TGA hides from questions about sudden infant deaths after vaccination
By Maryanne Demasi, PhD | October 28, 2024
Sudden unexpected death in infancy (SUDI) and sudden infant death syndrome (SIDS) are names for the sudden and unexpected death of a baby when there is no apparent cause of death.
The Therapeutic Goods Administration (TGA) has gone to ground after being confronted with questions about a series of sudden deaths in infants who received the Infanrix-Hexa® vaccine.
The “hexavalent” vaccine protects against six diseases (diphtheria, tetanus, whooping cough, polio, hepatitis B and Hib) and is administered to infants at 2, 4 and 6 months of age.
Approved by the TGA in 2006, the vaccine lies at the heart of the National Immunisation Program, and has been administered to millions of babies across the country [Australia].
FOI request
A freedom of information (FOI) request for the number of deaths reported after use of the Infanrix-Hexa® vaccine has revealed some worrying data.
The Database of Adverse Event Notifications (DAEN) shows 17 reported deaths in infants.
A further 26 reported deaths exist in the TGA’s ‘internal’ database, the Adverse Event Management System (AEMS), according to a recent FOI report.
Overall, 43 sudden unexpected deaths have been reported in babies mostly under 12 months of age, which have occurred within a day or two of vaccination.
Now, after many weeks of enquiries, the TGA has gone into hiding and refuses to confirm whether it has made any attempt to investigate the deaths.
Warnings from Europe
Infanrix-Hexa® was first authorised by the European Medicines Agency (EMA) in 2000, and the public has never been alerted to any safety issues.
EMA says it monitors pharmacovigilance data in the form of Periodic Safety Update Reports (PSURs), which are submitted by the manufacturer, GlaxoSmithKline (GSK).
Essentially, PSURs describe the worldwide safety experience of the vaccine over a defined period, and are not usually available to the public for independent scrutiny.
However, a major lawsuit in Italy involving GSK, resulted in the Judge ordering the drug company to publicly release its PSURs for the Infanrix Hexa® vaccine.
Those documents were sent to Jacob Puliyel, a paediatrician and Head of the Department of Paediatrics, St Stephen’s Hospital, Delhi, who carried out an independent review.
The analysis revealed a cluster of sudden deaths among infants less than 12 months of age — 54 deaths (93%) occurred within the first 10 days of vaccination, and 4 deaths (7%) occurred within the next 10 days of vaccination.
Further, when he compared the rate of ‘expected’ sudden deaths, to the ‘actual’ rate of sudden deaths post-vaccination, there was a statistically significant increased risk of death in the first four days after vaccination, compared to the expected deaths.
The report concluded, “The clustering of deaths soon after immunisation suggests that the deaths were caused by the vaccine.”
Puliyel published the findings in the Indian Journal of Medical Ethics in 2018.
The report also showed that infant deaths, which were reported in the safety report (PSUR 16) were deleted in the PSUR 19, effectively underreporting the number of observed deaths in the final report seen by EMA.
I contacted Puliyel to ask why EMA had not raised the alarm regarding the PSUR data, and he said he thought the data were misleadingly presented to EMA.
“I wouldn’t go as far as saying that EMA colluded with GSK in the subterfuge, but I think EMA was negligent and accepted the manufacturers’ deceptive data and interpretations unquestioningly,” he said.
Puliyel criticised EMA for its lax monitoring of post-marketing adverse events and has been urging all regulators to do better.
After the publication of his findings, Puliyel said there was no excuse for EMA to ignore the data discrepancies.
“The silence suggests EMA has no defence,” he remarked.
“I think nowadays, surveillance methods are designed to protect vaccine company profits rather than the public,” he added.
When I contacted EMA, the agency denied that deaths were “deleted” from the report as Puliyel claims.
Instead, EMA said the deaths were “reclassified” after it was determined the babies died of underlying diseases, such as “viral meningitis, an inborn error of metabolism congenital hydrocephalus and congenital heart disease.”
Puliyel rejected EMA’s explanation, calling it “singularly unconvincing.”
“Viral meningitis, congenital hydrocephalus and congenital heart disease would have been obvious at the time of vaccination when the children died – not discovered many years later,” explained Puliyel.
“EMA has to explain why these obvious underlying causes were not considered causes of death when the 16thPSUR report was published and why it had to be ‘reclassified’ years later,” remarked Puliyel.
‘When the number of sudden deaths exceeded deaths expected as per the calculations in the 19th PSUR – there was this urge to ‘reclassify’ three sudden unexplained deaths as ‘deaths due to underlying causes,’” he said.
TGA enquiries continue
Efforts to compel a response from the TGA will continue, but the latest data on Infanrix-Hexa® have raised broader questions about the safety of the newer generation of vaccines designed to protect against multiple diseases within a single shot.
I will explore this in a forthcoming investigation.
Idaho Health Board First in U.S. to Defy CDC and FDA by Removing COVID Vaccines From Clinics
By Suzanne Burdick, Ph.D. | The Defender | October 29, 2024
Idaho’s Southwest District Health will no longer offer COVID-19 vaccines after its board voted 4-3 last week to pull the shots from the 30 locations where it provides healthcare services.
“It’s the first health agency in America to do that,” Laura Demaray, a Southwest Idaho resident and nurse who attended the Oct. 22 vote, told The Defender.
Miste Karlfeldt, executive director of Health Freedom Idaho, agreed that the board’s vote is historic. “It’s thrilling,” she told The Defender.
The board’s vote came after it received about 300 public comments urging the district, which encompasses six counties, to stop promoting the shots.
Just before the board voted, members heard presentations from cardiologist Dr. Peter McCullough, pathologist Dr. Ryan Cole, pediatrician Dr. Renata Moon and obstetrician and gynecologist Dr. James Thorp on safety concerns related to the COVID-19 vaccines.
Dr. John Tribble, the board’s only physician, invited them to speak.
“Dr. Tribble was a very brave board member who is very aware of the harms of the COVID injection,” said Demaray. “He asked me to help gather the presenters.”
Demaray, who said she knows many people injured by the COVID-19 vaccines, and others reached out to experts who could present data related to COVID-19 vaccine harms to the board. “It was total teamwork.”
Mary Holland, Children’s Health Defense CEO, applauded the board’s action:
“After hearing from 300 constituents, listening to well-informed physicians and assessing the public record, the Southwest Idaho Health District Board made an informed decision not to stock its own clinics with COVID shots.”
Demaray and Holland pointed out that the board didn’t take away anyone’s freedom to get a COVID-19 vaccine. “If residents want, they can obtain the shots from other pharmacies and doctors’ offices,” Holland said.
Demaray said the board’s decision showed “there’s some distrust in this shot.” She added:
“If a health district is giving a shot in their own clinics, then it means they believe in the shot and they don’t think somebody will get hurt. It means they support it tacitly.”
Holland said, “The Health District Board was conveying its values to the public — ‘these products are unsafe and we do not promote them’ — and the board was within its authority to do this.”
A precedent for other health agencies?
Tribble told The Defender some of the backstory leading up to the historic vote. “The people of this district were demanding answers,” he said. “Many came forward with heartbreaking stories of vaccine injury.”
After listening to its residents, the board members felt it was important to allow “the free and open discussion and evaluation of the evidence for and against the safety and efficacy of the COVID-19 vaccine.”
In addition to hearing presentations from McCullough, Moon, Cole and Thorp, the board also heard from district staff physician Dr. Perry Jansen who recommended keeping the vaccine on the district’s clinic shelves.
“In the end,” Tribble said, “the evidence clearly showed a lack of safety and efficacy as it compares to the risk from COVID-19 and their [the board members’] decision reflected that.”
The board members who voted to remove the shot “exhibited courage” because they did so “based on the evidence, in direct opposition to the federal health agencies’ recommendations.” Tribble said:
“I believe our actions here stand as an example and precedent for other health agencies to take back control of their health and freedoms from a corrupted federal system. I hope this will inspire other health agencies to openly discuss this issue and evaluate the evidence for themselves.”
‘That is how you open up a can of truth’
Karlfeldt said she’s confident the board’s landmark decision will embolden other health administrators across Idaho and the rest of the U.S. to make similar moves.
Demaray agreed. She said she already heard from two other Idaho health districts that are now considering pulling the COVID-19 shots from their clinics after learning of the Southwest District’s vote.
Demaray encouraged other U.S. citizens to reach out to their local health board members, asking them to review the safety information on the COVID-19 vaccines.
Many federal health agency leaders are captured by industry, but that’s not the case with most local-level health officials, Demaray said. “They aren’t all bought out yet.”
“If you bring your local doctors like Dr. Tribble — or Dr. Cole, Dr. McCullough, Dr. Moon and Dr. Thorp — if you bring them and they make presentations, it is public record and your community gets to see that,” she said.
“That is how you open up a can of truth,” Demaray added.
There’s a lot of power at the local level because while the Centers for Disease Control and Prevention (CDC) recommends COVID-19 vaccines and the U.S. Food and Drug Administration (FDA) approves them, it’s typically the local agencies that adopt policies to promote them.
Holland said, “Sadly, people need to accept that they cannot trust the federal government anymore when it comes to their health.”
VAERS: 1.6 million reports of injury or death after COVID vaccination
Nicolas Hulscher, an epidemiologist at the McCullough Foundation, commended the board for its action.
“Southwest Idaho Health District has made the correct and brave choice to remove COVID-19 injections from their clinics,” Hulscher said. “The updated boosters were never tested in humans, while previous iterations have demonstrated that they’re not safe for human use.”
Hulscher noted that Boise State Public Radio’s coverage of the vote labeled the presentations by McCullough and others as “anti-vaccine.”
The Boise State Public Radio article — which referred to McCullough and the other presenters as “doctors widely accused of spreading conspiracy theories and misinformation” — appeared to “blindly favor COVID-19 vaccines,” he said, “while ignoring deeply worrisome safety data.”
For instance, the number of injuries and deaths reported to the Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccination continues to climb.
VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before confirming the reported adverse event was caused by the vaccine. VAERS has historically been shown to report only 1% of actual vaccine adverse events.
As of Sept. 27, there were 1,604,710 VAERS reports of injury or death following a COVID-19 vaccination.
The board’s vote has helped create greater public awareness that the COVID-19 shots “are massively injurious gene therapy products,” Holland said.
Tribble agreed:
“People need to understand that these shots are not vaccines by the traditional definition. That is to say, they do not impart immunity or prevent transmission.
“They were rushed to market, given legal immunity and coercively pushed upon the world’s population backed by unfounded fears spread by governments and media.”
Moreover, the safety and efficacy data we have is limited and primarily released by the same vaccine companies that stood to make hundreds of billions of dollars off of these injections, Tribble added.
“This experiment with mRNA gene therapy during COVID-19 will be shown to be one of the most egregious examples of democide in world history,” he said.
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.
Despite Concerns About ‘Vaccine Fatigue,’ CDC Recommends Extra COVID Boosters, Including for Some Infants
By Brenda Baletti, Ph.D. | The Defender | October 24, 2024
Advisers to the Centers for Disease Control and Prevention (CDC) on Wednesday recommended two COVID-19 boosters during the 2024-2025 season for people ages 65 and older and for younger people who are moderately or severely immunocompromised.
The Advisory Committee on Immunization Practices (ACIP) also recommended that immunocompromised people ages 6 months and older take “additional doses” of the shot — three or more — based on shared clinical decision-making between doctor and patient.
The vote for all three new COVID-19 vaccine recommendations was unanimous.
The committee also voted 14-1 to recommend Pfizer and Merck’s pneumococcal conjugate vaccines — designed to protect against meningitis and pneumonia — for all adults who have never received the vaccine ages 50 and older, lowering the recommended age from 65.
The U.S. Food and Drug Administration in June approved Merck’s Capvaxive for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.
The vote expands the market for both companies, who will now be able to market their vaccines to millions more eligible adults, boosting their annual revenues by hundreds of millions of dollars, FiercePharma reported.
CDC Director Mandy Cohen endorsed the recommendations after the meeting, making them official CDC recommendations.
“CDC will continue to educate the public on how and when to get their updated vaccinations so they can risk less severe illness and do more of what they love,” Cohen said.
“ACIP loves advising that people receive the most vaccines possible,” internist Dr. Meryl Nass told The Defender.
She added:
“When ACIP talks about shared decision-making, what they mean is this: ‘We lack the data to recommend this vaccine for this group, so we could be criticized (or worse) for making an unscientific recommendation. But we really want you to have it.’
“So we think the patient and doctor (who is much less educated about the minutiae regarding the vaccine than the ACIP members are) should together decide whether the patient should get it. That way we protect ourselves while maximizing the number of jabs.’”
Nass said that if ACIP members were serious about shared clinical decision-making, “They would put all their thoughts down so clinicians could become educated and then jointly evaluate the risks and benefits with patients.”
The committee also voted unanimously to add high-dose and adjuvanted flu vaccines to the Vaccines for Children Program — which provides free vaccines to children whose families can’t afford them — for transplant recipients taking immunosuppressive medications.
ACIP is described as an independent, nonfederal expert body of professionals with clinical, scientific and public health expertise. The committee decides which vaccines should be recommended to the public, who should take them and how often.
In practice, most members have financial ties to vaccine makers that they don’t consider to be conflicts of interest. For example, in Wednesday’s meeting, paid Merck consultant and researcher Noel Brewer, Ph.D., declared “no conflict” before voting to recommend Merck’s vaccine.
More recommendations may ‘exacerbate existing vaccine fatigue’
The CDC said that in the 2023-2024 COVID-19 season, only 8.9% of people over age 65 and 5.4% of immunocompromised adults age 18 and older had received two boosters.
The presenter, Dr. Georgina Peacock, said there was “obviously a need for additional education and recommendations,” but raised concerns that additional recommendations “may also exacerbate existing vaccine fatigue.”
Ruth Link-Gelles, Ph.D., presented COVID-19 vaccine efficacy data that provided the rationale for the new recommendations. Efficacy is affected by time since the last booster dose, changes in COVID-19 variants and the time since someone was last infected with COVID-19, she said.
Link-Gelles said those are hard to disentangle, especially given that all adults have high rates of infection-induced immunity. Infection-induced immunity rates ranged from 72% for people over age 65 to 89% for those ages 16-49 and 84% for those ages 50-64.
In adults over 65, she said protection waned to zero against emergency room visits and hospitalization by four to six months and was somewhat more effective against critical illness.
She also said that additional education alone wasn’t effective in increasing uptake.
Waning efficacy: an argument for more shots or proof of natural immunity?
Link-Gelles presented a slide that showed COVID-19 vaccine effectiveness waned significantly among people ages 18-64, beginning at 30% and dropping to negative 15% by six months post-vaccination.
When pressed on how to interpret the negative efficacy, she said, “There is no biological plausibility for the vaccine increasing your risk of disease.”
Vaccine effectiveness data is relative, meaning it’s a measure of how much more protection a vaccinated person has than an unvaccinated one, she said. Therefore, “what we think is happening” is that unvaccinated people were getting natural immunity during that time, giving them more robust immunity and skewing the baseline for comparison.
Because vaccine efficacy is a comparison of the disease in the vaccinated versus the unvaccinated, if the efficacy is negative, “then the unvaccinated have more protection than the vaccinated,” Karl Jablonowski, Ph.D., senior research scientist at Children’s Health Defense, told The Defender.
Jablonowski pointed out that Link-Gelles suggested the unvaccinated are exposed to wild-type COVID-19 and then gain immunity, compared with the vaccinated who would not gain that same wild-type immunity.
“What Dr. Link-Gelles is not entertaining, that which she sees ‘no biological plausibility,’ is the possibility of diminishing immune health of the vaccinated,” he said.
Jablonowski added:
“Both scenarios reduce the infections in the unvaccinated relative to the vaccinated. Either scenario points to the same conclusion, that the unvaccinated have superior long-term (180-299 days) immune health when facing the COVID-19 pandemic.
“More broadly, you cannot present VE [vaccine efficacy] analysis as a valid assessment of how well a vaccine works and then disregard the analysis when it shows the vaccine is not working.
“It is clear, from CDC’s own data and presentation, that the vaccinated had a higher long-term incidence of disease than the unvaccinated.”
Watch the Oct. 23 ACIP meeting here
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.
The Most Devastating Report So Far
By Jay BhattacharyaJayanta Bhattacharya | Brownstone Institute | October 27, 2024
The House report on HHS Covid propaganda is devastating. The Biden administration spent almost $1 billion to push falsehoods about Covid vaccines, boosters, and masks on the American people. If a pharma company had run the campaign, it would have been fined out of existence.
HHS engaged a PR firm, the Fors Marsh Group (FMG), for the propaganda campaign. The main goal was to increase Covid vax uptake. The strategy: 1. Exaggerate Covid mortality risk 2. Downplay the fact that there was no good evidence that the Covid vax stops transmission.
The propaganda campaign extended beyond vax uptake and included exaggerating mask efficacy and pushing for social distancing and school closures.
Ultimately, since the messaging did not match reality, the campaign collapsed public trust in public health.
The PR firm (FMG) drew most of its faulty science from the CDC’s “guidance,” which ignored the FDA’s findings on the vaccine’s limitations, as well as scientific findings from other countries that contradicted CDC groupthink.
The report details the CDC’s mask flip-flopping through the years. It’s especially infuriating to recall the CDC’s weird, anti-scientific, anti-human focus on masking toddlers with cloth masks into 2022.
President Biden’s Covid advisor Ashish K. Jha waited until Dec. 2022 (right after leaving government service) to tell the country that “[t]here is no study in the world that shows that masks work that well.” What took him so long?
In 2021, former CDC director, Rochelle Walensky rewrote CDC guidance on social distancing at the behest of the national teachers’ union, guaranteeing that schools would remain closed to in-person learning for many months.
During this period, the PR firm FMG put out ads telling parents that schools would close unless kids masked up, stayed away from friends, and got Covid-vaccinated.
In March 2021, even as the CDC told the American people that the vaxxed did not need to mask, the PR firm ran ads saying that masks were still needed, even for the vaxxed. “It’s not time to ease up” we were told, in the absence of evidence any of that did any good.
In 2021, to support the Biden/Harris administration’s push for vax mandates, the PR firm pushed the false idea that the vax stopped Covid transmission. When people started getting “breakthrough” infections, public trust in public health collapsed.
Later, when the FDA approved the vax for 12 to 15-year-old kids, the PR firm told parents that schools could open in fall 2021 only if they got their kids vaccinated. These ads never mentioned side effects like myocarditis due to the vax.
HHS has scrubbed the propaganda ads from this era from its web pages. It’s easy to see why. They are embarrassing. They tell kids, in effect, that they should treat other kids like biohazards unless they are vaccinated.
When the Delta variant arrived, the PR firm doubled down on fear-mongering, masking, and social distancing.
In September 2021, CDC director Walensky overruled the agency’s external experts to recommend the booster to all adults rather than just the elderly. The director’s action was “highly unusual” and went beyond the FDA’s approval of the booster for only the elderly.
The PR campaign and the CDC persistently overestimated the mortality risk of Covid infection in kids to scare parents into vaccinating their children with the Covid vax.
In Aug. 2021, the military imposed its Covid vax mandate, leading to 8,300 servicemen being discharged. Since 2023, the DOD has been trying to get the discharged servicemen to reenlist. What harm has been done to American national security by the vax mandate?
The Biden/Harris administration imposed the OSHA, CMS, and military vax mandates, even though the CDC knew that the Delta variant evaded vaccine immunity. The PR campaign studiously avoided informing Americans about waning vaccine efficacy in the face of variants.
The propaganda campaign hired celebrities and influencers to “persuade” children to get the Covid vax.
I think if a celebrity is paid to advertise a faulty product, that celebrity should be partially liable if the product harms some people.
In the absence of evidence, the propaganda campaign ran ads telling parents that the vaccine would prevent their kids from getting Long Covid.
With the collapse in public trust in the CDC, parents have begun to question all CDC advice. Predictably, the HHS propaganda campaign has led to a decline in the uptake of routine childhood vaccines.
The report makes several recommendations, including formally defining the CDC’s core mission to focus on disease prevention, forcing HHS propaganda to abide by the FDA’s product labeling rules, and revamping the process of evaluating vaccine safety.
Probably the most important recommendation: HHS should never again adopt a policy of silencing dissenting scientists in an attempt to create an illusion of consensus in favor of CDC groupthink.
You can find a copy of the full House report here. The HHS must take its findings seriously if there is any hope for public health to regain public.
Dr. Jay Bhattacharya is a physician, epidemiologist and health economist. He is Professor at Stanford Medical School, a Research Associate at the National Bureau of Economics Research, a Senior Fellow at the Stanford Institute for Economic Policy Research, a Faculty Member at the Stanford Freeman Spogli Institute, and a Fellow at the Academy of Science and Freedom. His research focuses on the economics of health care around the world with a particular emphasis on the health and well-being of vulnerable populations. Co-Author of the Great Barrington Declaration.
Fluoride Finally Declared an “Unreasonable Risk”
A look at the ruling that will have a widespread impact on the health of all American children
By Aaron Siri | Injecting Freedom | October 25, 2024
A seven-year battle between the EPA and the public interest regarding the fluoridation of public drinking water has finally concluded. This is an excellent result by Siri & Glimstad partner Michael Connett in securing a court order against the EPA. Great job, Michael!
U.S. District Court Judge Edward Chen concluded the following in his ruling:
“[T]he Court finds that fluoridation of water at 0.7 milligrams per liter (“mg/L”) – the level presently considered “optimal” in the United States – poses an unreasonable risk of reduced IQ in children… [A] risk sufficient to require the EPA to engage with a regulatory response…”
“There is little dispute in this suit as to whether fluoride poses a hazard to human health. Indeed, EPA’s own expert agrees that fluoride is hazardous at some level of exposure. And ample evidence establishes that a mother’s exposure to fluoride during pregnancy is associated with IQ decrements in her offspring. The United States National Toxicology Program (“NTP”) – the federal agency regarded as experts in toxicity… concluded that fluoride is indeed associated with reduced IQ in children, at least at exposure levels at or above 1.5 mg/L (i.e., “higher” exposure levels)…”
“In all, there is substantial and scientifically credible evidence establishing that fluoride poses a risk to human health; it is associated with a reduction in the IQ of children and is hazardous at dosages that are far too close to fluoride levels in the drinking water of the United States. And this risk is unreasonable under Amended TSCA. Reduced IQ poses serious harm. Studies have linked IQ decrements of even one or two points to e.g., reduced educational attainment, employment status, productivity, and earned wages.”
The NTP report referred to above can be found here. While we wait for the EPA to take the next step, many municipalities have already acted to remove fluoride from their water systems.
NIAID Declares Mpox Vaccine ‘Safe’ for Teens, Opening the Door for Vaccine’s Approval for Kids as Young as 12
By Michael Nevradakis, Ph.D. | The Defender | October 18, 2024
The National Institute of Allergy and Infectious Diseases (NIAID) this week announced Bavarian Nordic’s mpox (monkeypox) vaccine is “safe and generates a robust antibody response in adolescents.”
The announcement drew criticism from doctors and scientists who cited the lack of any evident control group in the clinical trials and any publicly available data.
The results of the NIAID study, funded by the National Institutes of Health, could open the door for the vaccine’s approval for 12- to 17-year-olds in the U.S., a month after European regulators approved the vaccine for the same age group.
According to the Oct. 16 announcement, the modified vaccinia Ankara-Bavarian Nordic (MVA-BN), marketed as Jynneos in the U.S., “generated antibody levels in adolescents equivalent to those observed in adults at day 43 and found that the vaccine was well tolerated through study day 210.”
The results are based on a pair of Phase 2 clinical trials of the MVA-BN vaccine. One trial included 229 participants between 18 and 50 years old, while the other trial tested the vaccine on 315 adolescents between ages 12 and 17.
Based on the findings, the European Medicines Agency (EMA) last month approved the MVA-BN, marketed as Imvanex in Europe and the United Kingdom, for 12- to 17-year-olds.
“The immune response in adolescents was similar to adults. … According to the submitted data, the safety profile of Imvanex in adolescents was comparable to that seen in adults and no additional risk has been identified,” the EMA stated in its Sept. 19 announcement.
Last month, the World Health Organization (WHO) approved MVA-BN for adults — and said it can be used for babies, children, teens and pregnant women if they are in “outbreak settings where the benefits of vaccination outweigh the potential risks.”
The U.S. Food and Drug Administration (FDA) in September 2019 approved the Jynneos vaccine for adults, for the prevention of both mpox and smallpox and added it to the Strategic National Stockpile.
The approvals went through even though no data on the MVA-BN clinical trial results for the 12-17 age group have been publicized.
‘The complete void of any transparency in this clinical trial is stunning’
Critics of the vaccine cited the lack of data for 12- to 17-year-olds, the lack of a control group in the clinical trials, and questioned the necessity and safety of administering the mpox vaccine to children.
“The complete void of any transparency in this clinical trial is stunning,” said Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense. He added:
“Also, the clinical trial had no unvaccinated control group for comparison, which is a fatal flaw even if they would have made the trial results public. These are supposedly the premiere clinical researchers worldwide, yet they make 9th-grade mistakes in running their experiments.”
A spokesperson for NIAID who spoke with The Defender directed the public to the study protocol for the two clinical trials. However, the protocol does not indicate a control group and contains no findings.
“Short-term antibody responses in a study with an undisclosed sample size and no reported safety data are not sufficient for an NIAID press release,” cardiologist Dr. Peter McCullough told The Defender.
McCullough said:
“The Jynneos monkeypox vaccine has been used for years and carries a risk of myocarditis or heart damage. This study is not reassuring on safety or theoretical efficacy. The NIAID should take this post down and wait for the full peer-reviewed manuscript to be published.”
Internist Dr. Meryl Nass questioned the need for the MVA-BN clinical trials and NIAID’s claims of insufficient data for people 18 and younger. She told The Defender the studies were performed “after the U.S. government already gave hundreds of thousands of Americans both doses in mid-2022 and collected data on them.”
“One wonders what the purpose of this tiny trial was,” Nass said.
Data indicate a potentially high risk of severe adverse events
According to the NIAID announcement, “The overall frequency of adverse events was comparable between the study groups. Reports of dizziness were more common in adolescents than adults, but similar to the frequency of dizziness reported when other vaccines are administered in adolescents.”
The study results for the 18- to 50-year-old group indicated a rate of severe adverse events exceeding 1%. For Nass, a “1% SAE [severe adverse event] rate for a vaccine is very high,” though she added, “We need to know more to make any safety judgment.”
Nass suggested the actual number of severe adverse events may have been underreported.
“NIAID claims that only two of the 229 subjects had a serious adverse event. However, their definition of serious has been made more and more restrictive over the years,” Nass said.
According to Nass, while NIAID’s definition of a serious adverse event once “included an ER [emergency room] visit after vaccination,” the current NIAID definition is narrower, referring, in part, to “inpatient hospitalization or prolongation of existing hospitalization” instead of an ER visit.
The two reported severe adverse events in the 18-50 age group involved cases of cystitis — an inflammation of the bladder — and euglycemic diabetic ketoacidosis, an “uncommon diabetic complication.”
Nass also noted that severe adverse event data were “collected only for the first 57 days of the study.” In the event NIAID determined the adverse event was related to vaccination, further data were collected through day 181 — even though “blood was drawn at day 365 also.”
“Why were SAEs not collected through day 365 for everyone? That is how you learn what the SAEs related to a vaccine actually are,” Nass said.
Data from the U.S. government’s Vaccine Adverse Event Reporting System (VAERS) as of Sept. 27 indicate 2,115 reports of adverse events related to MVA-BN, including 19 reports for people under 18.
According to Managed Healthcare Executive, “Bavarian Nordic is preparing for a clinical trial to assess the safety of MVA-BN in children 2 to 12 years of age.”
The trial will be partially funded by the Coalition for Epidemic Preparedness Innovations, which previously announced its intention to develop “pandemic-busting vaccines in 100 days.”
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.
‘Childish Temper Tantrums’ – Australian Councilor Fires Back at Pressure From Authorities
By Anatoly Donstov – Sputnik – 24.10.2024
Following his powerful interview with Sputnik, Adrian McRae, businessman and member of the Town of Port Hedland Council in Australia, has been urged to resign by Western Australia Premier Roger Cook in a desperate attempt to silence him.
“Earlier this week, before the Premier had heard I was in Russia, he suggested that the entire Town of Port Hedland Council should get back to “knitting” when we demanded him to show us evidence that the Covid-19 vaccines were safe… So, instead of acting like a true leader, … he attacks me personally and resorts to ad-hominem – the last refuge of a failed argument. I feel sorry for him actually. I don’t know what I’d do if I was in his shoes,” McRae told Sputnik, explaining Cook’s “contempt” towards him and “all West Australian Councilors.”
On Wednesday, the Premier called for the resignation of McRae, labeling him “an embarrassment” after his interview with Sputnik, ABC reported. In the interview, the businessman criticized Australian and Western media for biased coverage of Russia and challenged the narrative portraying Moscow as the enemy.
McRae warned that free speech is under threat in the West, while BRICS countries still offer hope for its protection. As an observer in the 2024 Russian presidential election, McRae praised the transparency of the process, drawing heavy criticism from Australian media.
“It’s simple. The Premier is using the boogeyman of Russia to attempt to ruin my character in hopes of people forgetting about the important questions my entire Council has asked him regarding the mRNA vaccine contamination. He is deflecting the subject to the best of his very limited ability and making an absolute fool of himself in the process,” McRae told Sputnik, explaining why Cook has gone to such lengths to smear him.
Despite the Premier’s desperate attempts to suppress the council member, McRae remains a strong voice against Western censorship and political corruption, with Sputnik delivering the uncensored truth that the West fears.
“Sadly for the Premier, I have truth and science on my side. He, on the other hand, has nothing but a dying prostitute media and a really poor scriptwriter. So no, I am not too concerned about the Premier and his childish temper tantrums,” McRae said confidently, undeterred by the threats from the Western Australia Premier.
Dark Money, Darker Motives: Why is Bill Gates Backing Kamala Harris Using Shady Super PAC?
By Ilya Tsukanov – Sputnik – 23.10.2024
Tech billionaire, philanthropist and WEF cheerleader Bill Gates has given Kamala Harris’s campaign a $50 mln boost using dark money super PAC Future Forward. The donation was intended to remain secret, but was uncovered by NYT this week.
What’s Future Forward?
Set up in 2018 by former Obama campaign staffers and coming out of left field in the final weeks of the 2020 race to fund a massive pro-Biden media blitz, Future Forward is a super political action committee funded mostly by Big Tech and venture capital firms, including Meta, Google, disgraced crypto financier Sam Bankman-Fried, Bain Capital and Bridgewater Associates.
The super PAC has raised a whopping $700 mln for the 2024 election cycle, rolling out $75 mln in pro-Harris ads last week.
What’s Behind Gates’ Electoral ‘Generosity’?
2024 is at least the second election cycle where Gates has used a dark money vehicle to support the Democratic Party’s candidate. In 2020, the Bill and Melinda Gates Foundation contributed nearly $70 mln to the New Venture Fund, a nonprofit belonging to DC consultancy Arabella Advisors, which bankrolls the Sixteen Thirty Fund, a goliath of undisclosed donations for Democratic politicians and liberal causes which raised nearly $390 mln four years ago. Publicly, Gates and his now former wife also gave $500,000 to Biden’s inaugural committee.
Mr. Gates has been an active supporter of Democratic candidates since at least 2008, contributing financially to and praising the campaigns of Barack Obama and Hillary Clinton.
Gates’ ties to the Clintons are deeply rooted, with the billionaire becoming a top donor to the Clinton Foundation, and forging partnerships with the organization for global projects since at least 2013.
In a telling interview in 2016 in which he explained his preference for Clinton, Gates said “there have been questions about vaccines in general where some of the candidates have shown that they’re not as up to date about vaccines in general, and that’s got to be a concern.”
“Science in general, whether it’s GMOs or vaccines, there’s a lot of people out there who don’t give science the benefit of the doubt. In terms of experience, Hillary Clinton and Bill Clinton have more experience in global health,” Gates said at the time.
How has Gates profited off the Dems’ agenda?
With Harris’ presidential bid expected to broadly continue the Biden/Clinton line on foreign and domestic policy, it makes sense for Gates to throw his influence behind the VP, given the perceived threat of the Trump brand of red-pill MAGA Republicans and their anti-vax, anti-tech, and anti-interventionist leanings.
“This election is different, with unprecedented significance for Americans and the most vulnerable people around the world,” Gates said this week after info about his $50 mln donation leaked out.
“I think it’s great to have somebody who’s younger, who can think about things like AI and how we shape that in the right way, and I certainly offer up my opinions to the politicians who are interested,” Gates said this summer after Biden dropped out and named Harris his successor.
The Gates Foundation’s fortunes got a big boost under Biden, with its endowment growing from $69 bln in 2020 to $75.2 bln in 2023.
Gates enjoyed a profits bonanza off mRNA coronavirus vaccines mandated by the Biden administration. In 2022, he sold off shares of BioNTech stocks he bought in 2019 as sales slowed. His foundation has also owned shares in Pfizer, CureVac and Vir Biotech going back to well before the pandemic.
The billionaire’s foundation supports the Global Virome Project – an ambitious initiative created in 2018 to predict pathogens that could trigger lethal pandemics, but accused of weaponizing viruses from a network of 150 biolabs worldwide.
Gates has also backed a broad array of World Economic Forum-affiliated initiatives, including projects to reduce emissions and create synthetic meat and dairy. In 2022, The Seattle Times revealed Gates’ secret lobbying to save Biden’s signature $2+ trln Build Back Better social and climate spending package.
Gates has also been a top backer of the Biden administration’s battle against media and online ‘misinformation’, with an explosive MintPress investigation from 2021 revealing that his foundation had bankrolled some $319 mln in media, including CNN, the BBC, Le Monde, the Financial Times, Der Spiegel and others to ensure favorable coverage of his agenda and that of his allies.
EU President Likens Free Speech to Infectious Disease
Ursula von der Leyen advocates “pre-bunking” in the public forum to “vaccinate” people against “disinformation”
By John Leake | Courageous Discourse | October 23, 2024
EU President Ursula von der Leyen just joined the ranks of former Senator John Kerry and other globalist ghouls in declaring war on free speech by perversely proclaiming that the EU citizenry needs to be “vaccinated against disinformation.”
Like every censor in history, she characterizes her censorship program as a means of expunging erroneous information and ideas from public discourse. By using the word “disinformation,” she implies that she and her clique are already the sole possessors of the truth about everything, and that everyone who has and shares heterodox ideas is necessarily in error.
Her entire premise is FALSE for the following reasons:
1). Knowledge about the world is constantly evolving through constant inquiry, discussion, and dissemination. Knowledge is NOT a static thing. This is why countries with stifling censorship regimes have experienced intellectual, scientific, and artistic stagnation. Their rulers try to freeze the human mind in its state at their moment in history.
2). NO state, university, or ecclesiastical committee has ever been in possession of the full truth of any matter. Official orthodoxies have always been challenged by heterodox thinkers. Indeed, virtually every major advance in human insight has been performed by heterodox thinkers.
3). As John Milton observed in his 1644 pamphlet, Areopagitica, contending with error is an intrinsic part of learning and discovery. We literally learn by making mistakes and correcting them. If free speech is suppressed for the objective of preventing the propagation of erroneous thought—or “vaccinating against it”—it will become extremely difficult if not impossible for people to learn and discover.
4). Without a single exception in history, the people who hold power always advocate the orthodoxy that sustains and extends their power and that of their friends and supporters.
Ursula von der Leyen is the quintessence of this principle. As president of the EU, she conducted secret negotiations with Pfizer CEO to purchase a 20 billion Euros of Pfizer’s fraudulent and dangerous vaccine so that it could be inflicted on all the citizens of the European Union. She is currently under criminal investigation for her conduct in this affair that has come to be known as Pfizergate.
It takes a special kind of chutzpah for a powerful state official who is probably guilty of committing a major crime—a crime that has been systematically and ruthlessly concealed—to lecture the public about the need for censorship. The time has come for the citizens of Europe to rid themselves of Ursula von der Leyen and her clique of corrupt tyrants.
To be sure, there is increasing evidence that the Biden Administration has been exerting pressure on Germany—which remains an American vassal state—and the EU to step up its censorship regime. I will cover this strange development in a subsequent post.
Fired for Free Speech: Alison Morrow’s Battle Against Government Censorship
By Dan Frieth | Reclaim The Net | October 19, 2024
Alison Morrow (formally Westover), an accomplished journalist, found herself in the throes of a legal battle over her right to free speech. Represented by the Silent Majority Foundation, Morrow has filed a lawsuit against the Washington State Department of Natural Resources (DNR) and its top officials, citing wrongful termination after she was dismissed for airing an interview on her YouTube channel. The channel, a personal project crafted during her tenure as an environmental reporter at KING 5 in Seattle, became the subject of controversy following her post featuring a highly censored doctor, Dr. Aaron Kheriaty, and his views on COVID-19.
We obtained a copy of the lawsuit for you here.
Morrow’s career at KING 5, which spanned from 2013 to 2019, was marked by significant accolades, including two Emmy awards. Recognized for her independent journalism, DNR was fully aware of her YouTube activities when they recruited her as a communications specialist. Initially, her independent media pursuits were supported by DNR, but the tide turned with her decision to feature Dr. Kheriaty. DNR’s leadership warned Morrow that her continued interviews could lead to termination, a threat she met with a staunch refusal to abandon her First Amendment protections.
Determined to uphold her freedoms of speech, press, and association, Morrow chose to defy DNR’s directive to adhere to approved narratives. This act of resistance ultimately led to her dismissal, prompting her to seek legal assistance from the Silent Majority Foundation, which took up her case to safeguard these fundamental rights.
“The 1st Amendment is one of the most sacred rights of Americans. It is what differentiates our country from most others, that we have the freedom to question our government. It is also central to a free press. I was willing to lose my job – and all that it provided for our family – in order to stand up against the encroaching erosion of this right that I was witnessing at the time, not just in my case but in thousands of others across the country during the pandemic,” Morrow stated. “There was no way to do science or journalism, in the culture of censorship that was driven by our government at the time. That meant millions of people made decisions without informed consent. Given my commitment to seeking truth wherever it leads, I was unwilling to acquiesce to a demand that I remain silent.”
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Rabbi Shmuel Eliyahu: Leave No Palestinian or Arab Alive
By Jonas E. Alexis | Veterans Today | July 23, 2017
Israeli Rabbi Shmuel Eliyahu seems to have picked up where the late Rabbi Ovadiah Yosef left off. The Israeli army, Eliyahu said, must slaughter the Palestinians “and leave no one alive.” The Palestinians, the good rabbi continued, must be “destroyed and crushed in order to end violence.” Here is Eliyahu’s algorithm:
“If they don’t stop after we kill 100, then we must kill 1,000. And if they do not stop after 1,000, then we must kill 10,000. If they still don’t stop we must kill 100,000, even a million.”
There is more to this “logic” than meets the eye and ear. Eliyahu even postulated that the Israeli army ought not to get involved in arresting Palestinians because “If you leave him alive, there is a fear that he will be released and kill other people. We must eradicate this evil from within our midst.”
You may say that this is just an isolated case. No Israeli official believes that, right? … continue
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