and discussed “breakthrough cases” of COVID-19 in January 2021 — just before the vaccines became widely available — and yet continued to tell the public the vaccines would prevent transmission.
In that same congressional testimony, Walensky also defended the mask mandates, saying that the summary of Cochrane’s review — which found wearing masks in the community “probably makes little to no difference” in preventing viral transmission — had been “retracted.”
But it was neither retracted nor had the authors of the review changed the language in the summary, Demasi reported.
In June 2021, Walensky told “Good Morning America” that the risk of myocarditis was extremely rare, and there was overwhelming data the vaccines were safe for children — even after hundreds of cases of myocarditis had been reported and the CDC had been aware of a safety signal since February.
Under Walensky, the CDC also gave false information on vaccine safety monitoring, added the COVID-19 vaccines to the childhood vaccine schedule despite known harms, withheld data on boosters from the agency’s own advisers and told pregnant women the vaccine was safe — just days after Pfizer reportedly finalized a report demonstrating it wasn’t.
In a March study by Krohnert and others, researchers compiled instances of errors in data presented by the CDC during the COVID-19 pandemic in publications, press releases, interviews and Twitter. The authors reported 25 instances where the agency under Walensky promoted demonstrably false numbers.
In most (80%) cases, the CDC exaggerated the severity of the pandemic. For example, Walensky gave a briefing on June 23, 2022, during which she claimed COVID-19 was a “top 5 cause of death” in children, which was untrue.
Most recently, the House Select Subcommittee on the Coronavirus Pandemic gave Walensky until July 12 to turn over phone records involving American Federation of Teachers (AFT) President Randi Weingarten. The House is investigating potential political interference on the part of AFT with the CDC’s school reopening recommendations during the COVID-19 pandemic, The Defender reported.
Walensky warns of ‘future threats’
Walensky warned at the end of her Times op-ed:
“I want to remind America: The question is not if there will be another public health threat, but when. The C.D.C. needs public and congressional support if it is going to be prepared to protect you from future threats.”
To take on these “future threats” the Biden administration nominated Dr. Mandy Cohen, an internal medicine physician and former state health secretary of North Carolina, to replace Walensky.
But critics warn Cohen is “a public health COVID authoritarian” who is “fully entrenched in the ‘bio-pharmaceutical complex.’”
Dr. Peter McCullough told The Defender that during the COVID-19 pandemic, Cohen failed to recognize therapeutics and natural immunity, and supported lockdowns, vaccine mandates and masking.
Cohen comes to the CDC from the private sector, where she is executive vice president of Aledade and CEO of Aledade Care Solutions, whose executive leadership and board of directors includes people with connections to the World Economic Forum and the Bill & Melinda Gates Foundation.
Walensky congratulated Cohen on her nomination, describing her as “a respected public health leader who helped North Carolina successfully navigate” COVID-19, and whose “unique experience and accomplished tenure in North Carolina … make her perfectly suited to lead CDC as it moves forward by building on the lessons learned from COVID-19 to create an organization poised to meet public health challenges of the future.”
Brenda Baletti Ph.D. is a reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Serious adverse events from Pfizer’s mRNA vaccine are not “rare”
Maryanne Demasi, reports | June 27, 2023
Drug regulators and public health agencies have saturated the airways with claims that serious harms following covid vaccination are “rare.”
But there has been very little scrutiny of that claim by the media, and I could not find an instance where international agencies actually quantified what they meant by the term “rare” or provided a scientific source.
The best evidence so far, has been a study published in one of vaccinology’s most prestigious journals, where independent researchers reanalysed the original trial data for the mRNA vaccines.
The authors, Fraiman et al, found that serious adverse events (SAEs) – i.e. adverse events that require hospitalisation – were elevated in the vaccine arm by an alarming rate – 1 additional SAE for every 556 people vaccinated with Pfizer’s mRNA vaccine.
According to a scale used by drug regulators, SAEs occurring at a rate of 1 in 556 is categorised as “uncommon,” but far more common than what the public has been told.
Therefore, I asked eight drug regulators and public health agencies to answer a simple question: what is the official calculated rate of SAEs believed to be caused by Pfizer’s mRNA vaccine, and what is the evidence?
The agencies were FDA, TGA, MHRA, HC, PEI, CDC, ECDC and EMA.
The outcome was startling.
Not a single agency could cite the SAE rate of Pfizer’s vaccine. Most directed me to pharmacovigilance data, which they all emphasised does not establish causation.
The Australian TGA, for example, referred me to the spontaneous reporting system but warned, “it is not possible to meaningfully use these data to calculate the true incidence of adverse events due to the limitations of spontaneous reporting systems.”
Both the German regulator (PEI) and European CDC referred me to the European Medicines Agency which, according to its own report, saw no increase at all in SAEs. “SAEs occurred at a low frequency in both vaccinated and the placebo group at 0.6%.”
The UK regulator MHRA went so far as to state it “does not make estimations of a serious adverse event (SAE) rate, or a rate for adverse reactions considered to be causally related for any medicinal product.”
The US FDA, on the other hand, did conceded that SAEs after mRNA vaccination have “indeed been higher than that of influenza vaccines,” but suggested it was justified because “the severity and impact of covid-19 on public health have been significantly higher than those of seasonal influenza.”
Despite analysing at the same dataset as Fraiman, the FDA said it “disagrees with the conclusions” of the Fraiman analysis. The agency did not give specifics on the areas of disagreement, nor did it provide its own rate of SAEs.
In response to the criticism, Joe Fraiman, emergency doctor and lead author on the reanalysis said, “To be honest, I’m not that surprised that agencies have not determined the rate of SAEs. Once these agencies approve a drug there’s no incentive for them to monitor harms.”
Fraiman said it’s hypocritical for health agencies to tell people that serious harms of the covid vaccines are rare, when they have not even determined the SAE rate themselves.
“It’s very dangerous not to be honest with the public,” said Fraiman, who recently called for the mRNA vaccines to be suspended.
“These noble lies may get people vaccinated in the short term but you’re creating decades or generations of distrust when it’s revealed that they have been misleading the public,” added Fraiman.
Dick Bijl, a physician and epidemiologist based in the Netherlands, agreed. “It goes to show how corrupted these agencies are. There is no transparency, especially since regulators are largely funded by the drug industry.”
Bijl said it’s vital to know the rate of SAEs for the vaccines. “You must be able to do a harm:benefit analysis, to allow people to give fully informed consent, especially in young people at low risk of serious covid or those who have natural immunity.”
Bijl said the mainstream media has allowed these agencies to make false claims about the safety of vaccines without interrogating the facts.
“The rise of alternative media is strongly related to the lies being told by the legacy media, which just repeats government narratives and industry marketing. In the Netherlands, there is a lot of discussion about the distrust in public messaging,” said Bijl.
From Florida’s Surgeon General, a devastating indictment of the vaccine and its pushers
By Neville Hodgkinson | TCW Defending Freedom | June 22, 2023
When it comes to error correction, the USA’s 50 sovereign states offer more opportunity for an authoritative challenge to the misuse of power than we enjoy in the UK. Dr Joseph Ladapo, the Florida Surgeon General, has made public a letter excoriating federal health officials over their promotion of the mRNA Covid vaccines. The government, he said, ‘has relentlessly forced a premature vaccine into the arms of the American people with little or no concern for the adverse ramifications’.
The letter was to Drs Robert Califf, head of the Food and Drug Administration, and Rochelle Walensky, director of the Centers for Disease Control and Prevention. Lapado wrote: ‘Your ongoing decision to ignore many of the risks associated with mRNA Covid-19 vaccines, alongside your efforts to manipulate the public into thinking they are harmless, have resulted in deep distrust in the American health care system.’
As reported here earlier this year, senior American scientists have called for a ‘bipartisan, scientifically minded Covid-19 commission so the public health disaster of the past three years is not repeated’. They face an uphill struggle in achieving that aim, but Ladapo’s no-holds-barred letter means that at least some of Florida’s 22.6million citizens have a chance of knowing the jabs are not ‘safe and effective’, as the British public are constantly being told.
Ladapo would surely have been less forthright if Ron DeSantis, Florida’s Republican governor and a possible future US president, were not also on the warpath over the Biden administration’s handling of the pandemic. The Florida Supreme Court has approved DeSantis’s request to convene a grand jury to investigate ‘wrongdoings’ associated with the vaccines.
But DeSantis is not alone. The Texas Attorney General has launched an investigation into whether Pfizer, Moderna and Johnson & Johnson, the companies producing the jabs, misrepresented their safety and efficacy and manipulated trial data. The investigation could open the door to lawsuits by people injured by the mRNA products.
Meanwhile, what hope of redress do Britons have, not just for vaccine damage but for the lives shattered by cruel and unprecedented lockdowns?
The public inquiry led by Baroness Hallett looks likely to be worse than useless, as Laura Dodsworth, author of the best-selling A State of Fear: How the UK Government Weaponised Fear During the Covid-19 Pandemic, has described.
It is in ‘the wise and noble tradition of the great British public inquiry’, Rod Liddle commented in the Sunday Times last weekend. That is, keep the public away from it for as long as possible, and say nothing useful or meaningful unless ‘at least 20 years after whatever it is that they are inquiring about, at which point most of the relevant people are stiff as a stoat’.
The headline on Liddle’s article declared: ‘The data is clear: lockdowns are useless. But you won’t hear that from the inquiry.’
Sadly, neither the Sunday Times nor its daily stablemate, nor just about any of the mainstream media in the UK, have yet ventured into questioning the ‘safe and effective’ narrative about the vaccines. So let’s look at what Ladapo, who as state surgeon general can hardly be dismissed as a conspiracy theorist, has told the American public.
‘Data are unequivocal,’ Ladapo wrote. ‘After the Covid-19 vaccine rollout, the Vaccine Adverse Events Reporting System (VAERS) reporting increased by 1,700 per cent, including a 4,400 per cent increase in life-threatening conditions.
‘Dismissing this pronounced increase as being solely due to reporting trends is a callous denial of corroborating scientific evidence also pointing to increased risk and a poor safety profile. It also fails to explain the disproportionate increase in life-threatening adverse events for the mRNA vaccines compared to all adverse events.
‘Based on the CDC’s own data, rates of incapacitation after mRNA vaccination far surpass other vaccines.’
Ladapo cited a recent study which found an excess risk of serious adverse events ‘of special interest’ for 1 in 550 people after mRNA vaccination. He wrote: ‘As you are aware, this is extraordinarily high for a vaccine. In comparison, the risk of serious adverse events after influenza vaccination is much lower. For you to claim that serious adverse events such as these are “rare” when Pfizer and Moderna’s clinical trial data indicate they are not, is a startling exercise in disinformation.
‘I want to re-emphasise that these questions could have been answered if you had required vaccine manufacturers to perform and report adequate clinical trials . . . I anticipate with regret that you will repeat past mistakes and prematurely promote new therapies to Americans without accurately and truthfully weighing data on risks and benefits.’
Ladapo then asked Califf and Walensky to answer 12 questions relating to the safety data, and concluded: ‘Your organisations are the main entities promoting vaccine hesitancy – Florida promotes the truth. It is our duty to provide all information within our power to individuals so they can make their own informed health care decisions. A lack of transparency only harms Americans’ faith in science.’
Regular readers of TCW as well as The Daily Sceptic know that numerous scientists support Ladapo’s position, such as reported here, here, here, here, here, here and here.
At present, however, the FDA and CDC, like the NHS, continue to ignore such reports, asserting that ‘the known and potential benefits of these vaccines clearly outweigh their known and potential risks, and that ‘being up to date on vaccinations saves lives compared with individuals who did not get vaccinated’.
What’s Wrong With This Study? CDC Finds COVID Shots ‘Safe and Effective’ for Kids Under 4
By Angelo DePalma, Ph.D. | The Defender | June 16, 2023
An analysis published earlier this month in Pediatrics concluded the COVID-19 mRNA vaccines are safe and effective in preschool-age children — a conclusion trumpeted by media outlets such as Parents and Medscape.
But the study, conducted by Kaiser Permanente researchers with funding from the Centers for Disease Control and Prevention (CDC), raises more questions than it answers.
Researchers followed children (mostly 4 years old or younger) who collectively received more than 245,000 doses of either the Pfizer or Moderna mRNA products and “found no indications of serious side effects,” according to a Kaiser Permanente news release.
Using a form of surveillance monitoring known as rapid cycle analysis, investigators performed weekly sequential analyses for 19 safety signals, including myocarditis, pericarditis, seizures, heart attack, Bell’s palsy, neurological inflammatory conditions, anaphylaxis and several others.
The study period was from June 2022 to March 2023.
Instead of using a comparable group of unvaccinated children as the control, the authors compared adverse events occurring 1-21 days after vaccination in one group, with outcomes among children in another group who had received the shot at some point between 22 and 42 days previously.
Time since inoculation was the only distinguishing feature, and the only factor that might account for inter-group differences.
The study, therefore, boils down to the question of whether children who received an mRNA shot about 10 days previously experienced more or fewer adverse events than children who received their jab about 32 days previously.
Data were mined from the Vaccine Safety Datalink (VSD), a repository of patient data from eight private healthcare systems, which included five Kaiser Permanente regions and three other large health entities.
Up to three doses of the Pfizer-BioNTech product were given to 135,000 children, ages 6 months to 5 years, while 112,000 children, ages 6 months to 6 years, got the Moderna gene therapy.
Subject demographics more or less reflected the populations served by these healthcare companies.
The authors wrote that their safety surveillance over nine months “did not detect a safety signal for any outcome during the 21 days after vaccination. Importantly, no cases of myocarditis or pericarditis occurred after vaccination.”
The accompanying press release framed the conclusion even more positively. According to corresponding author Dr. Nicola Klein:
“Parents can be assured that this large study found no serious side effects from the mRNA vaccines. … Parents can protect their young children from COVID-19 in the same way they vaccinate their children to protect from other serious childhood diseases.”
Perhaps anticipating the long list of questions regarding their work, the researchers discussed the potential limitations of their analysis, which they said included:
- Reduced statistical power, particularly for rare outcomes.
- Low vaccine uptake in the evaluated age group (“only” 24.7% of the eligible population received at least one shot).
- Surveillance did not include “all potential safety concerns.”
And the kicker:
“We may have underestimated or missed potential safety concerns if the biologically plausible risk interval for an outcome differed from our specified risk interval.”
Together, the choice of control group and the time period selected almost guaranteed “reduced statistical power,” particularly when comparing the two groups.
In a 2022 paper Klein noted reports from “worldwide” sources of myocarditis/pericarditis after mRNA COVID-19 treatments “especially among younger male persons [italics mine] 0 to 7 days after receiving dose 2.”
Although the incidence of heart inflammation was low in the 0-5 age group for the Pfizer product (14.4 per million doses, mostly after the second shot), the incidence of serious cardiac events rose markedly for older groups.
No data were available in the 2022 study for the Moderna shot.
For 18- to 29-year-old males — the youngest age group for which both Pfizer and Moderna data were available — Klein reported, based on VSD numbers, a cumulative myocarditis/pericarditis incidence of 135 cases per million for children who had received the two injections plus the booster.
For the Moderna product, the incidence was 185 per million. For females, the rates were about 10 per million for both mRNA shots.
Given the serious long-term consequences of heart inflammation, and its known occurrence among vaccinated teenagers and young adults, one wonders at the wisdom of giving mRNA shots to children who are even younger than those known to get sick from the treatments.
COVID-19 itself has been blamed for the rise in heart inflammation, but a search for data from very early in the pandemic, before this storyline emerged (possibly to hide the incidence of “vaccine” injuries), shows this to be a red herring.
A 2022 Italian study comparing myocarditis/pericarditis incidence pre- and post-COVID-19 reported that the annual incidence of myocarditis was significantly higher before the pandemic than during, with a rate of about 80 per million “pre” and 60 per million “during.”
The authors made a point to emphasize that “the incidence of myocarditis was significantly lower in COVID than in PRECOVID in the class of age 18-24 years” than for their general study population, which averaged 40 years of age.
The incidence of pericarditis was unchanged between the two time periods, at about 45 per million.
Comparing data from two far-flung studies should be undertaken with caution. However, the difference between a baseline of fewer than 60 cases per million for 18- to 24-year-old adults (the Italian study) and the 185 per million for “male persons” between 18 and 29 post-mRNA treatment (Klein et al.) clearly and inconveniently shatters the “safe and effective” narrative.
The lack of statistical power in Klein’s 2023 study, despite a very large “denominator” (total patients studied), is almost certainly due to the relatively small number of cases — which is exactly what one would expect when uncommon (but serious) side effects over such short time periods are compared.
True, this is an apples-to-apples comparison — but in this case, investigators pretty much used the exact same apples and reported their similarities as somehow noteworthy.
Klein’s data source(s) raise additional questions. Although the VSD is connected to the national Vaccine Adverse Event Reporting System (VAERS), how much of her raw data came from VAERS and how much came from VSD is unclear.
Eleven of VSD’s 13 participating commercial and academic hubs are “data reporting sites” whose contributions presumably include vaccine side effect reports.
The concern here is about motives and incentives. VAERS data are based mainly on self-reporting and are known to be gross underestimates of the actual number of incidents.
By contrast, hospitals and healthcare systems, e.g. those participating in VSD, were robustly incentivized to promote and administer the COVID-19 shots.
Along those lines, note that one author “received funding from Janssen Vaccines and Prevention for a study unrelated to coronavirus disease 2019 vaccines.” And lead investigator Klein “received grants from Pfizer for coronavirus disease 2019 vaccine clinical trials and from Merck, GSK, and Sanofi Pasteur for study work unrelated to the current study work.”
The rationale for immunizing children against COVID-19 has been hotly debated since the shots were first available to older adults in late 2020.
But by the time these treatments were authorized for children, it was already clear that kids do not get very sick from COVID-19 and are not a significant source of infection, either for the community or for “grandma” in her rocking chair at home.
As of early 2021, with the huge wave of Delta-variant fatalities in freefall, the number of U.S. pediatric COVID-19 deaths reported by the CDC was close to zero, both in terms of absolute cases and as a percentage of all deaths.
Yet in her interview with her institution’s media department, lead author Klein said:
“Even as the COVID-19 emergency has ended, we know that the coronavirus poses a long-term, serious threat to all ages, including children. Vaccinating children against COVID-19 benefits them by reducing the burden of illness, avoiding spreading the virus to family and others, and mitigating the small but real risk of serious illness.”
Angelo DePalma, Ph.D., is a contributing editor for The Defender.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
‘Reckless in the Extreme’: FDA Panel Recommends New RSV Shot for Use in Healthy Infants
By Michael Nevradakis, Ph.D. | The Defender | June 9, 2023
Advisors to the U.S. Food and Drug Administration (FDA) on Thursday recommended approval of AstraZeneca’s new monoclonal antibody, which the drugmaker said is designed to protect infants and toddlers up to age 2 from respiratory syncytial virus (RSV).
The drug, nirsevimab, would be delivered to newborns in a single shot at birth or “just before the start of a baby’s first RSV season, or as a larger dose in a second RSV season in children who are highly vulnerable,” CNN reported.
Members of the independent committee, which includes several pediatricians, “were enthusiastic about the potential” of the antibody, STAT reported, as was Thomas Triomphe, executive vice president of vaccines at Sanofi, which will market the drug in the U.S.
In a statement, Triomphe said:
“Most babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact.
“We are encouraged by the advisory committee’s positive vote based on the compelling clinical development program supporting nirsevimab and its breakthrough potential to reduce the magnitude of annual RSV burden.”
But medical experts interviewed by The Defender raised a number of concerns, including what they said was inadequate safety testing.
“It’s preposterous to give this drug prophylactically, especially without adequate safety testing,” said Brian Hooker, Ph.D., P.E., senior director of science and research for Children’s Health Defense (CHD).
AstraZeneca reported only 48% efficacy for the drug. And Hooker noted that the “circulating half-life of the antibodies is probably less than one month so the protection would be minimal at best.”
Hooker also commented on the fact that 12 infant deaths were recorded during the clinical trial, which the FDA committee claimed were “unrelated” to the antibody:
“It appears that this vote was meant to bolster uptake and popularity of the RSV vaccines that are now approved for maternal use. The very low rate of effectiveness for such a therapy is troubling as the conservative estimate is below 50%, which is usually a hard metric for drug approval.
“Also, it seems odd that four infants in the trial would die of cardiac arrest — with no information given, it leaves one to wonder why these children would die in such a way. Also, there should be further investigation into the two SIDS [sudden infant death syndrome] deaths that occurred during the trial.”
Dr. Meryl Nass, an internist, biological warfare epidemiologist and member of CHD’s scientific advisory committee, told The Defender,“It is reckless in the extreme to inject very young babies with an inadequately tested monoclonal antibody drug to prevent a condition that for most of them will be no more than a cold.”
Cardiologist Dr. Peter McCullough told The Defender that while monoclonal antibodies are “generally safe” for children, he questioned the benefit of such a treatment for what he called a “mild” infection. He said:
“Monoclonal antibodies are generally safe in children and adults; however, I am concerned broad infant population uptake may disrupt normal thymus and immune system development that easily handle infections such as RSV, influenza, rhinovirus, adenovirus and SARS-CoV-2.
“RSV is a characteristically mild infantile infection easily resolved with conventional nebulizers. I believe nirsevimab would not be clinical-indicated for all infants and likely would be utilized in high-risk babies with congenital heart or lung disease, such as cystic fibrosis, or those with prior thoracotomies for heart surgery, where respiratory mechanics would be compromised.”
The FDA committee’s positive recommendation for nirsevimab, also known as Beyfortus, comes just weeks after the agency approved GlaxoSmithKline Biologicals’ Arexvy, the first-ever RSV vaccine for older adults, and recommended Abrysvo, Pfizer’s RSV vaccine for pregnant women.
According to CNBC, the FDA is expected to make a final decision on nirsevimab in the third quarter of this year.
Nass told The Defender that while the FDA is not obligated to follow the panel’s advice, “it almost always does so.”
FDA: Infant deaths during clinical trial ‘unrelated’ to the treatment
CNBC reported that the FDA review identified no safety concerns with nirsevimab, but also reported that 12 infants died during the trials.
According to CNBC:
“Four died from cardiac disease, two died from gastroenteritis, two died from unknown causes but were likely cases [of] sudden infant death syndrome, one died from a tumor, one died from COVID, one died from a skull fracture, and one died of pneumonia.”
Dr. Melissa Baylor, who according to CNBC is “an FDA official,” said, “Most deaths were due to an underlying disease. None of the deaths appeared to be related to nirsevimab.”
But according to STAT, “There are questions that remain to be answered” about nirsevimab that require “further study.”
For instance, no data are available “about whether giving nirsevimab to a baby whose mother was vaccinated against RSV during pregnancy would give the infant more protection or would be a waste of the product.”
STAT noted that several members of the FDA committee “worried that the dose given in the first year of life might be too small to benefit a baby who was 8 months or older when receiving the injection, depending on the size of the baby.”
Baylor also expressed concerns about how nirsevimab would interact with vaccines in development — such as Pfizer’s Abrysvo — that confer protective antibodies to the fetus by administering the shot to the mother.
CNBC reported that “Other monoclonal antibodies have been associated with serious allergic reactions, skin rashes and other hypersensitivity reactions.”
According to Baylor, the FDA did not identify “any cases of serious allergic reactions in the nirsevimab trials,” while “cases of skin rash and hypersensitivity reactions were low in infants who received the antibody.” She added that cases of such side effects are expected to be observed if the treatment receives FDA approval.
Manish Shroff, AstraZeneca’s head of patient safety, said, “Safety is of utmost importance” to the drugmaker and that it will “keep a close eye” on the safety of nirsevimab via a “global monitoring system,” CNBC reported.
According to Endpoints News, nirsevimab has already received regulatory approval in the EU, U.K. and Canada, but “it has not yet launched in any of those markets.”
According to CNBC, “Nirsevimab is administered as a single injection with the dose depending on the infant’s weight.”
Infants weighing less than 5 kilograms will receive a 50 mg dose for their first RSV season, while those over 5 kilograms will receive a 100 mg injection. Children under age 2 who “remain at risk for severe RSV” in their second season would then receive an additional 200 mg injection of the antibody.
Nirsevimab is not the first monoclonal antibody for RSV. According to STAT, AstraZeneca’s Synagis (palivizumab) is approved in the U.S. and EU, and “protects against infection in high-risk infants.”
According to CNBC, it is intended “only for preterm infants and those with lung and congenital heart conditions that are [at] high risk of severe disease” and is administered monthly, whereas nirsevimab “would be administered to healthy infants.”
Endpoints News reported that “AstraZeneca leads all development and manufacturing activities” for nirsevimab, “while Sanofi is responsible for marketing activities and revenue recognition” — for which the drugmaker paid $129 million “to be part of the collaboration.”
Is RSV really a danger for most infants?
CNBC previously reported that the U.S. “suffered an unusually severe RSV season” this past winter. The New York Times reported on a “tripledemic” involving RSV, flu and COVID-19, “that swamped children’s hospitals and some I.C.U. wards.”
One U.S. county — Orange County, California — declared a local health emergency and issued a proclamation of local emergency in November 2022, citing rising RSV cases among children in the region, and the Biden administration subsequently declared a public health emergency that month.
According to the U.S. Centers for Disease Control and Prevention (CDC), nearly all children are infected with RSV before the age of 2.
While CNBC characterized RSV as a “public health threat” that “kills nearly 100 babies in the United States every year,” Nass questioned the danger it poses to most infants.
In May, Nass wrote that the CDC published a paper on RSV deaths in infants between 2009 and 2021, which found “were only a total of 300 deaths in children less than one year over the 12 years, or 25 on average per year.”
Nass added that the number of injuries that may be caused by vaccines or other treatments during pregnancy “is almost certainly going to outweigh the loss of 25 babies a year from RSV.”
In her remarks to The Defender, Nass drew comparisons with the hepatitis B vaccine for children, saying that adverse effects from the treatment may appear later in childhood and are not likely to be connected to the drug:
“The hepatitis B vaccine, recommended for all children at birth in the US, and received by about 75%, was never tested for babies’ safety — over more than a few days — before the program started, or since.
“Because no one can know what a very young baby will become at birth, it is impossible to attribute a lower IQ, hyperactivity, less nimble limbs or any other problem that shows up later, to an injected drug given shortly after birth. So those connections, if any, are unlikely to be identified.”
Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
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The Old Testament and the Genocide in Gaza
“You will chase your enemies, and they shall fall by the sword before you. Five of you shall chase a hundred, and a hundred of you shall put ten thousand to flight; your enemies shall fall by the sword before you.”
Leviticus, Chapter 26, verses 7-9“When the Lord your God brings you into the land you are entering to possess and drives out before you many nations… then you must destroy them totally. Make no treaty with them and show them no mercy.”
Deuteronomy 7:1-2,“…do not leave alive anything that breathes. Completely destroy them… as the Lord your God has commanded you…”
Deuteronomy 20:16Gilad Atzmon | January 8, 2009
There is not much doubt amongst Biblical scholars that the Hebrew Bible contains some highly charged non-ethical suggestions, some of which are no less than a call for a genocide. Biblical scholar Raymund Schwager has found in the Old Testament 600 passages of explicit violence, 1000 descriptive verses of God’s own violent actions of punishment, 100 passages where God expressly commands others to kill people. Apparently, violence is the most often mentioned activity in the Hebrew Bible.
As devastating as it may be, the Hebrew Bible saturation with violence and extermination of others may throw some light over the horrifying genocide conducted momentarily in Gaza by the Jewish state. … continue
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