Sanofi Didn’t Follow Protocol for Clinical Trial in Which Infant Died

Sanofi shut down its RSV vaccine trial for infants and toddlers in 2024 after a baby died. It was later determined that the baby had an underlying congenital heart defect, which should have disqualified the infant from participating in the trial.

Now, a newly obtained letter shows the company paused the trial “to re-educate all participating sites and investigators” on the criteria they should use to judge who should or shouldn’t be allowed to participate in the trial, and to “reiterate the need to assess for chronic illnesses” that would make an infant or toddler ineligible to participate in a clinical trial.

The letter — obtained through a Freedom of Information (FOI) request by British general practitioner and RSV vaccine expert Dr. Peter Selley — sheds new light on the infant death and trial pause first reported by The Defender.

The infant’s death constituted a “serious adverse event” that triggered the halt.

A Sanofi spokesperson last month confirmed the death and told The Defender that the baby had underlying congenital heart disease. The company’s analysis — supported by the independent data monitoring committee — the spokesperson said, concluded the experimental vaccine was not the “underlying cause of the event.”

Research published in the Pediatric Infectious Disease Journal indicates that most children who die from respiratory syncytial virus, or RSV, have comorbidities such as congenital heart or lung disease.

Congenital disorders should have excluded babies from the study, and participants should have been assessed for preexisting conditions, according to the clinical trial’s exclusion criteria.

“Given that they stopped the trial to ‘re-educate’ investigators about inclusion and exclusion criteria, it suggests that the trial protocol was not being followed in at least one of the trial sites,” Selley told The Defender.

Sanofi told The Defender that when the infant with an undiagnosed underlying heart condition died after receiving the experimental vaccine, the company proactively informed and worked closely with the independent data monitoring committee (IDMC) and health authorities to address the issue.

He said the U.S. Food and Drug Administration (FDA) put the trial on a clinical hold and the company worked “to amend the Phase 3 protocol, adjust and clarify screening procedures and inclusion criteria, and re-educate all participating sites and investigators.”

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30 Dead, 17 Fatal Crashes, and a Judge Tells DHS to Wait

Thirty people were killed in 17 crashes in 2025 involving what the left’s dictionary calls “non-domiciled commercial drivers” who, under the Trump administration’s current rule, would no longer qualify for those licenses.

The issue isn’t foreign CDL drivers; plenty of lawful immigrants and foreign-born drivers safely operate commercial trucks daily. The issue is whether somebody who can’t adequately read road signs, understand warnings, communicate with police, or follow instructions in English should be behind the wheel of an 80,000-pound commercial vehicle on an American highway.

That’s a safety standard, not a nationality test.

When crashes expose drivers who apparently couldn’t meet that basic standard, the question becomes unavoidable: Who licensed them, who failed to catch it, and why were they still on the road?

Senior U.S. District Judge Anthony Trenga put DHS’s access to roughly 17 million commercial driver records on hold Friday. His administrative stay is temporary, and he hasn’t ruled the subpoena unlawful

DHS must file its opposition Monday, the states reply Wednesday, and Trenga has scheduled a hearing for Thursday.

DHS wants five years of records from the Commercial Driver’s License Information System, including names, birth dates, license numbers, states of record, and Social Security numbers. The subpoena says the information would be used to investigate illegal practices at CDL schools, criminal fraud involving CDLs issued to illegal aliens, and civil immigration enforcement.

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Nearly Half Of NYC Homeless Deaths Due To Drugs Or Alcohol: Study

Nearly half of all deaths among New York City’s homeless population in the most recent fiscal year were connected to drug use or alcohol abuse, according to a new city report.

Of the 634 people experiencing homelessness who died between July 1, 2024, and June 30, 2025, 285 lost their lives to drug addiction, overdoses, or alcoholism. The figures come from the annual mortality report jointly issued by the city’s Department of Health and Mental Hygiene and the Department of Social Services/Homeless Services.

Drug-related causes alone accounted for 251 deaths, or 40 percent of the total – still the leading cause of death among this population. Alcohol misuse or dependence contributed another 34 deaths (5 percent). Together, substance-related deaths made up roughly 45 percent of the total, the NY Post reports.

The report covers deaths that occurred in temporary shelters, on the streets, in the subway system, in abandoned buildings, and in other locations. Fifty-two percent of those who died were classified as unsheltered; 48 percent were living in a homeless facility at the time of death. Most (58 percent) died in a hospital. Among unsheltered individuals, 22 percent died outdoors.

Other leading causes of death included heart disease (78 deaths, 12 percent), accidents excluding drug overdoses (60 deaths, 9 percent), and cancer (23 deaths, 4 percent). Additional figures included 18 suicides, 15 deaths from hypothermia or cold exposure, 15 subway-related accidents, 14 motor-vehicle accidents, and 11 homicides. A small number of deaths involved toxic substances, heat exposure, or falls. In ten cases, the manner of death could not be determined.

The overall number of deaths declined nearly 18 percent from the previous year, when 770 people experiencing homelessness died. Drug-related deaths specifically fell 28 percent, from 348 in fiscal year 2024 to 251 in fiscal year 2025. Despite the drop, substance use remained the dominant cause of mortality, consistent with both citywide and national patterns.

City officials noted that the true toll is likely higher. Thousands of migrants housed in temporary facilities operated by other agencies during the border crisis were not fully included in the data-matching process, meaning some deaths may have gone uncounted as homeless fatalities.

The report is the 20th in the annual series required by law. Authors said the data help identify pressing health risks for a highly vulnerable population that faces elevated rates of poorly controlled physical and mental health conditions, compounded by poverty, housing instability, and other social stressors.

As of early August 2026, the city’s shelter system housed roughly 83,200 people – down from a peak above 100,000 during the height of the migrant influx. The city has extended a $1.86 billion contract to continue using commercial hotels as emergency shelter for the next three years.

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Fauci privately estimated COVID-19 death rate far lower than he gave Congress, diary shows

r. Anthony Fauci privately believed that the death rate of the COVID-19 was much lower than he told Congress just one month later, according to a record kept by the health official from February 2020. 

The diary entry was made public by Sen. Rand Paul, Chairman of the Senate Committee on Homeland Security and Government Affairs, prior to Dr. Fauci’s testimony earlier this week. During his appearance, Fauci refused to answer any substantive questions and cited the 5th Amendment more than 110 times. 

During his time as the leading government health official during the COVID-19 pandemic, Fauci kept a meticulous record of his meetings, phone calls, and other day-to-day activities. 

Fauci has faced scrutiny from Republicans for years for his role in the early response to the COVID-19 pandemic as a member of the White House Coronavirus Task Force that included recommendations for school closures and social distancing.

On March 11, 2020, as the coronavirus spread beyond China to Europe and the United States, Fauci told the House Oversight Committee that he estimated COVID-19’s fatality at 3% and told lawmakers it was much more deadly than the seasonal flu. 

The “case fatality rate” was “more like 0.2-0.3%”, Fauci’s personal notes reveal

“The stated mortality over all of this when you look at all the data, including China is about three percent. It first started off as two and three,” Fauci told the committee at the time. 

“I think if you count all the cases of minimally symptomatic or asymptomatic infection, that probably brings the mortality rate down to somewhere around one percent, which means it is 10 times more lethal than the seasonal flu,” Fauci continued. “I think that is something that people can get their arms around and understand.”

But, in a diary entry from just weeks before his testimony on Capitol Hill, Fauci memorialized a phone call with former Centers for Disease Control and Prevention Director Tom Frieden in which both agreed the real “case fatality rate” was “more like 0.2-0.3%.”

“Tom Frieden called me this AM and we discussed various aspects of the outbreak. He and I are on the same page in thinking tht [sic] this is acting like a bad influenza in its transmissibility and that the denominator is much greater than 34,867 (above) making the case fatality rate (CFR) more like 0.2-0.3 % rather than 2.0%,” Fauci wrote in the February 8 diary entry. 

You can read Fauci’s notes below: 

File

2026.07.24_Tonys-Diary-Package.pdf

“Stirring up fear and anxiety”

Dr. Harvey Risch, Chairman of the Trump administration’s Cancer Panel at the Department of Health and Human Services, told Just the News that Fauci’s behavior is an example of the “gigantic hubris and toxic paternalism” in the public health industry. 

“The fact that he knew this and couldn’t say the truth in public means he had other interests to pursue,” Risch said on the Just the News, No Noise TV show.  

“And, I think the worst one of all the ones […] was his estimate of the fatality rate of COVID that he was saying publicly it was one to 2%, stirring up fear and anxiety, while privately he was writing that it was a 10th of a percent, which is like a bad flu and would not have generated the same anxiety in the general public had he spoken the truth,” Risch added. 

The more than 1,141 pages of records released by the Senate committee earlier this week provide the most detailed glimpse into Dr. Fauci’s experience of the COVID-19 pandemic and the government’s response to it. 

The pages show, for example, how Fauci appeared to work to squash the lab leak theory, even though he, nor the vast majority of the scientists he consulted, accepted the Chinese “wet market” theory of COVID-19 origin in early 2020. 

Fauci’s alleged Feb. 1, 2020 personal notes recount the phone call that eventually produced the Proximal Origin paper, which concluded natural origin was the only credible explanation for COVID’s emergence, Just the News previously reported

Only two of a dozen scientists on the call were “sure that this could occur naturally, and we should not waste our time and divert effort to pursue this,” Fauci said, referring to the possibility that the coronavirus’ unusual ability to easily infect humans was engineered.

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Sen. Ron Johnson Unloads Devastating Safety Data on Fauci — Says COVID Shot Logged Nearly 7,000 Death Reports Per Year While FDA Ignored Warning Signs and Pushed Remdesivir

Sen. Ron Johnson (R-WI) dropped another bombshell during Wednesday’s explosive Senate hearing with Dr. Anthony Fauci, confronting the former COVID czar with adverse event data that he argued should have triggered urgent scrutiny years ago—but instead was ignored while federal health agencies relentlessly promoted COVID vaccines and Remdesivir.

Johnson’s latest exchange came after he previously confronted Fauci with stacks of studies on ivermectin and questioned why federal officials dismissed evidence supporting alternative treatments before Fauci invoked his Fifth Amendment right against self-incrimination during the hearing.

The Wisconsin senator displayed comparative adverse-event figures during the hearing, arguing they represented safety signals that federal regulators refused to adequately investigate.

“These are averages. Again, it doesn’t prove causation, but there’s correlation. It’s there. It’s there for a safety signal,” Johnson said.

The chart, titled “Drug Adverse Event Comparison” and labeled “FDA and CDC Data: Worldwide,” compared adverse event reports, total reported deaths, and average deaths per year across multiple products.

According to the chart presented by Johnson:

  • Ivermectin (30 years, 1996–2026): 5,127 adverse events, 518 deaths, averaging 17 deaths per year.
  • Hydroxychloroquine (HCQ) (38 years, 1988–2026): 37,270 adverse events, 5,404 deaths, averaging 142 deaths per year.
  • Flu vaccines (36 years, 1990–2026): 243,335 adverse events, 2,770 deaths, averaging 77 deaths per year.
  • Dexamethasone (57 years, 1969–2026): 143,017 adverse events, 25,589 deaths, averaging 448 deaths per year.
  • Tylenol (57 years, 1969–2026): 184,186 adverse events, 42,627 deaths, averaging 747 deaths per year.
  • Remdesivir (69 months): 10,657 adverse events, 2,751 deaths, averaging 546 deaths per year.
  • COVID-19 vaccines (68 months): 1,677,227 adverse events, 39,182 deaths, averaging 6,922 deaths per year.

The chart also highlighted that 9,342 reported deaths occurred on days 0, 1, or 2 following COVID-19 vaccination.

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Czech data shows that those who got the Moderna vaccine died more

For the first time, I show the directly standardized survival curves for each 5 year age group in the Czech Republic using the publicly released record-level data.

This data consistently shows the people who got the Moderna vaccine were much more likely to die than those of the same age who got the Pfizer shot. The relative risk (RR) was >1.5 for those under age 60 which is a huge difference.

The comorbidity distribution for both groups of a given age range was very similar (SMD=.05)

This isn’t because Pfizer is more protective of a COVID death because the differences were not specific to COVID periods (and were too large to be explained by effectiveness differences).

There are two remaining explanations:

  1. The Moderna vaccine was more deadly
  2. There was a systematic distribution of vaccines in Czech Republic that no matter what age you were, if you were more likely to die, you were given the Moderna shots.

Explanation is 2 is much less likely because there was no systematic bias in vaccine distribution by brand, and even if there were, the fact that the DCCI distributions were similar and that the younger you were, the more pronounced the effect, would be unusual since 45 year old people are not concentrated in elderly homes and hospital beds.

So the most likely explanation is Moderna was more deadly.

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Remains of 22 more babies increases total to 99 found at Ireland site: authorities

The remains of 22 more babies were recovered from the site of a former institution for unmarried mothers and their children in Ireland, bringing the total number of bodies found during an ongoing excavation to 99, authorities announced.

The Office of the Director of Authorized Intervention at Tuam (ODAIT) on Wednesday said the discoveries were made at the site known as the former Mother and Baby Institution, which was operated by the Bon Secours Sisters, an order of Catholic nuns, from 1925 to 1961.

The remains were found in coffins in an area identified in historical records as a burial ground, but later covered with asphalt and gravel and used as a driveway.

“As detailed in previous updates, the evidence ODAIT has recovered is consistent with this area being part of a burial ground from the time of the operation of the Mother and Baby Institution and it falls within an area identified in historical documents as a ‘burial ground,'” ODAIT noted in a news release.

“This location was previously covered with bitumen and gravel and used for vehicular access, according to ODAIT. There were no surface markers to indicate the presence of burials.”

ODAIT said the remains of 77 babies were previous recovered from the area “and earlier historic burials were identified beneath these.”

The recovery effort began in 2025 after years of investigations into the institution. People reported that historian Catherine Corless uncovered records showing 796 infants and young children died while the home was in operation, with many of the children having no recorded burial sites.

A previous excavation confirmed human remains beneath the property, prompting the Irish government to authorize a full forensic excavation.

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The Official Louisiana State Data Has No Other Explanation: US Childhood Vaccines Are Increasing Infant Mortality

Executive summary

This is it. This is the big one. Finally.

This is the story of the most damaging childhood vaccine study ever done.

I asked all four major AI engines to predict the outcome before showing them the results. All four said the same thing: the OR will be <1 and there will be minimal sex differences.

The actual result: OR >1 in 54/55 subgroup analyses and massive sex differences.

You would simply never see these results if the childhood vaccines were safe.

Nobody can explain the relatively higher deaths in the vaccinated cohorts if they were not caused by the vaccines. They all try to deceive you into believing the study methodology is subject to confounders and should be considered unreliable.

There are 3 biases that impact this study:

  1. Selection bias: The healthy vaccinee effect moves OR < 1 so that doesn’t explain the signal.
  2. Immortal time bias: This was caused by requiring everyone to be vaccinated before they die. Thus, if all kids are never vaccinated <60 days, then the unvaxxed group cannot die until they’ve been vaccinated. This was a big oversight in the paper. It might move OR > 1 depending on the data. If most all kids had their first vaccine < day 60 like their HepB vaccinate at birth, then this bias makes no difference. I’ve made the study authors aware of this. The limitation can be corrected by requiring a vaccination record match found prior to the landmark date (day 90).
  3. Right truncation bias: This affects only the Vaxelis group because Vaxelis was only available starting in 2021 so these recipients had less time to die than the unvaccinated group. This inflates the OR for the vaccinated group, but even after correction, it’s still a problem. I’ve made the study authors aware of this.

All Bradford Hill causality criteria are satisfied. So this isn’t just correlation. This is CAUSATION. The sex signal is not subject to any of the biases identified above.

This means that the recommended vaccines for 2 month old kids are unsafe.

There is no credible way to attack this study.

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What a Landmark Case in Britain Could Mean for Mother Charged in Idaho Twins’ Deaths

When Angela Cannings’ child died in 1989, doctors concluded the 13-week-old baby girl tragically succumbed to sudden infant death syndrome (SIDS).

By the time two more infants — one in 1991, the other in 1999 — died, suspicion replaced sympathy.

Prosecutors alleged the English mother had suffocated her two sons. To make their case, they relied on prominent pediatric experts who testified that multiple unexplained infant deaths in one family were extraordinarily unlikely to occur naturally.

In 2002, a jury convicted Cannings of murder, and she was sentenced to life in prison.

Less than two years later, the England and Wales Court of Appeal overturned the convictions in a decision that fundamentally changed how British courts view expert medical testimony in unexplained child death cases.

Ruling continues to influence legal discussion decades later

The ruling in Cannings’ case continues to influence legal discussions more than two decades later because it established an enduring principle. Namely, when respected medical experts fundamentally disagree about the cause of a child’s death, and there is no compelling independent evidence of homicide, criminal convictions should not rest on disputed scientific opinion alone.

The Court of Appeal had ruled prosecutors should not proceed when reputable experts disagree about the cause of death and there is no other compelling evidence.

That principle has resurfaced in legal commentary as prosecutors in Idaho pursue murder charges against Andrea Shaw, accused of killing her 18-month-old twin toddlers.

The 23-year-old mother was arrested more than a year after her fraternal twins, Dallas and Tyson, were found dead in their home on May 1, 2025, eight days after receiving their 18-month vaccines.

Shaw spoke with CHD.TV days after the tragic 2025 incident, saying at the 18-month mark, the twins received their hepatitis ADTaP and flu shots. Shaw said she told the pediatrician she was concerned about the flu shot because there was a history of adverse reactions to the vaccine on the father’s side of the family. However, the doctor assured her it was safe for the twins.

Within 24 hours, Shaw took the twins to the emergency room after they both became lethargic, their lips turned blue and they experienced digestive issues. Medical records confirm they were diagnosed with “post-immunization reaction.”

After administering Tylenol and observing the twins as they ate popsicles, doctors sent them home. Shaw told CHD.TV that days later, she discovered both children dead in their beds. “They looked as if they had gone in their sleep,” she said.

Shaw pleaded not guilty, and her attorney said the children died from medical complications rather than homicide. Prosecutors contend the twins were intentionally suffocated. On Tuesday, a district judge in Payette County revoked Shaw’s $2 million bail.

Shaw’s next court date is scheduled for August 18.

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If a SIDS-vaccine study offends, remove it

In 2021 Toxicology Reports published Neil Miller’s results of his examination of VAERS reports of 2,605 SIDS deaths between 1990 and 2019:

The peer-reviewed paper found that 75% of SIDS reports occurred within seven days of vaccination, with the highest number on day two. [snip] The journal removed the paper April 9, 2026, citing “serious methodological flaws” and “potential implications for medical practice.” Miller said the journal never specified what those flaws were, despite repeated requests.

Sen. Ron Johnson (R-Wis.) wrote a letter on June 29 demanding that “Toxicology Reports and its parent company Elsevier release all records related to the decision to remove the paper. HHS Secretary Robert F. Kennedy Jr. HHS also wrote to the journal June 11 seeking clarification.”

Neil Miller is careful to say that his paper correlating vaccines with SIDS does not prove causation. But reclassifying ICD codes to remove vaccine-related deaths and purging papers that expose shocking statistics to the contrary smacks of the deliberate suppression of information unfavorable to the vaccine industry.

This is not to damn vaccines: in the first half of the 20th century alone, smallpox is credited with killing 254 million people. Vaccines eliminated that disease. Although tuberculosis can be treated by medicine, the scourge of that devastating disease was largely vanquished by vaccines.

Multi-billion-dollar industries engender powerful — some may say insurmountable — incentives to grow and continue to grow, continuously. The vaccine industry is no exception.

The CDC maintains that children need vaccines starting within 24 hours of birth through age 18, comprising approximately 15-17 vaccines across 26-30 doses. The CDC fails the public when they create the impression of stacking the deck in favor of the industry by “reclassifying” or withholding contradictory information. Absence of absolute proof of harm is no excuse when the degree of safety remains unproven. Parents are entitled to access to all available information regarding the risks as well as the benefits of vaccines.

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