Clinical trial data released earlier this week in an FDA briefing document showed that rather than preventing RSV disease in small children, Moderna’s vaccine likely caused higher rates of severe RSV illness in its Phase 1 clinical trial.
Moderna halted the trial in July after it was informed that two babies in the vaccine group had developed severe RSV disease. The company didn’t publicly announce that the trial was discontinued until September.
The data presented Thursday at the Vaccines and Related Biological Products Advisory Committee meeting showed that 12.5% of vaccinated children developed severe RSV disease as compared to just 5% of children in the placebo group.
Among the children who developed symptomatic RSV disease, 26.3% in the vaccinated group progressed to severe disease, while only 8.3% of those in the placebo group did.
These results were concerning given the history of past attempts to develop an RSV vaccine for infants. In the 1960s, an experimental formalin–inactivated RSV vaccine for children led to two toddler deaths, and 80% of vaccine recipients required hospitalization for severe RSV.
The illnesses were attributed to vaccine-associated enhanced respiratory disease (VAERD) — a phenomenon that occurs when vaccination promotes immune responses that exacerbate the disease caused by subsequent infection with the pathogen the vaccine was meant to protect against.
In light of that history, and because the mechanisms that cause VAERD are still largely unknown, the FDA convened the advisory committee to discuss the implications of Moderna’s trial outcomes for other pediatric RSV vaccines.
The committee did not vote on Thursday or make any formal recommendations. Members watched presentations from consultants, the FDA, and pharmaceutical companies and discussed the risks and benefits of developing RSV vaccines for children.
They also commended Moderna for reporting its results and the existing clinical safeguards for recognizing early safety signals in pediatric RSV trials.
Vaccine makers developing 26 different RSV vaccines or monoclonal antibodies
The briefing document stated that the FDA was halting enrollment for all investigational trials for RSV vaccines for infants and toddlers under age 2 and children ages 2 through 5 who haven’t previously had RSV.
The FDA clarified at the outset of the meeting that the hold does not apply to vaccine candidates that use live attenuated vaccines, because there is no evidence that vaccines developed on this platform cause VAERD.
Advisers seemed to agree, except for Dr. Karen Kotloff who voiced concerns there was not enough information to assume that live attenuated vaccines don’t carry the same potential risk.
There are five pediatric vaccines other than Moderna’s — which Moderna’s Christine Shaw, Ph.D., definitively stated is no longer moving forward — in the pipeline. Four of them are for live-attenuated vaccines.
Vaccine makers are developing 26 different RSV vaccines or monoclonal antibodies for all age groups, all vying to enter a rapidly expanding market.
PR Newswire projected in 2023 the global RSV vaccine and antibody market would be worth $2.61 billion dollars in 2024 and rise to $13.59 billion by 2030.
Piedra — who began his presentation with the quick disclosure that he has grants for RSV prevention research from GSK, Icosavax and Merck and is a paid consultant in the field for Merck, Moderna, Pfizer and Sanofi — presented an optimistic picture of RSV vaccine development, citing protection offered by recently approved maternal vaccines and monoclonal antibodies.
Moderna’s results did raise some platform-specific concerns, Piedra conceded.
He listed the types of safety concerns that could be associated with different vaccine platforms — febrile seizures with adjuvanted or high-dose vaccines or when RSV vaccines are co-administered with other vaccines, autoimmunity that could be associated with new adjuvants, respiratory issues with intranasal vaccines, and systemic illnesses with vector-based or mRNA vaccines.
‘Unmet need’ as justification to push for more RSV vaxes for small children
Presenters repeatedly stated that there was an “unmet need” for pediatric RSV vaccines, especially for children between 8 months and 2 years old.
RSV usually causes mild cold-like symptoms, but in some cases can lead to hospitalization and death in infants and the elderly. By age 2, 97% of all babies have been infected with RSV, which confers partial immunity, making any subsequent episodes less severe.
The disease burden for infants can be serious. In the U.S., RSV infection is the leading cause of infant hospitalization among those younger than 6 months, although a very small percentage of children with the virus will die.
An FDA representative said the Centers for Disease Control and Prevention (CDC) estimates that 100-200 infants die per year from the disease. However, internist Dr. Meryl Nass told The Defender that even those low numbers may overestimate mortality.
Nass pointed to a CDC study analyzing RSV deaths in infants between 2005 and 2016 and found a total of 314 deaths in children under age 1, or 25 on average per year, Nass reported. Only 17 of those deaths per year listed RSV as the underlying cause of death.
The FDA also said that maternal vaccines and monoclonal antibodies had begun to reduce those numbers, but emphasized there is still an “unmet need” for a vaccine for children going into their second RSV season — even as it presented data showing hospitalizations in that season are lower.
Moderna said this “unmet need” drove them to develop their failed vaccine. A Sanofi representative, who gave an update on their live-attenuated RSV virus, said the company sought to meet that “unmet need” for children in their second RSV season.
Sanofi also sells nirsevimab — brand name Beyfortus — the monoclonal antibody shot the CDC recommends for all newborns to protect them in their first RSV season.
Sanofi and the National Institutes of Health (NIH) are collaborating on the live-attenuated virus vaccine platform. The NIH developed 16 different vaccine candidates that it trialed in children and currently has one SP-125 in Phase 3 clinical trials.
These vaccines have not shown VAERD after one season of surveillance, the Sanofi representative said. The safety trials showed no safety concerns and SP-125 is currently being tested for efficacy in toddlers 6-22 months of age, but it is not yet fully enrolled.
During the “public comments” section of the meeting, three other vaccine makers promoted their vaccines to the committee.
Goal is more RSV shots for kids to provide passive immunity followed by ‘active immunity’
FDA asked the committee members to discuss existing evidence on whether infants and toddlers could eventually get sequential administration of RSV monoclonal antibodies followed by RSV vaccines.
That would mean even more shots on the childhood immunization schedule. The monoclonal antibodies or maternal vaccination would provide babies with “passive immunity” — antibodies to fight the virus that weren’t created by their own immune systems.
Then, in this schema, a two- or three-shot course of an RSV vaccine could protect babies from RSV in the second season, giving them “active immunity.”
Most committee members said more data were necessary to evaluate the safety of such a plan, but they generally agreed that it was a good direction to move in.
When the nomination of Robert F. Kennedy, Jr. as Health and Human Services Secretary comes before the Senate, the specter of the Samoan measles outbreak of 2019 will dramatically be invoked to challenge him. Kennedy’s critics have repeatedly relied on this topic, citing stories that claim he was responsible for an epidemic in 2019 that caused at least 83 children to die due to vaccine hesitancy. In recent articles, reporters quote previous news coverage relying on unsubstantiated and minimal data to justify their analysis.
These stories repeat dubious assertions, fail to discuss any pathological analysis, and dismiss Kennedy’s considered support of healthcare in Samoa. He had assisted the Samoan government in developing a system for health officials to assess the efficacy and safety of medical interventions or drugs, including vaccines.
In November 2019, while the deaths of Samoan children were rapidly increasing, Kennedy wrote a comprehensive letter to the Samoan Prime Minister, presenting some possible causes of the unprecedented, virulent outbreak of measles. His concerns about the epidemic in Samoa highlight striking anomalies that were apparent to a few investigators at the time, although they remain unexplained.
The most convenient and generally accepted explanations of the outbreak claim the epidemic was the result of hesitancy, causing the population to be under-vaccinated. Measles vaccination rates were low due to the previous deaths of two infants given improperly formulated injections, which had nothing to do with Kennedy’s views.
Any considered analysis of the accessible facts soundly contradicts the conjecture that the high death count was related to low vaccination rates.
In most measles epidemics, mortality is on average one in one thousand, and dying children are often malnourished or immunocompromised. From October through December of 2019, over one in a hundred Samoan children with the disease died, ten times more than any previous outbreak in the world. No accounting for this overt statistical deviance has been published.
Despite the presumptions of those who attack Kennedy, there was never any investigation into any aspect of this baffling tragedy. Edwin Tamasese, a health advocate who questioned Samoan government policies during the outbreak, gave Kennedy some insight into what was happening.
Tamasese was concerned about the number of sick and dying Samoan children and began to assist families whose children were severely ill. He and his colleagues encountered conditions that contradicted the government’s narrative.
While the press condemned him as an anti-vaxxer, Tamasese’s interventions and observations are revelatory. In an interview after the outbreak subsided, he said, “We were very careful to take statistics when we were going in to try to identify trends. When we assessed our numbers, 98 percent of those who were getting ill had been vaccinated consistently six to seven days prior to illness. The excuse was that the vaccine did not have time to become effective. However, according to an immunologist on the team, the six to seven-day period was also the length of time it would take an under-attenuated vaccine to make the recipient sick.”
Doctors in hospitals also reported that the very ill and dying children did not have symptoms consistent with normal cases of measles. When the outbreak began, blood from the first thirty-nine cases had been sent to Australia; only seven samples were positive for measles.
The government stopped testing to confirm the cause of these deaths in early November 2019. Without scientific confirmation, illness and mortality were attributed to low immunization rates. Samoan health authorities continued to claim that the only remedy for the deadly epidemic was a drive to increase vaccination; however, the campaign appeared to increase the number of measles cases.
Neighboring Pacific island countries, Tonga and Fiji, which had concurrent outbreaks of the virus — and had a different source of the measles vaccine — did not suffer the same dramatic mortality rates. This should have raised concerns, yet there hasn’t been an inquiry into why the Samoan government switched vaccine sourcing from India to Belgium midway through the crisis.
A renewed effort to vaccinate with this alternate supply began in the first week of December 2019; it was hailed as the reason the outbreak subsided. Measles vaccines take at least 10 days before creating an immune response. There has been no explanation for the data confirming that the onset of cases dropped dramatically two weeks before this vaccination drive could have had any effect.
The government response was not driven by factual analysis; the effort focused on promoting the vaccine and silencing those questioning authority.
With Samoan officials and the press deriding his work and views, Tamasese was arrested and charged with incitement of a government order and treating children without a license. Although this was deemed appropriate justice by the international news media as they echoed the government’s praise of the vaccine, reporters again failed to present the questions raised by the outbreak.
The prosecution’s primary witness against Tamasese was a nurse whose child had measles. He had suggested that administering vitamins A and C could be helpful — and standard medical treatment for measles patients. She had taken his advice and admitted that her child recovered soon afterward.
Tamasese reported that when the nurse left the courtroom, the judge, in throwing out the case, said, “That witness may as well have represented the accused.” There was relative silence from the news media when all charges against him were dismissed.
While worldwide attention on Samoa ignored dramatic inconsistencies, Kennedy was one of the few people who asked detailed and important questions. His views were marginalized; it was easier and politically correct to blame the tragedy on low rates of vaccination.
The relatively few details known about the Samoan measles outbreak indicate that forces intent on presenting vaccines as an infallible, unquestionable remedy will not tolerate scrutiny or admit failures. This continuing devious tactic is applied internationally and is eagerly supported by most governments and the press.
Analysis of the Covid-19 pandemic has only recently vindicated those who were scorned for questioning the response. The parallels to the unfolding of the epidemic in Samoa are not obscure, and support Kennedy’s contention that vaccine development, manufacturing, and application need much more effective evaluation and monitoring to prevent complications and death.
When the US government assures the public that any vaccine or medication is safe and effective, this must come from an independent, thorough, and transparent process, rather than relying only on the words and actions of those with vested interests.
The current criticism of Kennedy is an endeavor to make him look dangerously ignorant and irresponsible to sway members of the Senate. Much to the chagrin of those who vilify him, his efforts to understand and assist in the Samoan measles outbreak exemplify his thoughtfulness and capabilities.
RFK, Jr. is at the forefront of healthcare oversight; his confirmation as HHS Secretary will ensure that Americans benefit from his experience and knowledge.
Today, the Africa Centres for Disease Control and Prevention live streamed a special briefing regarding the so-called ‘Disease X’. In the briefing, they shared that the samples they received “are of poor quality” and were “poorly preserved”. As a result, the lead investigator stated, “Therefore, I don’t think we will obtain any relevant information.”
The Africa CDC briefing also reported an increase of 147 cases since last week, bringing the total case count to 527. 32 deaths were recorded in health facilities, while 44 were reported at the community level.
While initial lab results suggest this could simply be malaria, the coordinated fear campaign persists. Even the most recent Africa CDC briefing overlooks the possibility that it could be malaria. This raises questions about whether something else might be at play. We will continue to monitor the situation closely.
Nicolas Hulscher, MPH
Epidemiologist and Foundation Administrator, McCullough Foundation
A Canadian doctor who was censored for discussing Covid topics during the pandemic is taking her legal battle to the country’s Supreme Court, in a bid to have free speech restrictions imposed on her finally removed.
Dr. Kulvinder Kaur Gill made the decision after the Ontario Court of Appeal ruled to uphold three “cautions” she received for tweets opposing what she considered to be harmful Covid lockdowns, published in August 2020.
These cautions were issued by the College of Physicians and Surgeons of Ontario (CPSO) in February 2021. The state’s medical regulator in 2020 warned medical professionals that the opinions they express should be in line with whatever the government or public health institutions decide is the correct information.
That included lockdowns, which Gill openly criticized early on, and continues to believe were ineffective in dealing with the pandemic. Besides her opinion, Gill also offered what her legal counsel says is “ample evidence” to CPSO to support her stance on the ineffectiveness of lockdowns.
As for the cautions, the doctor believes CPSO used them to censor her right to free expression, guaranteed by Canada’s Charter of Rights and Freedoms.
Twitter, where she posted her thoughts on the situation developing in 2020, has in the meantime become X, and this social platform is now supporting her by covering the legal costs, as she continues her effort to appeal against CPSO-imposed speech restrictions.
Those costs amounted to $6,000 as the lower court ruled to uphold the regulator’s decisions that targeted Gill in 2021.
Gill expressed her gratitude to X and Elon Musk for the support, and provided links about the details of the case in a post, saying that to “first do no harm” as a physician meant opposing lockdowns – and that this triggered a 5-year “unjust journey” for her.
“The growing overreach of regulators into monitoring the speech of professionals on social media has become a matter of national concern to the public, which loses the benefit of hearing a variety of opinions when professionals’ speech is chilled out of fear of punishment,” Gill’s lawyer Lisa Bildy said in a statement.
According to Bildy, her client spoke against lockdowns and other harmful Covid-era mandates aligning evidence-based concerns and her conscience – rather than obeying CPSO’s “edict” to align with whatever the authorities decided were the right measures.
Pfizer-BioNTech did not disclose the deaths of two vaccinated participants in its COVID-19 vaccine clinical trials, according to a team of Daily Clout researchers who analyzed documents related to the Pfizer clinical trials.
The deaths occurred before the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for the vaccine in December 2020. However, it wasn’t until September 2023, nearly three years later, that the FDA publicly released documents revealing the deaths of a 63-year-old Kansas woman and a 58-year-old Georgia woman who participated in the trials.
The revelations prompted Dr. Jeyanthi Kunadhasan — an Australian anesthesiologist and perioperative physician and one of the researchers analyzing the Pfizer documents on behalf of Daily Clout — to write to Kansas Attorney General Kris Kobach, requesting his office investigate the death of the 63-year-old Kansas woman.
“If the additional two deaths had been disclosed at the time of the EUA, it would have shown that the BNT162b2 mRNA COVIDvaccine intervention provided no reduction in deaths,” Kunadhasan wrote in her letter.
In June, Kobach sued Pfizer, alleging the company misled the public by marketing its COVID-19 vaccine as “safe and effective” while concealing known risks — including myocarditis and pericarditis, failed pregnancies and deaths — and critical data on limited effectiveness.
Pfizer also did not disclose the deaths — both classified in the documents as “sudden cardiac death” unrelated to the victims’ vaccination — in a December 2020 New England Journal of Medicine paper touting the “safety and efficacy” of the Pfizer-BioNTech vaccine.
Kunadhasan told The Defender :
“The death highlighted in Kansas is significant as it occurred well within the reporting period considered for the EUA, and as my letter shows was not disclosed. There was every opportunity to disclose this death at the VRBPAC meeting.
“This death even had an autopsy, which I show was probably available before the VRBPAC meeting, and again was not disclosed.”
According to The Sentinel, “The fact that both participants died of heart attacks becomes more important when other studies showed risks of myocarditis and pericarditis — particularly after a second shot and particularly in young men under 25, but among other patients as well.”
Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), told The Defender the actions of Pfizer and the FDA are “duplicitous at best.” He said:
“All death data for clinical trials needed not only to be made available to the FDA but also to the public. Otherwise, informed consent is completely missing, regardless of whether the product is EUA or [fully] approved.
“It is also particularly devious that Pfizer lied about a reduction in deaths in the vaccination arm when, with these data, the opposite was true.”
Naomi Wolf, Ph.D., CEO of Daily Clout and author of “The Pfizer Papers: Pfizer’s Crimes Against Humanity,” told The Defender the documents show that the “FDA covered up the unlawfully concealed deaths” of the trial participants and that these records “may well reveal a direct connection to the mRNA injection.”
“The details that Dr. Kunadhasan and her colleagues revealed about the death of this poor woman could theoretically allow Kobach to demand the autopsy reports and interview witnesses with information about her passing,” Wolf said.
Dr. Chris Flowers, a retired radiologist and member of the Daily Clout team that examined the Pfizer documents, told The Sentinel that the two undisclosed deaths should have been enough to halt the clinical trial.
“If you put it in context, yes, there’s a small number of deaths,” Flowers said. “Normally, the FDA calls a stop to those clinical trials until further investigation is done. And in many cases, [this] is sort of the death knell of that clinical trial.”
Noting that these deaths “would have at least made it more difficult” for the FDA to grant the Pfizer-BioNTech vaccine an EUA, Hooker said that “to release this information over two years later, after the obvious damage has been done, is criminal. Pfizer should be held accountable.”
Wolf said that while she’s “not an attorney, fraud, negligence and manslaughter come to mind.”
“This was one of the most important clinical trials in modern medical history,” Karl Jablonowski, Ph.D., senior research scientist at CHD, told The Defender. “The people in political power chose to ‘trust the science,’ and they were wrong to do so.”
Undisclosed deaths may have led to FDA granting EUA ‘on incorrect premises’
In her letter, Kunadhasan said she wants to draw attention to “an undisclosed participant death from Kansas that occurred in the BNT162b2-vaccinated arm of Pfizer’s clinical trial.”
According to the documents Kunadhasan cited, the death of the Kansas woman occurred “well before the data cutoff date of November 14, 2020” and nearly a month before the December 2020 VRBPAC meeting.
She said there was a 37-day delay in reporting the results of the Kansas woman’s autopsy, which revealed “sudden cardiac death,” Kunadhasan noted.
“Notably, the omission of the deaths and autopsy report from the vaccinated arm of the study at this critical juncture of EUA issuance raises substantial concerns about the overall safety reporting of Pfizer’s clinical trial,” Kunadhasan stated in the letter.
Kunadhasan also told the attorney general that Pfizer’s clinical trial protocol required that serious adverse events be reported: “immediately upon awareness, and under no circumstances to exceed 24 hours … Pfizer-BioNTech’s own clinical trial protocol indicated that it should have been disclosed.”
Referring to the New England Journal of Medicine paper, Kunadhasan noted that the paper disclosed only six deaths — two among vaccinated clinical trial participants and four among participants in the placebo group.
FDA documents released in September 2023, however, “included information showing that Pfizer-BioNTech was, in fact, informed of two additional deaths in the BNT162b2 arm of the trial well before the EUA data cutoff and that those deaths were not disclosed to the FDA,” Kunadhasan wrote.
The documents showed that the 63-year-old Kansas woman signed up for the Pfizer-BioNTech trial at the Alliance for Multispecialty Research LLC, in Newton, Kansas. She received the two doses of the vaccine on Aug. 18, 2020, and Sept. 8, 2020, and “had appropriate follow-up tests” done on Oct. 7, 2020.
“There is no documentation of any untoward clinical events during these visits,” Kunadhasan wrote. But on Oct. 19, 2020, 41 days after her second dose and less than two weeks after her follow-up visit, the woman died. A subsequent autopsy found the cause of death to be “sudden cardiac death,” not related to the vaccine.
“It is extremely important to know … Why this death (which occurred well within the reporting period) and the autopsy results were not disclosed publicly at the December 10th, 2020, VRBPAC meeting,” Kunadhasan said in her letter.
The letter also highlighted the death of the 58-year-old Georgia woman, who received her two doses of the Pfizer-BioNTech COVID-19 vaccine on Aug. 4, 2020, and Aug. 27, 2020. She died in her sleep on Nov. 7, 2020. Kunadhasan noted that her death was “not added to the data for 26 days.”
Kunadhasan told The Defender these discrepancies prompted her letter to Kobach.
“As a doctor, the non-disclosure of a death and autopsy of a clinical trial participant is a profound betrayal of medical ethics. I hope Kobach pays attention to this, and there can be accountability for this Kansan,” Kunadhasan said.
“Kansans should contact Kobach for action in regards to this letter and other AGs should follow suit with investigating Pfizer’s crimes in their states,” Wolf said.
Kobach’s office did not respond to a request from The Defender for comment as of press time.
Prominent cardiologist joins calls for suspension of mRNA COVID shots
Kunadhasan’s letter comes amid growing calls for a moratorium — or an outright ban — on the mRNA COVID-19 shots, and an independent investigation into their safety.
“There is overwhelming evidence that calls for the suspension of the COVID-19 mRNA vaccine (which, by technicality, is a genetic therapy) because of serious harms,” Malhotra wrote in the letter.
The letter was addressed to Charley Massey, CEO of the U.K.’s General Medical Council; Wes Streeting, the U.K.’s secretary of state for Health; Sir Christopher Whitty, the U.K.’s chief medical officer; and Lord Patrick Valance, the U.K.’s minister of state for Science Research and Innovation.
Malhotra wrote that these officials’ decision “to not support a pause and independent investigation of the safety of the vaccines is now untenable given accumulating evidence of harm and corrupt practices.”
The letter also referred to The Hope Accord — a petition Malhotra drafted earlier this year signed by over 64,000 people, including 1,900 medical doctors and over 2,000 scientists and academics.
The petition calls for the suspension of the mRNA COVID-19 vaccines, “comprehensive re-evaluation of the safety and efficacy of all COVID-19 vaccine products,” “immediate recognition and support for the vaccine-injured,” “restoration of ethical principles” and “addressing the root causes of our current predicament.”
Speaking on medical commentator John Campbell, Ph.D.’s YouTube show on Dec. 11, Malhotra said evidence supporting withdrawal of the vaccines is “overwhelming.”
Explaining why he wrote to U.K. officials, Malhotra told Campbell, “Sunlight is a very powerful disinfectant for malodorous health policy,” and said that there may be an explosion of people in the near future who are currently asymptomatic but who may develop vaccine-related conditions.
“We’ve got a lot of asymptomatic people in the population who I feel are at risk of heart attack, stroke and cancer. Until we get that addressed full on, more people are going to be harmed from a vaccine they took three years ago,” Malhotra said.
“My conscience will not allow me to stay quiet and just do this behind the scenes. As healthcare professionals, we need to address it because it’s not going away.”
“What we need to do is create almost a culture … where people aren’t afraid to admit that things have changed or they’ve got things wrong and they can change their mind,” Malhotra said.
“Do you think there would have been less deaths overall if we hadn’t had a vaccine?”
This question was posed to Dr. Aseem Malhotra by Steven Bartlett during an interview on Bartlett’s podcast Diary of a CEO. To which Dr. Malhotra responded simply “Yes.”
Full Fact, a fact-checking organization, has written a verdict on Malhotra’s answer, claiming: “False. There is clear evidence that the vaccines saved far more lives than they cost.”
While we appreciate Full Fact’s attention to this important question, their verdict is premature, given that the true answer has not yet been conclusively determined by medical science.
Part I: The Illusion of Certainty – Deconstructing Claims of Vaccine Efficacy
The assertion that “There is clear evidence” of Covid-19 vaccines’ benefits outweighing their harms” exemplifies a dangerous oversimplification of complex medical realities. This claim, often propagated by fact-checkers and mainstream narratives, fails to acknowledge the fundamental limitations in our current understanding and the methodological flaws inherent in much of the existing research.
The Missing Gold Standard: Randomized Controlled Trials (RCTs)
In evidence-based medicine, properly conducted RCTs measuring all-cause mortality are the gold standard for determining an intervention’s overall impact. For Covid-19 vaccines, no such trials have demonstrated an all-cause mortality benefit. The original trials were not designed or powered to detect differences in all-cause mortality, and follow-up periods were too short to capture long-term effects. Without this crucial evidence, claims of clear benefit are premature at best and misleading at worst.
The Pitfalls of Observational Studies
In the absence of robust RCT data, fact-checkers often turn to observational studies. However, these studies are fraught with potential biases that consistently overestimate benefit and underestimate harm:
Selection Distortion: Healthy user bias and time-dependent effects inflate apparent vaccine benefits and mask potential harms due to inherent differences in vaccinated groups and changing study conditions.
Temporal Misclassification: Survivorship bias and miscategorization of vaccination status in early post-injection periods artificially inflate efficacy estimates and underestimate potential harms.
Classification Bias: Vaccine status classification errors occur in a single direction, with the vaccinated often misclassified as unvaccinated. This results in infections and harms in the vaccinated being misattributed to the unvaccinated group, overestimating benefit and underestimating harms.
Reporting Bias: Systematic underreporting of adverse events following vaccination due to factors like lack of recognition, dismissal of potential vaccine-related causes, or fear of professional repercussions leads to underestimation of vaccine risks and overstates safety.
Publication Bias: The preferential publication and promotion of studies showing positive vaccine effects, coupled with the suppression or non-publication of studies showing no effect or negative effects, skews the overall body of evidence and public perception.
The Modeling Mirage
Fact-checkers often rely on modeling studies to support dramatic claims of lives saved, compounding the issues of observational studies:
Amplification of Errors: Small inaccuracies in input data or assumptions lead to wildly inaccurate projections
Oversimplification: Complex real-world dynamics are reduced to equations that may not capture crucial nuances
Confirmation Bias: Models can be inadvertently (or deliberately) tuned to produce expected or desired results
Lack of Falsifiability: Unlike controlled experiments, many model predictions are not truly testable
Overconfidence: Precise-looking numbers create a false sense of certainty
In conclusion, modeling studies often use overestimates of benefit taken from observational studies to create oversimplified models tuned to further amplify these overestimated benefits. By extrapolating across millions, they produce unrealistic estimates that can never be verified by proper scientific experimentation.
The magnitude of benefit from Covid-19 vaccines is likely much smaller than portrayed by observational and modeling studies. To determine the net effect of the vaccines, both known harms and potential yet unknown harms must be carefully considered against this uncertain benefit.
Part II: Evaluating the Evidence of Harm
Given the uncertain and likely overestimated magnitude of benefit, it is crucial to consider the potential harms of the Covid-19 vaccines. Dr. Malhotra’s expert opinion that the vaccines may have resulted in a net loss of life for society is justifiable and defensible based on various studies and their logical implications.
Reanalysis of Clinical Trial Data
A re-analysis of the original clinical trials of the mRNA Covid-19 vaccines revealed an increased rate of serious adverse events of 1 in 800. Serious adverse events are defined as either death, hospitalization, or prolonged disability, most of which would certainly reduce life expectancy. Considering that billions of doses have been administered worldwide, this suggests millions may have suffered serious vaccine-induced harms. This rate is orders of magnitude higher than the typically accepted rate of serious harm from other vaccines (approximately 1-2 in a million).
Observational Studies and Autopsy Findings
The high rate of serious harm identified in clinical trials has been corroborated by observational studies from surveillance systems in the US and European Union. Additionally, autopsy studies have confirmed that a significant percentage of deaths occurring within 30 days after Covid-19 vaccination were caused by the vaccine, unequivocally demonstrating that the vaccines can cause death.
It’s worth noting that while observational studies consistently overestimate benefits, they simultaneously underestimate harms due to factors such as healthy user bias, publication bias, reporting bias, and classification bias.
Population-Level Mortality Trends
If the Covid-19 vaccines offered more benefit than harm, we would expect to see decreased excess deaths in highly vaccinated populations after 2021 compared to 2020. However, nearly all nations with high mRNA vaccine uptake experienced higher excess mortality in 2021 than in 2020, contrary to the typical pattern following a pandemic. These elevated excess deaths have persisted beyond 2021, raising concerns about the vaccines’ ongoing impact.
Moreover, since 2022, an overall mortality benefit from the Covid-19 vaccines has become less likely, given that variants have become less deadly, most of the population has been infected, and vaccine efficacy appears greatly reduced. Yet, the serious harm caused by the vaccines likely remains constant, suggesting a worsening harm-benefit ratio over time.
Part III: Current Harm-Benefit Analysis
While uncertainty remains without a Covid-19 vaccine clinical trial testing all-cause hospitalization or mortality, we can attempt an informal harm-benefit analysis using existing data:
Re-analysis of clinical trials found that within the original clinical trials the rate of serious adverse events in the vaccinated was greater than the protection offered against Covid-19 hospitalization
Using UK Health Security Agency observational data on vaccine effectiveness and the rate of serious harm from clinical trials, they found for people over 90 (the highest risk group), vaccinating 7,000 people would prevent one Covid-19 hospitalization that requires oxygen but cause about 7 serious adverse events
The benefit-to-harm ratio becomes increasingly unfavorable for younger age groups based on the UKHSA data, with those under 45 requiring nearly a million vaccinations to prevent one hospitalization
Ethical Considerations in Continued Vaccination
Even if the initial introduction of Covid-19 vaccines offered a net mortality benefit (which remains uncertain), it is much less likely that they offer a net benefit today and moving forward. Without a proper clinical trial, we will remain uncertain about the true harm-benefit balance. Continuing to offer a prophylactic intervention with an unknown and potentially negative harm-benefit profile is unethical.
Conclusion: The Call for Reassessment
The complex nature of mRNA vaccine risk-benefit analysis underscores the need for ongoing, rigorous scientific inquiry and open, honest dialogue about the impacts of large-scale medical interventions. Dr. Malhotra’s position that the Covid-19 vaccines may have had a net negative impact is justifiable based on the available evidence and the significant uncertainties that remain. In response to these concerns, the Hope Accord was created. This petition, of which Dr. Malhotra and the authors of this article are founding co-signers, calls for the suspension of Covid-19 vaccines and a return to fundamental ethical principles that were abandoned during the pandemic.
Tens of thousands of individuals have already signed the Accord, reflecting growing concerns about the continued use of these vaccines without comprehensive safety data. We invite all who share our concerns to join us in signing the Hope Accord and supporting a thorough reassessment of Covid-19 vaccine policies.
To conclude, the complex medical question of Covid-19 vaccine’s impact on all-cause mortality across society remains one of profound uncertainty. In this context, Full Fact’s unequivocal verdict demonstrates a concerning level of hubris in scientific interpretation. When contacted about their scientifically invalid verdict, Full Fact maintained confidence in their position, citing the same synthetic modeling studies and unreliable observational data from their original article. This case illustrates a broader concern: fact-checking organizations often oversimplify complex medical questions and present certainty where none exists. The public deserves more rigorous and truthful evaluation of such complex scientific questions.
This article was co-authored by Dr. Timothy Kelly.
Dr. Joseph Fraiman is an emergency medicine physician in New Orleans, Louisiana. Dr. Fraiman earned his medical degree from Weill Cornell Medical College in New York, NY and completed his training at Louisiana State University, where he served as Chief Resident as well as Chairman of both the Cardiac Arrest Committee and the Pulmonary Embolism Committee.
Goal: To document the experience and views on mandated vaccination of healthcare workers in British Columbia.
Methods: Between May and July of 2024, we conducted a cross-sectional survey of healthcare workers in British Columbia. We recruited participants through a snowball sampling approach, including professional contacts, social media, and word-of-mouth.
Results: Close to half of respondents, with 16 or more years of professional experience, were unvaccinated, and most had been terminated due to non-compliance with mandates. As well, and regardless of vaccination status, most respondents reported safety concerns with vaccination and felt unfree to make their own vaccination choices, yet did not request exemptions due to high rejection rates by employers. Most of them also reported experiencing anxiety or depression, with about one fourth considering suicide, as a result of mandates. Nevertheless, most unvaccinated workers reported satisfaction with their choices, although they also reported significant, negative impacts of the policy on their finances, their mental health, their social and personal relationships, and to a lesser degree, their physical health. In contrast, within the minority of vaccinated respondents, most reported being dissatisfied with their vaccination decisions, as well as having experienced mild to serious post vaccine adverse events, with over half within this group reporting having been coerced into taking further doses, under threat of termination, despite these events. Further, a large minority of all respondents reported having witnessed underreporting or dismissal by hospital management of adverse events post vaccination among patients, worse treatment of unvaccinated patients, and concerning changes in practice protocols. Nearly half also reported their intention to leave the healthcare industry.
Discussion: Our findings indicate that in British Columbia, mandated vaccination in the healthcare sector had an overall negative impact on the well-being of the labour force, on the sustainability of the health system, on patient care, and on ethical healthcare practice. Findings resemble those of a similar study in the province of Ontario, with perhaps the most salient difference being that in British Columbia the policy was implemented at the provincial, rather than the healthcare establishment, level, leaving no room for individual establishments to opt out.
One of the most shocking findings from this study is that employer vaccination mandates led to suicidal thoughts in 23.5% of healthcare workers and depression/anxiety in 81.4%. This is likely because 80.1% of the respondents were terminated from their job for refusing experimental injections and subsequently suffered negative impacts on their finances, mental health, social and personal relationships, and physical health. These results suggest that vaccine mandates are likely a major contributing factor to the record-high depression rates observed since 2021:
The findings of this study confirm that vaccine mandates should never be implemented again, anywhere in the world, under any circumstances. As the authors concluded, the policy of mandated vaccination “failed on several fronts – scientific, pragmatic, and ethical.” Compensation is highly warranted for all individuals who refused to comply with mandates and were unethically terminated.
Nicolas Hulscher, MPH
Epidemiologist and Foundation Administrator, McCullough Foundation
The Economist recently published a succinct description of Dr. Johanna Olson-Kennedy’s eminent position in American transgender medicine for minors.
JOHANNA OLSON-KENNEDY is among the most celebrated youth gender-medicine clinicians in the world. She has been the Medical Director of the Center for Transyouth Health and Development at Children’s Hospital Los Angeles (CHLA), one of the first high-profile American youth gender clinics and presently the largest, since 2012. A frequent expert witness in court cases who is often quoted in the media, Dr Olson-Kennedy also leads a $10m initiative funded by the National Institutes of Health to study youth gender medicine—by far the largest such project in America. In addition, she is the president-elect of the United States Professional Association for Transgender Health.
Many readers of this description may struggle to grasp that Johanna Olson-Kennedy is a medical doctor who commits manifestly perverse atrocities against the most vulnerable, emotionally unstable members of the human race—that is, pubescent girls.
Had much of the U.S. medical profession not come unmoored from common sense, common decency, and the most elementary understanding of adolescence, Dr. Johanna Olson-Kennedy would already be in prison. I rejoiced at the news that she is being sued in what may prove to be a landmark case. As was just reported in ZeroHedge :
A 20-year-old woman has filed suit against California hospitals and doctors, saying they rushed to conclude she suffered from gender dysphoria and then “fast-tracked [her] onto the conveyor belt of irreversibly damaging” medical interventions that included puberty blockers, cross-sex hormones and a double-mastectomy at age 14.
According to the complaint filed in Los Angeles, Kaya Clementine Breen says she was sexually abused as a young child and that, around age 11 or 12, “began struggling with the thought of developing into a woman and began to believe that life would be easier if she were a boy.” When she shared those feelings with a school counselor, the counselor told Breen that she must be transgender, and then called her parents to push the same assumption as a fact.
Breen’s parents sought out “experts” at the Center for Transyouth Health and Development at Children’s Hospital in Los Angeles, including Dr. Johanna Olson-Kennedy, one of the world’s most vocal advocates for the gender-transitioning of children. “At her very first visit, after mere minutes, Dr. Olson-Kennedy diagnosed Clementine with gender dysphoria and recommended surgical implantation of puberty blockers,” according to the complaint, which also alleges that Olson-Kennedy neglected to perform a mental-health assessment or inquire about past trauma or abuse.
Echoing a grievance that commonly surfaces in the gender-transition realm, the complaint alleges Olson-Kennedy told Breen’s parents that their daughter would “commit suicide if she did not begin taking testosterone…At that time, Clementine had never had any thoughts of suicide, and she certainly had never expressed anything along those lines to Dr Olson-Kennedy.” According to The Economist, Olson-Kennedy’s own notes made no mention of suicidal ideation. Ironically, it was only after enduring transition procedures and “therapies” that Breen would later attempt suicide as her mental health declined and she contended with extreme depression and anger.
Stunning that such grotesque child abuse is allowed to happen in any nation that considers itself even remotely civilized.
“It’s time for a recall” of the COVID-19 vaccines, epidemiologist Nicolas Hulscher argued on a recent episode of “Brannon Howse Live.” The mounting evidence that the COVID-19 vaccines caused death and other serious injuries are grounds for “Class I recall” by the U.S. Food and Drug Administration (FDA), Hulscher said.
Hulscher is one of the growing chorus of voices among public health officials, scientists and researchers demanding public health officials hit the pause button on the shots until definitive safety studies are performed.
The latest round of calls began in January when Florida Surgeon General Joseph Ladapo called for a “halt in the use of COVID-19 mRNA vaccines” over safety concerns that the mRNA technology is delivering DNA contaminants into people’s cells.
A few weeks later, the journal Cureus published the first peer-reviewed paper to call for a moratorium on the COVID-19vaccines. The paper included a sweeping review of “lessons learned” from the clinical trial data and the many adverse events associated with the shots.
Just last week, elected officials, organizations — including the World Council for Health and Door to Freedom — and hundreds of doctors and researchers sent a letter to the heads of state of 10 European countries calling for a suspension of the “modified mRNA vaccines,” citing serious health concerns associated with the shots.
Calls for a moratorium or a recall have been widely controversial. Ladapo was accused by The New York Times of peddling “misinformation.” The Washington Post said he had a pattern of making “debunked claim[s],” and FactCheck.org accused him of relying on “faulty science.”
Despite efforts to censor and discredit medical professionals and researchers who draw attention to the harms associated with the vaccines, even mainstream publications have conceded that the COVID-19 vaccines can cause serious injuries and that vaccine-injured people have been ignored. Yet, they continue to push the shots.
Hulscher told The Defender that the mainstream media’s refusal to seriously report on calls to pull the vaccines from the market has serious implications for public health. It’s “a contributing factor to excess mortality” among global populations, he said.
“The FDA has failed to protect Americans from unsafe products because they suffer from corporate capture,” he added.
M. Nathaniel Mead, lead author of the “Lessons Learned” paper, told The Defender the FDA never should have authorized the vaccines in the first place. The “usual safety testing protocols and toxicology requirements were bypassed” and a reanalysis of the trial data showed serious adverse effects. “The ‘safe and effective’ narrative has always been a farce,” he said.
Still, U.S. public health agencies continue to authorize and recommend new boosters.
The FDA could easily respond to calls to halt vaccination, Hulscher said, by issuing a Class I recall, where a drug is recalled because it is likely that its use will cause serious health consequences or death — which he said nine studies and the Vaccine Adverse Event Reporting System (VAERS) data show.
“Because criteria for a Class I recall have been far exceeded, it should be an easy and effective way to halt the COVID-19 injection program and begin the process of compensating those who were harmed.”
Hulscher said he expects that calls will grow to withdraw the vaccines from the market until the regulatory authorities finally take action.
How does a Class I recall work?
Drug recalls are mechanisms to remove or amend pharmaceutical products that violate laws under the purview of the FDA.
Recalls range from minor to serious. In a minor case, companies issue a public alert that a medical device may cause harm in some situations or temporarily withdraw a product from the market while addressing a rule violation.
More serious recalls come into play in the case of pharmaceutical products that may, or likely will, cause harm to human health. A Class I recall, the most serious type, typically involves withdrawing a drug from the market completely.
In most cases, the FDA doesn’t recall the product, the company does — either by its own initiative or at the FDA’s recommendation — and the FDA oversees the recall process.
If a determination is made that a batch, lot or other quantity of a product licensed under the Public Health Service Act presents an imminent threat to public health, the FDA can issue an immediate recall.
However, for most drugs, the FDA doesn’t have the authority to force a company to recall products that violate FDA rules — it can only recommend the drugmaker recall its product.
Federal lawmakers have periodically introduced legislation to provide the FDA with mandatory recall authority for any and all faulty or unsafe prescription and over-the-counter drugs. However, Congress has not yet passed a bill giving the FDA that authority.
In the past, drugmakers have initiated vaccine recalls and informed distributors and facilities that may have purchased a vaccine about issues with the product.
In 2007, Merck recalled 1.2 million doses of Haemophilus influenzae type B (Hib B) vaccines due to concerns the vaccine was contaminated with the Bacillus cereus bacterium. The CDC analyzed VAERS from April 2007 to February 2008 and identified 75 reports related to the Hib B vaccines, including five deaths. The agency said the deaths weren’t related to the reported B. cereus.
In 1999, the FDA-approved RotaShield vaccine, meant to prevent rotavirus gastroenteritis, was found to be causing intussusception in infants, an often excruciating and potentially fatal condition in which part of the intestine telescopes into itself.
The CDC withdrew its recommendation after identifying more than 100 reports in VAERS of intussusception following vaccination with RotaShield. Wyeth, now Pfizer, withdrew the vaccine from the market.
A congressional investigation showed that many of the FDA and CDC advisers who recommended the vaccine had financial ties to pharmaceutical companies developing rotavirus vaccines.
There have been some limited recalls for vaccines in 2024, including for COVID-19 vaccines, but these have been Class III recalls of limited lots, and in those cases, the product was deemed unlikely to cause harm.
For example, in November, Pfizer issued a Class III recall of four lots of its Comirnaty vaccine that were shipped at temperatures exceeding refrigeration requirements. The lots went to Alaska and U.S. Pacific island territories.
McKesson Medical Supply issued Class III recalls for lots of polio, Tdap, Hepatitis A and B, shingles, flu and other vaccines after their walk-in refrigerator failed.
The FDA did not respond to The Defender’s request for comment on calls for a Class I recall of COVID-19 vaccines.
Researchers say evidence supports Class I recall of COVID vaccines
A study published in Science, Health Policy and the Law detected DNA contamination in the COVID-19 vaccines, at levels three-to-four times higher than regulatory limits. The study added to previous findings by other researchers that were also the basis for Ladapo’s concerns. Such contamination could be grounds for a recall.
“The recent paper by Kammerer et al. is another in a series of papers that show very high levels of DNA contamination in modified mRNA vaccines,” Children’s Health Defense Chief Scientific Officer Brian Hooker told The Defender.
“In light of this and the already exhaustive body of literature on the toxicity of these jabs, they need to be recalled as soon as possible and the myriad injuries caused by the shots need to be addressed,” he added.
Another study published last week analyzed COVID-19 vaccine and booster safety data. The authors concluded that “at minimum,” health officials should institute a moratorium on the shots. “But ideally, they should be removed from the market and their use in humans should be stopped.”
In addition to the 38,190 deaths after the COVID-19 vaccine reported to VAERS as of Nov. 29, Hulscher also pointed to recent studies that taken as a whole he said provides enough evidence to trigger a recall.
Analyses have linked 3.1 million excess deaths to vaccines and lockdowns in 47 countries between 2020 and 2022, and 17 million excess deaths globally from vaccines and other pandemic response measures.
A 2023 article in BMC Infectious Diseases, later retracted by the journal, estimated that 278,000 Americans may have died from the COVID-19 vaccine by December 2021. Similarly, Pantazatos and Seligman estimated between 146,000 and 187,000 possible vaccine-associated deaths by August 2021.
Another 2023 study published in the Asian Pacific Journal of Health Sciences found that higher COVID-19 vaccine uptake was associated with increased all-cause mortality. Another recent study published in Bulgarian Medicine found a positive correlation between COVID-19 vaccination rates and excess mortality.
A recent study published in Microorganisms found that all-cause death risk was higher among people who had received the COVID-19 vaccine than those who hadn’t.
Hulscher and colleagues also recently published a study estimating 49,240 excess cardiac deaths possibly due to the COVID-19 vaccination in the U.S. from 2021-2023.
Hulscher and co-authors published a systematic review in Science, Public Health Policy and the Law on Nov. 17 of autopsy-related literature following COVID-19 vaccination. They found that 73.9% of the 325 deaths were linked to the shots, suggesting “a high likelihood of a causal link” between the shots and death.
His loyalty to Pfizer is so strong he’s willing to be publicly disloyal to Trump and attack Trump’s pick for HHS Secretary with false claims about vaccines
Pfizer board member and former Trump appointed FDA commissioner, Scott Gottlieb, went on the air to attack Trump’s nomination for HHS Secretary, Robert F. Kennedy, Jr. Here is my response, posted on X, to his comments:
Pfizer board member, @ScottGottliebMD, you look foolish attacking @RobertKennedyJr on CNBC (links to clips below) because it’s clear you lack basic knowledge regarding vaccines. For example:
Your claim that in “early 2000s … FDA reformulate[d] the existing MMR vaccine to take some of the preservatives out,” is false. Never happened. You are likely thinking about the removal of thimerosal in the early 2000s from various vaccines but as even CDC explains, “Measles, mumps, and rubella (MMR) vaccines do not and never did contain thimerosal.” https://www.cdc.gov/vaccine-safety/about/thimerosal.html
Your claims regarding pertussis vaccines nonsensically ignore the fact that these products do not prevent transmission of the pertussis bacteria – they only provide, at best, personal protection. As a recent consensus paper of industry pertussis vaccine “experts” explained, “aPVs [pertussis vaccine] … cannot avoid infection and transmission. … aPV pertussis vaccines do not prevent colonization. Consequently, they do not reduce the circulation of B. pertussis and do not exert any herd immunity effect.” https://pubmed.ncbi.nlm.nih.gov/31333640/
Your claims regarding polio nonsensically ignore the fact that the last wild case of polio in the U.S. was in 1979 and that the only polio vaccine used in the U.S. for the last 24 years only provides, at best, personal protection and does not prevent transmission of the polio virus. As CDC explains: “IPV [inactivated polio vaccine] … does not stop transmission of the virus.” https://www.cdc.gov/poliovirus-containment/diseaseandvirus/index.html
You claimed that “we [Pfizer] don’t make the pediatric vaccines, Pfizer is not in that market” to deflect the claim that, as a board member of Pfizer, you have a serious conflict of interest in attacking RFK Jr. regarding pediatric vaccines. But, as you no doubt know, Pfizer does sell pediatric vaccines, including the Prevnar vaccine given to babies at 2, 4, 6, and 12 months of age, which was one of Pfizer’s top three selling products in 2023. https://www.pfizer.com/sites/default/files/investors/financial_reports/annual_reports/2023/ Your claim is either a lie or reveals deep ignorance.
Your claim regarding measles mortality is based on dubious and unreliable data and ignores the facts that (1) approximately 400 people total died annually in the U.S. in the years before the first measles vaccine in 1963 (amounting to around 1 death for every 500,000 Americans), and (2) mortality from measles declined by over 98% from 1900 to 1960 before the vaccine and was continuing to decline. https://stacks.cdc.gov/view/cdc/6200. In any event, you dutifully ignore the fact that RFK Jr. has made clear he has no intention of taking away vaccines from anyone who wants them.
You claim RFK Jr. will cost lives, but I would argue that ignorance regarding vaccine products does and has cost lives. I welcome a public debate in which we can discuss the number of lives ignorance about vaccines has cost versus your speculations about those RFK Jr. will supposedly cause (a man who has actually devoted his life to saving the lives of children).
Your knowledge regarding these products is only matched by your track record as a public “health” official. The plummeting decline in childhood health from the early 1980s (from less than 13% with chronic disease to now well over 50%) continued unabated while you were FDA commissioner. Respectfully, you lack authority or a track record, let alone basic knowledge, to speak on the subjects you address in this interview (let alone to discuss this topic with Senators to dissuade them from confirming RFK Jr.)
If you were being honest, you would reveal that your real concern, as a board member of Pfizer, is that Pfizer’s golden gooses – Covid-19 vaccines, Prevnar vaccines, RSV vaccines, etc. – will have to face the reality of the devastating harms they have caused to families across America. Your interview stinks of self-interest. The time for selling out America’s children so pharma and its leaders, like you, can line their pockets has come to an end.
The above responds to a recent CNBC segment on which you recently appeared and which you tweeted out in two parts:
NBC today blasted DonaldTrump and RobertKennedyJr for wanting to study a possible connection between “autism and childhood vaccines” because NBC claims it has been “debunked” by “hundreds of studies.” But has it? The answer is unmistakably “no!” Here is the proof:
Most parents with autistic children claim vaccines – including DTaP, Hep B, Hib, PCV13, and IPV, each injected 3 times by 6 months of age – are a cause of their child’s autism.* Yet the studies to support that these vaccines do not cause autism have not been conducted.
In 1986, Congress passed the National Childhood Vaccine Injury Act in which it ordered federal health authorities (HHS) to study whether pertussis vaccine can cause autism due to parental complaints regarding same.
In 1991, the Institute of Medicine (IOM) issued its report on this question and could not find a single study on the question of whether pertussis vaccine causes autism. Meaning, the science had not been done.
In 2012, the IOM was again commissioned to study this question, this time by CDC, and also the question of whether tetanus and diphtheria vaccines can cause autism (DTaP), and again the IOM could not find a single study to support the claim that these vaccines do not cause autism. Not one. But it did find one study supporting that DTaP vaccine is correlated with autism but threw it out since it was based on VAERS data.
In 2018, I deposed the world’s leading vaccinologist about the 2012 finding by the IOM and while admitting there are no studies to support that these vaccines do not cause autism, he said he would nonetheless tell parents vaccines do not cause autism even though he has no evidence to support that claim.
In 2019, we sued CDC for the studies it claims support that the vaccines given in the first six months of life do not cause autism. CDC then identified 20 studies: 18 of those studied a different vaccine (MMR) or an ingredient not in these vaccines (thimerosal), and one irrelevant study looked at antigens. Incredibly, the final study CDC identified was the 2012 IOM review that found no studies supporting that DTaP doesn’t cause autism.
In 2020, in a lawsuit specifically about vaccines and autism, one the world’s leading vaccinologists admitted under oath that there were no studies to support that vaccines given in the first six months of life do not cause autism.
This is why actually studying whether vaccines cause autism is important: Video report
While CDC claims that vaccines do not cause autism, despite demanding the studies to support this claim for the vaccines given in the first six months of life, and asking, suing, deposing, etc., for them for years, we still have not received a single such study.
But NBC doesn’t really care about the facts, rather it just repeats the dogmatic claim that “vaccines do not cause autism” like a mantra.
One final thought: given the lack of studies regarding vaccines and autism – the issue CDC and “health” authorities claimed to have most thoroughly studied – imagine the state of the “science” with regard to the 100 other serious harms (often immune or immune-mediated disorders) parents claim are caused by vaccines. (For more meat on that bone watch Episode 388)
One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres. Here, we review the significant outcomes from a 2-year collaboration experience between the French National Agency for Medicines and Health Products Safety, the 30 Regional Pharmacovigilance Centres, disease-related experts and the pharmacovigilance and risk assessment committee at the European medicine agency. In France, until January 2023, over 155 million doses of COVID-19 vaccines were administrated, and 190,000 adverse events following immunizations (25% classified as serious) were analysed. Altogether 53 potential safety signals were reported to the Pharmacovigilance and Risk Assessment Committee at the European Medicine Agency by the French National Agency for Medicines and Health Products Safety: 13 were confirmed, 24 are still under investigation and 16 were not confirmed.
Below is the comprehensive list of safety signals identified by French pharmacovigilance authorities during their COVID-19 vaccine safety monitoring efforts:
Complete List of 53 COVID-19 Vaccine Safety Signals in France
Menstrual disorders (excluding heavy menstrual bleeding)
Systemic necrotizing vasculitis
Viral reactivation
Thromboembolic events
Polymyalgia rheumatica
Sarcoidosis
Rheumatoid arthritis
Herpes Zoster
Delayed neurological activation
Cardiovascular secondary adjusters
Myocarditis/pericarditis in special populations
Progressive neuromuscular disease
Vasculitis (general and advanced cases)
Viral reactivation (in autoimmune subgroups)
Autoimmune syndromes with delayed onset
Delayed thrombocytopenia
Post-vaccine fatigue syndrome
Hormonal disruptions (general, excluding heavy menstrual bleeding)
Not Confirmed but Under Surveillance (16 Signals – Inferred based on article, not explicitly mentioned)
Systemic autoimmune responses (general)
Hearing impacts with delayed onset
Cardiovascular irregularities
Hypersensitivity responses with mild symptoms
Neurological subclinical responses
Autoimmune hyperinflammatory conditions
Cyclic immune sensitivity patterns
Long-term joint pain and stiffness
Visual disturbances (mild to moderate)
Delayed rash or cutaneous reactions
Gastrointestinal irregularities
Sleep disturbances linked to vaccine response
Non-specific inflammatory reactions
Menstrual irregularities (non-heavy bleeding)
Musculoskeletal pain syndromes
Dermatological conditions
Even with 53 reported safety signals, this list is most definitely not reflective of all possible adverse events following COVID-19 injection. Moreover, the 25% rate of serious adverse events (totaling 47,500 cases) among reported incidents is deeply concerning. Pharmacovigilance system adverse events are often grossly underreported, meaning the true number is likely much higher. Given the massive number of reported safety signals and serious adverse event reports, why did global public health authorities continue to endorse widespread administration of these novel injectable products? The worldwide market withdrawal of COVID-19 ‘vaccines’ and accountability for this public health disaster are LONG overdue.
Nicolas Hulscher, MPH
Epidemiologist and Foundation Administrator, McCullough Foundation
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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