[1] Textbook: Applied Statistics: From Bivariate Through Multivariate Techniques. By Rebecca M. Warner. Sage Publications, 2008.

Page 5:

Researchers in the behavioral and social sciences almost always want to make inferences beyond their samples; they hope that the attitudes or behaviors that they find in small groups of college students who actually participate in their studies will provide evidence about attitudes or behaviors in broader populations in the world outside the laboratory. Thus, almost all the statistics reported in journal articles are inferential statistics

However, in many types of research (such as experiments and small-scale surveys in psychology, education, and medicine), it is not practical to obtain random samples from the entire population of the country. Instead, researchers in these disciplines often use convenience samples when they conduct small-scale studies. …

When researchers obtain information about behavior from convenience samples, they cannot confidently use their results to make inferences about the responses of an actual, well-defined population.

Page 6:

Generalization of results beyond the sample to make inferences about a broader population is always risky, so researchers should be cautious in making generalizations. … It could be misleading, however, to generalize the results of the study to children or to older adults. …

To summarize, when a study uses data from a convenience sample, the researcher should clearly state that the nature of the sample limits the potential generalizability of the results.

It would be questionable to generalize about response to caffeine for populations that have drastically different characteristics from the members of the sample….

[2] Book: Multiple Regression: A Primer. By Paul D. Allison. Pine Forge Press, 1998. Preface. <us.sagepub.com>

Page 9: “The most desirable data come from a probability sample from some well-defined population…. In practice, people often use whatever cases happen to be available. … Although it is acceptable to use such ‘convenience samples,’ you must be very cautious in generalizing the results to other populations.”

[3] Article: “Sexual Identity, Sex of Sexual Contacts, and Health-Risk Behaviors Among Students in Grades 9–12 — Youth Risk Behavior Surveillance, Selected Sites, United States, 2001–2009.” By Laura Kann and others. U.S. Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, June 10, 2011. <www.cdc.gov>

Page 43: “Many other studies of sexual minority youths and their health-risk behaviors have been based on small, convenience samples and case studies that produced nongeneralizable data (3,6,7,17,18).”

[4] Paper: “Covid-19-Related Outcomes in Immunocompromised Patients: A Nationwide Study in Korea.” By Moon Seong Baek and others. PLoS One, October 1, 2021. <journals.plos.org>

The 6,435 Covid-19 patients (≥18 years) included 871 immunocompromised (13.5%) and 5,564 non-immunocompromised (86.5%). Immunocompromised Covid-19 patients were older (60.1±16.4 years vs. 47.1±18.7 years, absolute standardized mean difference: 0.738). The immunocompromised group had more comorbidities, a higher Charlson comorbidity index, and a higher in-hospital mortality rate (9.6% vs. 2.3%; p < .001). The immunocompromised group still had a significantly higher in-hospital mortality rate after inverse probability of treatment weighting (6.4% vs. 2.0%, p < .001). Multivariable analysis adjusted for baseline imbalances revealed that immunocompromised status was independently associated with a higher risk of mortality among COVID-19 patients (adjusted odds ratio [aOR]: 2.09, 95% CI: 1.62–2.68, p < .001). …

Immunocompromised Korean patients with Covid-19 had higher risks of severe illness and mortality, relative to non-immunocompromised patients with COVID-19. In particular, poor outcomes were associated with previous corticosteroid use. Therefore, caution is likely warranted when managing patients with Covid-19 who have a history that includes immunosuppressive conditions and/or treatments.

[5] Clinical Trial 4591001: “Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals.” Information provided by Pfizer BioNTech SE. (Responsible Party). ClinicalTrials.gov. Last updated February 28, 2023. <clinicaltrials.gov>

Exclusion Criteria: …

• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. …

• Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

NOTE: This was the primary study that the FDA used to approve the Pfizer Covid-19 vaccine. Observe that the title of the study states that it was conducted with “Healthy Individuals.”

[6] Clinical Trial mRNA-1273-P301: “A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19.” Information provided by Moderna TX, Inc. (Responsible Party). ClinicalTrials.gov. Last updated January, 12, 2023. <clinicaltrials.gov>

Exclusion Criteria: …

• Immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection, asplenia, and recurrent severe infections.

• Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent).

NOTE: This was the primary study that the FDA used to approve the Moderna Covid-19 vaccine.

[7] Clinical Trial 4591001: “Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals.” Information provided by Pfizer BioNTech SE. (Responsible Party). ClinicalTrials.gov. Last updated February 28, 2023. <clinicaltrials.gov>

“Exclusion Criteria … Previous clinical or microbiological diagnosis of COVID 19.”

NOTE: This was the primary study that the FDA used to approve the Pfizer Covid-19 vaccine.

[8] Clinical Trial mRNA-1273-P301: “A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19.” Information provided by Moderna TX, Inc. (Responsible Party). ClinicalTrials.gov. Last updated January, 12, 2023. <clinicaltrials.gov>

“Exclusion Criteria: … Known history of SARS-CoV-2 infection.”

NOTE: This was the primary study that the FDA used to approve the Moderna Covid-19 vaccine.

[9] Article: “FDA Violated Own Safety and Efficacy Standards in Approving Covid-19 Vaccines For Children.” By James D. Agresti. Just Facts, July 14, 2022. <www.justfactsdaily.com>

Another fatal flaw of the Covid vaccine clinical trials is that less than 15% of the children in these studies showed evidence of prior Covid infection. This makes the trials largely pointless for the bulk of children because:

• roughly 75% of U.S. children aged 0–17 years showed evidence of prior Covid infection in February 2022.
• prior Covid infection causes potent and durable naturally acquired immunity in the vast majority of people.
• adverse reactions to the vaccines may be more common among people who have had prior Covid infections.

The consequences of the facts above are that the trials overstate the benefits of the vaccines and may understate their risks.

The Pfizer and Moderna Covid vaccine trials on adults and older teens explicitly excluded people with a “previous clinical or microbiological diagnosis of Covid 19” or a “known history of SARS-CoV-2 infection.” While the trials on younger children didn’t do this, they included far fewer people with evidence of prior Covid infection than the 75% national rate in early 2022. In the vaccines trials for:

• Pfizer ages 6–23 months, the rate of subjects with evidence of prior Covid infection was 8%.
• Pfizer ages 2–4 years, it was 13%.
• Pfizer ages 5–11 years, it was 9%.
• Pfizer ages 12–15 years, it was 4%.
• Moderna ages 6–23 months, it was 6%.
• Moderna ages 2–5 year, it was 9%.
• Moderna ages 6–11 years, it was 9%.
• Moderna ages 12–17 years, it was 6%.

Given that portion of children who have had Covid-19 is growing and now above the 75% figure in January, the results of those trials are inapplicable to most children.

Compounding the issue, the vaccine manufacturers deliberately excluded children with “evidence of prior” Covid infection from important analyses which the FDA and media are touting to the public. This includes but is not limited to:

• “key analysis sets” for Moderna vaccine efficacy in children aged 6 months to 17 years.
• the “primary” analysis for Pfizer vaccine “effectiveness” in children aged 6 months to 4 years.

Why would the vaccine manufacturers and FDA exclude people who previously had Covid from key analyses and trials? They don’t say, but the following facts prove that including more subjects with naturally acquired immunity would greatly reduce or even negate the claimed efficacy of the vaccines. This is because very few in the placebo group would get Covid-19, and none of them would get severe Covid-19:

• In the Moderna trials for children aged:
  • 6–23 months, only 1 of 88 cases of Covid-19 occurred in children with evidence of prior Covid infection.
  • 2–5 years, only 7 of 190 cases of Covid-19 occurred in children with evidence of prior Covid infection, and 6 of these 7 were in the vaccine group.
  • 12–17 years, “there were no cases of Covid-19” in anyone who showed evidence of prior Covid infection.

• In the Pfizer trials for children aged:
  • 6 months to 4 years, “all Covid-19 cases in these analyses occurred in participants without evidence of prior SARS-CoV-2 infection,” even while “the Omicron variant was prevalent in the United States.”
  • 5–11 years, “all cases of Covid-19” occurred in children “without prior history of SARS-CoV-2 infection.”
  • 12– 15 years, 2 cases of Covid-19 occurred in children who showed evidence of prior Covid infection.

• In the Moderna and Pfizer trials, no severe cases of Covid-19 occurred in children of any age who showed evidence of prior Covid infection.

• A study published in 2022 by The Lancet examined reported Covid infections among children aged 16 years and younger in England, where the government keeps meticulous healthcare records on nearly all citizens. The study found that:
  • 0.7% of the 688,418 children who had Covid from the outset of the pandemic in early 2020 through July 31, 2021 were reinfected over that period.
  • 0.02% of the nation’s children were reinfected.
  • no child died from a Covid reinfection.

The facts above show that excluding children with naturally acquired immunity exaggerates vaccine efficacy. The facts below show how excluding them may also understate the risks of the vaccines:

• In the Moderna trials for children aged:
  • 6–23 months and 2–5 years, children with evidence of prior Covid infection had substantially higher rates of fevers when given the vaccines.
  • 6–11 years, children with evidence of prior Covid infection had substantially higher rates (10+ percentage points) of “systemic adverse reactions” to the first dose of the vaccine, including fevers, headaches, myalgia (muscle pain), and chills.
  • 12–17 years, children with evidence of prior Covid infection had substantially higher rates of “systemic adverse reactions” to the first dose of the vaccine, including fevers, headaches, fatigue, myalgia, arthralgia (joint pain), and chills.

• a February 2021 paper in the World Allergy Organization Journal reports that “the vast majority of adverse events following immunization are a consequence of the vaccine stimulating a protective immune response” instead of allergic reactions. Since people with naturally acquired immunity mount strong immune responses to a wide array of SARS-CoV-2 variants, this may make them prone to such vaccine-induced adverse events.

Children who had Covid had about the same rate of problems on the second dose as those who did not have Covid. This is because children with naturally acquired immunity had roughly the same rates of adverse reactions on each dose, while those without evidence of prior Covid infection had substantially higher rates of adverse reactions on the second dose than the first. This adds to the evidence that adverse reactions to the vaccines can be caused by immune responses to it.

Because the trials included few children with evidence of prior Covid infection, the available data should be taken with a grain of salt. However, it signals a potential hazard that deserves more investigation than the vaccine manufacturers and FDA have conducted and published.

[10] Press release: “Coronavirus (Covid-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Covid-19 Vaccines for Children Down to 6 Months of Age.” U.S. Food and Drug Administration, June 17, 2022. <bit.ly>

Key points:

• The FDA’s evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs [emergency use authorizations].

• The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine. …

“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

NOTE: This FDA press release says nothing about the narrow nature of the studies that underlie this decision except that some of them involved children “without evidence of prior infection.” See the second footnote below for the vital implications of this.

[11] Press release: “CDC Recommends Covid-19 Vaccines for Young Children.” U.S. Centers for Disease Control and Prevention, June 18, 2022. <www.cdc.gov>

Today, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that all children 6 months through 5 years of age should receive a Covid-19 vaccine. …

… All children, including children who have already had Covid-19, should get vaccinated.

COVID-19 vaccines have undergone—and will continue to undergo—the most intensive safety monitoring in U.S. history. …

The following is attributable to CDC Director Dr. Rochelle P. Walensky:

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against Covid-19. We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can. I encourage parents and caregivers with questions to talk to their doctor, nurse, or local pharmacist to learn more about the benefits of vaccinations and the importance of protecting their children by getting them vaccinated.”

NOTE: This CDC press release says nothing about the narrow nature of the studies that underlie this decision. See the next footnote for the vital implications of this.

[12] Article: “FDA Violated Own Safety and Efficacy Standards in Approving Covid-19 Vaccines For Children.” By James D. Agresti. Just Facts, July 14, 2022. <www.justfactsdaily.com>

“Related” Adverse Events

The grave risks of using underpowered studies are heightened for Covid vaccines in children because severe reactions have occurred even in the small studies conducted thus far. This may be a sign of much worse effects if the studies were properly powered.

The following examples of “severe” or “serious” adverse reactions are reported in FDA documents about the child clinical trials for the Moderna and Pfizer Covid-19 vaccines. In these cases and others, the FDA and drug manufacturers agreed that the reactions are “related” or “possibly related” to the vaccines:

• In a study of 2,400 children aged 6–23 months, a 17-month-old girl developed a fever of 103.1 ºF one day after the first dose of the Moderna vaccine, followed by a “convulsion” on the next day.
• In a study of 1,776 children aged 6–23 months, a 6-month-old developed eye-rolling seizures two days after the second dose of the Pfizer vaccine, leading to hospitalization. All symptoms resolved “17 days after onset,” and “the participant was withdrawn from the study by parental request.”
• In a study of 2,750 children aged 2–4 years, a 4-year-old child developed calf pain and a fever of 104.5 ºF two days after the second dose of the Pfizer vaccine, leading to hospitalization, a limp, and a rash on his/her face, chest, and upper back. All symptoms resolved by the 10th day.

Notably, both the Moderna and Pfizer studies excluded children apt to have serious side effects from vaccines, like those with “history of severe adverse reaction associated with a vaccine” and “individuals with a history of autoimmune disease or an active autoimmune disease.” Ignoring this fact, the CDC relied on these studies to recommend that “all children” aged 6 months through 5 years receive a Covid-19 vaccine. …

Naturally Immune Omitted

Another fatal flaw of the Covid vaccine clinical trials is that less than 15% of the children in these studies showed evidence of prior Covid infection. This makes the trials largely pointless for the bulk of children because:

• roughly 75% of U.S. children aged 0–17 years showed evidence of prior Covid infection in February 2022.
• prior Covid infection causes potent and durable naturally acquired immunity in the vast majority of people.
• adverse reactions to the vaccines may be more common among people who have had prior Covid infections.

The consequences of the facts above are that the trials overstate the benefits of the vaccines and may understate their risks.

The Pfizer and Moderna Covid vaccine trials on adults and older teens explicitly excluded people with a “previous clinical or microbiological diagnosis of Covid 19” or a “known history of SARS-CoV-2 infection.” While the trials on younger children didn’t do this, they included far fewer people with evidence of prior Covid infection than the 75% national rate in early 2022. In the vaccines trials for:

• Pfizer ages 6–23 months, the rate of subjects with evidence of prior Covid infection was 8%.
• Pfizer ages 2–4 years, it was 13%.
• Pfizer ages 5–11 years, it was 9%.
• Pfizer ages 12–15 years, it was 4%.
• Moderna ages 6–23 months, it was 6%.
• Moderna ages 2–5 year, it was 9%.
• Moderna ages 6–11 years, it was 9%.
• Moderna ages 12–17 years, it was 6%.

Given that portion of children who have had Covid-19 is growing and now above the 75% figure in January, the results of those trials are inapplicable to most children.

Compounding the issue, the vaccine manufacturers deliberately excluded children with “evidence of prior” Covid infection from important analyses which the FDA and media are touting to the public. This includes but is not limited to:

• “key analysis sets” for Moderna vaccine efficacy in children aged 6 months to 17 years.
• the “primary” analysis for Pfizer vaccine “effectiveness” in children aged 6 months to 4 years.

Why would the vaccine manufacturers and FDA exclude people who previously had Covid from key analyses and trials? They don’t say, but the following facts prove that including more subjects with naturally acquired immunity would greatly reduce or even negate the claimed efficacy of the vaccines. This is because very few in the placebo group would get Covid-19, and none of them would get severe Covid-19:

• In the Moderna trials for children aged:
  • 6–23 months, only 1 of 88 cases of Covid-19 occurred in children with evidence of prior Covid infection.
  • 2–5 years, only 7 of 190 cases of Covid-19 occurred in children with evidence of prior Covid infection, and 6 of these 7 were in the vaccine group.
  • 12–17 years, “there were no cases of Covid-19” in anyone who showed evidence of prior Covid infection.

• In the Pfizer trials for children aged:
  • 6 months to 4 years, “all Covid-19 cases in these analyses occurred in participants without evidence of prior SARS-CoV-2 infection,” even while “the Omicron variant was prevalent in the United States.”
  • 5–11 years, “all cases of Covid-19” occurred in children “without prior history of SARS-CoV-2 infection.”
  • 12– 15 years, 2 cases of Covid-19 occurred in children who showed evidence of prior Covid infection.

• In the Moderna and Pfizer trials, no severe cases of Covid-19 occurred in children of any age who showed evidence of prior Covid infection.

• A study published in 2022 by The Lancet examined reported Covid infections among children aged 16 years and younger in England, where the government keeps meticulous healthcare records on nearly all citizens. The study found that:
  • 0.7% of the 688,418 children who had Covid from the outset of the pandemic in early 2020 through July 31, 2021 were reinfected over that period.
  • 0.02% of the nation’s children were reinfected.
  • no child died from a Covid reinfection.

The facts above show that excluding children with naturally acquired immunity exaggerates vaccine efficacy. The facts below show how excluding them may also understate the risks of the vaccines:

• In the Moderna trials for children aged:
  • 6–23 months and 2–5 years, children with evidence of prior Covid infection had substantially higher rates of fevers when given the vaccines.
  • 6–11 years, children with evidence of prior Covid infection had substantially higher rates (10+ percentage points) of “systemic adverse reactions” to the first dose of the vaccine, including fevers, headaches, myalgia (muscle pain), and chills.
  • 12–17 years, children with evidence of prior Covid infection had substantially higher rates of “systemic adverse reactions” to the first dose of the vaccine, including fevers, headaches, fatigue, myalgia, arthralgia (joint pain), and chills.

• a February 2021 paper in the World Allergy Organization Journal reports that “the vast majority of adverse events following immunization are a consequence of the vaccine stimulating a protective immune response” instead of allergic reactions. Since people with naturally acquired immunity mount strong immune responses to a wide array of SARS-CoV-2 variants, this may make them prone to such vaccine-induced adverse events.

Children who had Covid had about the same rate of problems on the second dose as those who did not have Covid. This is because children with naturally acquired immunity had roughly the same rates of adverse reactions on each dose, while those without evidence of prior Covid infection had substantially higher rates of adverse reactions on the second dose than the first. This adds to the evidence that adverse reactions to the vaccines can be caused by immune responses to it.

Because the trials included few children with evidence of prior Covid infection, the available data should be taken with a grain of salt. However, it signals a potential hazard that deserves more investigation than the vaccine manufacturers and FDA have conducted and published.

[13] Article: “Everything You Always Wanted to Know About Masks, and the Deadly Falsehoods Surrounding Them.” By James D. Agresti, Just Facts, September 13, 2021. <www.justfacts.com>

In July 2020, the Journal of the American Medical Association published a commentary titled “Universal Masking to Prevent SARS-CoV-2 Transmission—The Time Is Now.” The authors—all of whom were CDC employees—argued that the benefits of using masks during surgery are relevant to the general public. This leap of logic conflates surgical masks with cloth masks, sterilized operating rooms with subways, and open wounds with people’s faces.

The authors also claimed—without citing any research—that it would be “absurd” to conduct surgery without masks “because it is known that use of face coverings under these circumstances reduces the risk of surgical site infection caused by microbes generated during the surgical team’s conversations or breathing.”

That assertion is at direct odds with the strongest, most relevant research on this issue. This was summarized in a 2016 paper published by “the leading journal and database for systematic reviews in health care.” After conducting an extensive search for all available RCTs on the use of surgical masks to prevent wound infections, the authors located three trials and found “there was no statistically significant difference in infection rates between the masked and unmasked group in any of the trials.”

This straightforward example dramatically illustrates how the claims of “experts” published in one of the world’s leading medical journals can be at odds with documented facts. Yet with callous disregard for the facts—and thus the wellbeing of people—Google/YouTube, Facebook, and Twitter have banned factual statements about masks that conflict with the opinion of their chosen experts. …

While ignoring this wealth of strong, comprehensive studies, the CDC’s Covid-19 guidance for K-12 schools declares:

• “Masks should be worn indoors by all individuals (age 2 and older) who are not fully vaccinated.”
• Even if vaccinated, all “passengers and drivers must wear a mask on school buses” with few exceptions.
• “Based on the needs of the community, school administrators may opt to make mask use universally required (i.e., required regardless of vaccination status) in the school.”

The CDC claims that those policies are “based on current scientific evidence” while linking to a CDC “Science Brief” which cites observational studies that prove nothing of the sort. For example, the brief cites:

• a contact-tracing study of 90,000 students and staff in a sample of North Carolina schools:
  • that operated with less than half of their students present each day and had mask and social distancing requirements.
  • where the researchers could not “determine the relative effectiveness of any specific school policies.”
  • in which C-19 “testing could not be universally enforced” because students were “not required to return to school” at any time.
  • where the researchers “were not able to analyze incidence of child-to-child or adult-to-child transmission” due to “confidentiality concerns.”

• a study which concludes that reopening schools was probably not “a driver of the second Covid-19 wave in Italy” and:
  • found that the C-19 infection rate “among students was lower than in the general population.”
  • reports that both students and adults were subject to a “mandate for universal mask wearing outside home.”
  • found that “school age children and adolescents” are “largely spared from the clinical consequences” of C-19, “are less likely to transmit it,” and often “harbor antibodies” that may protect them from it.
  • states that “decision makers, popular press and public opinion in Italy” wrongly “ascribed the second wave of COVID-19 to school reopening” and made “deprecating comments” about teens “who would not follow the strict rules at school or outside them.”

After proclaiming that those and other studies demonstrate the “success” of mask mandates, the CDC cites two observational studies that supposedly show “inconsistent mask use may have contributed to school-based outbreaks.” Absurdly, these consist of:

• a study of a C-19 outbreak in a single Israeli school during a heat wave when:
  • the nation’s “Ministry of Health exempted schoolchildren from facemasks” for three days.
  • the students and teachers were confined to “crowded” classrooms containing 35 to 38 students.
  • windows and doors were closed while “air-conditioning functioned continuously in all classes.”
  • “distancing among students and between students and teachers was not possible.”

• a study of C-19 infections “in a single school district” in Georgia where:
  • “nine clusters” of Covid-19 cases occurred among “13 educators and 32 students at six elementary schools.”
  • “the school district mandated in-classroom mask use except while eating, and both reported and observed compliance during site visits was high.”
  • “interviews with parents, educators, and principals” indicated a “lack of or inadequate mask use by students” in five of the nine clusters.

In other words, the CDC blames a handful of C-19 cases on less-than-perfect mask usage in a school district where masks were required, compliance was “high,” and interviews failed to detect even slight non-compliance in four of the nine clusters that caught C-19. Yet, the CDC ignores two million students in Sweden who rarely wore masks, rarely became infected, and not one of whom died from C-19.

After closing out the section on masks, the same CDC “Science Brief” craftily slips the following statement into a section on “Physical Distancing”:

K–5 schools in Norway had minimal child-to-child and child-to-adult transmission with masks only required for adults, one meter between all individuals, and two meters between student cohorts.

In reality, the study mentions masks only once and states: “Use of face masks is not recommended in schools in Norway.” This means that C-19 transmission was minimal in schools that practiced social distancing but did not require or even recommend masks. Put bluntly, the CDC buried and twisted this fact that undermines their central claim.

The CDC makes it very difficult for readers to notice how they distort these studies. They do this by using unclickable footnotes and failing to link to the vast majority of the sources they cite. Thus, readers must note the footnote numbers, scroll down to the bottom of the webpage to locate the source, conduct a separate search for the source, and then scroll back up to the location where they were reading. Compare that runaround to a typical academic journal, where all of this can be done with a few simple clicks.

[14] Articles: “Coronavirus Updates: C.D.C. Recommends 2 Covid Vaccines for Very Young Children.” New York Times, June 18, 2022. <www.nytimes.com>

Scientific advisers to the Centers for Disease Control and Prevention unanimously decided the benefits outweigh the risks for children under 5 despite some reservations about thin data on efficacy, and the agency’s director signed off on the shots. …

All children 6 months and older, including those who have already been infected with the coronavirus, should get a Covid vaccine, Dr. Rochelle P. Walensky, the C.D.C.’s director, said in a statement.

“Together, with science leading the charge, we have taken  another important step  forward  in our nation’s fight against Covid-19,” she said. “We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can.”

NOTE: This series of eight New York Times articles about the CDC’s recommendation to inject “all children 6 months and older” with Covid-19 vaccines reveals nothing about the narrow nature of the studies that underlie this decision. See the second footnote below for the vital implications of this.

[15] Article: “Coronavirus Vaccines for Kids Under 5 Are Finally Here.” By Lena H. Sun and Joel Achenbach. Washington Post, June 18, 2022. <www.washingtonpost.com>

Pediatricians are preparing to administer the nation’s first coronavirus vaccines for children under 5 in coming days, after the Centers for Disease Control and Prevention on Saturday signed off on giving the shots to as many as 19 million children across the United States.

CDC Director Rochelle Walensky endorsed the agency’s advisory panel’s unanimous recommendation to vaccinate all children as young as 6 months old with one of two vaccines — one by Moderna and the other by Pfizer and its German partner, BioNTech. …

The conclusion of this long, deliberate regulatory process, with the final signature from Walensky coming at the start of the busy summer travel season, will be a welcome relief for families who have seen the lack of vaccination among children as a major obstacle to intergenerational gatherings. …

“This is an opportunity which one doesn’t get very often to participate in preventing the death of children, of young children,” said panel member Beth Bell, a global health professor at the University of Washington, following a two-day meeting that concluded Saturday. …

Roughly three out of four children carry antibodies showing that they have already been infected at least once with the coronavirus, according to research published earlier this year. The CDC emphasized that children who have had the virus should still be vaccinated to protect against reinfection — as well as to protect their family members and communities. …

The clinical trials involved thousands of children during the omicron variant wave this past winter. Side effects from vaccinations were minimal — pain at the injection site being the most common — and were comparable to what is seen in other pediatric vaccines.

NOTE: This Washington Post article about the CDC’s “recommendation to vaccinate all children as young as 6 months old with one of two” Covid-19 vaccines reveals nothing about the narrow nature of the studies that underlie this decision except that “there was not enough data to make a definitive estimate of the benefit against severe disease” “among the youngest children in the clinical trials.” See the footnote below for the vital implications of this.

[16] Article: “FDA Violated Own Safety and Efficacy Standards in Approving Covid-19 Vaccines For Children.” By James D. Agresti. Just Facts, July 14, 2022. <www.justfactsdaily.com>

“Related” Adverse Events

The grave risks of using underpowered studies are heightened for Covid vaccines in children because severe reactions have occurred even in the small studies conducted thus far. This may be a sign of much worse effects if the studies were properly powered.

The following examples of “severe” or “serious” adverse reactions are reported in FDA documents about the child clinical trials for the Moderna and Pfizer Covid-19 vaccines. In these cases and others, the FDA and drug manufacturers agreed that the reactions are “related” or “possibly related” to the vaccines:

• In a study of 2,400 children aged 6–23 months, a 17-month-old girl developed a fever of 103.1 ºF one day after the first dose of the Moderna vaccine, followed by a “convulsion” on the next day.
• In a study of 1,776 children aged 6–23 months, a 6-month-old developed eye-rolling seizures two days after the second dose of the Pfizer vaccine, leading to hospitalization. All symptoms resolved “17 days after onset,” and “the participant was withdrawn from the study by parental request.”
• In a study of 2,750 children aged 2–4 years, a 4-year-old child developed calf pain and a fever of 104.5 ºF two days after the second dose of the Pfizer vaccine, leading to hospitalization, a limp, and a rash on his/her face, chest, and upper back. All symptoms resolved by the 10th day.

Notably, both the Moderna and Pfizer studies excluded children apt to have serious side effects from vaccines, like those with “history of severe adverse reaction associated with a vaccine” and “individuals with a history of autoimmune disease or an active autoimmune disease.” Ignoring this fact, the CDC relied on these studies to recommend that “all children” aged 6 months through 5 years receive a Covid-19 vaccine. …

Naturally Immune Omitted

Another fatal flaw of the Covid vaccine clinical trials is that less than 15% of the children in these studies showed evidence of prior Covid infection. This makes the trials largely pointless for the bulk of children because:

• roughly 75% of U.S. children aged 0–17 years showed evidence of prior Covid infection in February 2022.
• prior Covid infection causes potent and durable naturally acquired immunity in the vast majority of people.
• adverse reactions to the vaccines may be more common among people who have had prior Covid infections.

The consequences of the facts above are that the trials overstate the benefits of the vaccines and may understate their risks.

The Pfizer and Moderna Covid vaccine trials on adults and older teens explicitly excluded people with a “previous clinical or microbiological diagnosis of Covid 19” or a “known history of SARS-CoV-2 infection.” While the trials on younger children didn’t do this, they included far fewer people with evidence of prior Covid infection than the 75% national rate in early 2022. In the vaccines trials for:

• Pfizer ages 6–23 months, the rate of subjects with evidence of prior Covid infection was 8%.
• Pfizer ages 2–4 years, it was 13%.
• Pfizer ages 5–11 years, it was 9%.
• Pfizer ages 12–15 years, it was 4%.
• Moderna ages 6–23 months, it was 6%.
• Moderna ages 2–5 year, it was 9%.
• Moderna ages 6–11 years, it was 9%.
• Moderna ages 12–17 years, it was 6%.

Given that portion of children who have had Covid-19 is growing and now above the 75% figure in January, the results of those trials are inapplicable to most children.

Compounding the issue, the vaccine manufacturers deliberately excluded children with “evidence of prior” Covid infection from important analyses which the FDA and media are touting to the public. This includes but is not limited to:

• “key analysis sets” for Moderna vaccine efficacy in children aged 6 months to 17 years.
• the “primary” analysis for Pfizer vaccine “effectiveness” in children aged 6 months to 4 years.

Why would the vaccine manufacturers and FDA exclude people who previously had Covid from key analyses and trials? They don’t say, but the following facts prove that including more subjects with naturally acquired immunity would greatly reduce or even negate the claimed efficacy of the vaccines. This is because very few in the placebo group would get Covid-19, and none of them would get severe Covid-19:

• In the Moderna trials for children aged:
  • 6–23 months, only 1 of 88 cases of Covid-19 occurred in children with evidence of prior Covid infection.
  • 2–5 years, only 7 of 190 cases of Covid-19 occurred in children with evidence of prior Covid infection, and 6 of these 7 were in the vaccine group.
  • 12–17 years, “there were no cases of Covid-19” in anyone who showed evidence of prior Covid infection.

• In the Pfizer trials for children aged:
  • 6 months to 4 years, “all Covid-19 cases in these analyses occurred in participants without evidence of prior SARS-CoV-2 infection,” even while “the Omicron variant was prevalent in the United States.”
  • 5–11 years, “all cases of Covid-19” occurred in children “without prior history of SARS-CoV-2 infection.”
  • 12– 15 years, 2 cases of Covid-19 occurred in children who showed evidence of prior Covid infection.

• In the Moderna and Pfizer trials, no severe cases of Covid-19 occurred in children of any age who showed evidence of prior Covid infection.

• A study published in 2022 by The Lancet examined reported Covid infections among children aged 16 years and younger in England, where the government keeps meticulous healthcare records on nearly all citizens. The study found that:
  • 0.7% of the 688,418 children who had Covid from the outset of the pandemic in early 2020 through July 31, 2021 were reinfected over that period.
  • 0.02% of the nation’s children were reinfected.
  • no child died from a Covid reinfection.

The facts above show that excluding children with naturally acquired immunity exaggerates vaccine efficacy. The facts below show how excluding them may also understate the risks of the vaccines:

• In the Moderna trials for children aged:
  • 6–23 months and 2–5 years, children with evidence of prior Covid infection had substantially higher rates of fevers when given the vaccines.
  • 6–11 years, children with evidence of prior Covid infection had substantially higher rates (10+ percentage points) of “systemic adverse reactions” to the first dose of the vaccine, including fevers, headaches, myalgia (muscle pain), and chills.
  • 12–17 years, children with evidence of prior Covid infection had substantially higher rates of “systemic adverse reactions” to the first dose of the vaccine, including fevers, headaches, fatigue, myalgia, arthralgia (joint pain), and chills.

• a February 2021 paper in the World Allergy Organization Journal reports that “the vast majority of adverse events following immunization are a consequence of the vaccine stimulating a protective immune response” instead of allergic reactions. Since people with naturally acquired immunity mount strong immune responses to a wide array of SARS-CoV-2 variants, this may make them prone to such vaccine-induced adverse events.

Children who had Covid had about the same rate of problems on the second dose as those who did not have Covid. This is because children with naturally acquired immunity had roughly the same rates of adverse reactions on each dose, while those without evidence of prior Covid infection had substantially higher rates of adverse reactions on the second dose than the first. This adds to the evidence that adverse reactions to the vaccines can be caused by immune responses to it.

Because the trials included few children with evidence of prior Covid infection, the available data should be taken with a grain of salt. However, it signals a potential hazard that deserves more investigation than the vaccine manufacturers and FDA have conducted and published.

[17] Article: “Electric Vehicles Contribute Fewer Emissions Than Gasoline-Powered Cars Over Their Lifetimes.” By Catalina Jaramillo. FactCheck.org, February 7, 2024. <www.factcheck.org>

Q: Are electric cars really better for the environment than gasoline-powered cars over their lifetimes?

A: Yes. Electric vehicles typically release fewer greenhouse gas emissions than internal combustion engine vehicles during their life cycles, even after accounting for the increased energy required to make their batteries. …

“Electric vehicles are better for the environment. Full stop,” Austin Brown, director of the U.S. Department of Energy’s Vehicle Technologies Office, told us in a phone interview. “There are tons of complexity underneath that, but … in every metric that we use to measure environmental impact, that we know how to really quantify, electric vehicles are better for the environment now, and they will continue to improve.”

NOTE: This 2,300-word article repeatedly asserts that electric vehicles are better for the environment than conventional cars, but the author only cites studies that account for greenhouse gases, which ignores the vast array of toxic pollutants emitted by electric vehicles. See the next footnote for the implications of this.

[18] Article: “Electric Cars Are Not ‘Zero-Emission Vehicles.” By James D. Agresti. Just Facts, September 2, 2022. <www.justfactsdaily.com>

Toxic Pollution

The notion that electric vehicles are “zero-emission” is rooted in a deceptive narrative that ignores all pollutants which don’t come out of a tailpipe. Assessing the environmental impacts of energy technologies requires measuring all forms of pollution they emit over their entire lives, not a narrow slice of them. To do this, researchers perform “life cycle assessments” or LCAs. As explained by the Environmental Protection Agency, LCAs allow for:

LCAs are subject to multiple levels of uncertainty, but an assessment published by the Journal of Cleaner Production in 2021 shatters the notion that electric cars are cleaner than conventional ones, much less “zero emission.” The LCA found that manufacturing, charging, operating, and disposing of electric vehicles produces more of every major category of pollutants than conventional cars. This includes:
 

Foreshadowing that result, a 2018 report by the European Environment Agency warned that studies on the “human toxicity impacts” of electric vehicles were “limited” and that electric cars “could be responsible for greater negative impacts” than conventional cars.

Similarly, a 2018 article in the journal Environmental Research Letters stated that a failure to account for the “environmental implications” of mining lithium to make batteries for electric cars “would directly counter the intent” of “incentivizing electric vehicle adoption” and “needs to be urgently addressed.”

The 2021 paper in the Journal of Cleaner Production has now addressed this issue, and it shows electric cars emit more toxic pollution than gasoline-powered cars. Yet, politicians who embraced the electric car agenda before comprehensive data was available continue to plow ahead in spite of the facts.

Local Pollution

Regardless of overall toxic emissions, the European Environment Agency points out that electric vehicles “potentially offer local air quality benefits” because pollution from their manufacturing, charging, and disposal is usually emitted away from densely populated areas.

Simply stated, switching to electric cars transfers pollution from urbanites in wealthy nations to poor countries that mine and manufacture their components and to communities with power plants and disposal sites. In the words of the 2021 paper in the Journal of Cleaner Production, this “transfer of environmental burdens” causes “workers and ecosystems in third countries” to be “exposed to higher rates of toxic substances.”

China dominates the global supply chains for green energy components not merely because of cheap labor but because they have lax environmental standards that tolerate the pollution these products create. Thus, China supplies 78% of the world’s solar cells, 80% of the world’s lithium-ion battery chemicals, and 73% of the world’s finished battery cells.

Highlighting the implications of “China’s role in supplying critical minerals for the global energy transition,” a 2022 study by the Brookings Institute found that “continued reliance on China” will “increase the risk that sourcing of critical minerals will cause or contribute to serious social or environmental harms.” It also documents that the U.S. and other wealthy nations have been unwilling to accept these harms on their own soils.

Even if Newsom disregards the health of poor and slave laborers in other nations, electric vehicles are still not “zero-emission” for the people of California. This is because electric vehicles emit pollutants from road, tire, and brake wear, and these forms of pollution are worse in electric vehicles than standard cars. Per a 2016 paper in the journal Atmospheric Environment, “Electric vehicles are 24% heavier than their conventional counterparts,” and this creates more “non-exhaust emissions” like “tire wear, brake wear, road surface wear and resuspension of road dust.”

[19] Article: “Experts Say There’s No Evidence That Masks Harm Kids’ Health Despite Baseless Claims.” By Lindsey Tanner. Associated Press, September 16, 2021. <www.latimes.com>

There’s strong evidence masking children in schools can reduce Covid-19 transmission to other children and adults.

Across 166 schools in Maricopa County, Arizona, COVID-19 outbreaks are two times more common at those without mask mandates, said Dr. Rebecca Sunenshine, medical director of the county’s public health department.

Studies from school districts in other states including North Carolina have also found that masking can greatly reduce COVID-19 transmission rates, especially when it’s combined with physical distancing and other prevention measures.

NOTES:

• This Associated Press “fact check” reveals nothing about the narrow nature of the two studies that it calls “strong evidence.” See the next two footnotes for the vital implications of this.
• Incidentally, this “fact check” also claims “there is no scientific evidence showing masks cause harm to kids’ health,” a statement disproven by a wealth of facts.

[20] Paper: “Lack of Correlation Between School Mask Mandates and Paediatric Covid-19 Cases in a Large Cohort.” By Ambarish Chandra and Tracy Beth Høeg. Journal of Infection, September 29, 2022. <www.journalofinfection.com>

Objectives

To expand upon an observational study published by the Centers for Disease Control (CDC) showing an association between school mask mandates and lower pediatric Covid-19 cases. We examine whether this association persists in a larger, nationally representative dataset over a longer period.

Method

We replicated the CDC study and extended it to more districts and a longer period, employing seven times as much data. We examined the relationship between mask mandates and per-capita pediatric cases, using multiple regression to control for observed differences.

Results

We successfully replicated the original result using 565 counties; non-masking counties had around 30 additional daily cases per 100,000 children after two weeks of schools reopening. However, after nine weeks, cases per 100,000 were 18.3 in counties with mandates compared to 15.8 in those without them (p = 0.12). In a larger sample of 1,832 counties, between weeks 2 and 9, cases per 100,000 fell by 38.2 and 37.9 in counties with and without mask requirements, respectively (p = 0.93).

Conclusions

The association between school mask mandates and cases did not persist in the extended sample. Observational studies of interventions are prone to multiple biases and provide insufficient evidence for recommending mask mandates.

[21] Article: “Everything You Always Wanted to Know About Masks, and the Deadly Falsehoods Surrounding Them.” By James D. Agresti, Just Facts, September 13, 2021. <www.justfacts.com>

The CDC claims that those policies are “based on current scientific evidence” while linking to a CDC “Science Brief” which cites observational studies that prove nothing of the sort. For example, the brief cites:

• a contact-tracing study of 90,000 students and staff in a sample of North Carolina schools:
  • that operated with less than half of their students present each day and had mask and social distancing requirements.
  • where the researchers could not “determine the relative effectiveness of any specific school policies.”
  • in which C-19 “testing could not be universally enforced” because students were “not required to return to school” at any time.
  • where the researchers “were not able to analyze incidence of child-to-child or adult-to-child transmission” due to “confidentiality concerns.”

[22] Paper: “A Reanalysis of the High/Scope Perry Preschool Program.” By James Heckman and others. University of Chicago, January 22, 2010. <www.researchgate.net>

Page 2: “The case for universal pre-K is often based on the Perry study, even though the project only targeted a disadvantaged segment of the population.¹”

[23] Commentary: “The Vague Promise of Obama’s Ambitious Preschool Plan.” By Jonathan Cohn. New Republic, February 15, 2013. <www.newrepublic.com>

“President Barack Obama visited Georgia on Thursday to tout his ambitious new proposal for universal preschool. … Obama’s plan comes from two ‘amazing preschools’—the Perry Preschool Project, in Michigan, and the Abecedarian Project, in North Carolina.”

[24] Report: “The Case for Pre-K in Education Reform: A Summary of Program Evaluation Findings.” By Albert Wat. Pew Center on the States, April 2010. <www.pewtrusts.org>

Page 2:

The short- and long-term benefits of high-quality pre-kindergarten have been well documented by researchers for the last 50 years. By now, even many outside the education field have heard about the academic and lifetime gains and the significant returns on investment yielded from the High/Scope Perry Preschool Project and the Chicago Child-Parent Centers.¹

¹ See for example: Albert Wat, “Dollars and Sense: A Review of Economic Analyses of Pre-K,” (Washington, DC: Pre-K Now, 2007).

[25] Paper: “Multiple Inference and Gender Differences in the Effects of Early Intervention: A Reevaluation of the Abecedarian, Perry Preschool, and Early Training Projects.” By Michael L. Anderson. Journal of the American Statistical Association, December 2008. Pages 1481–1495. <are.berkeley.edu>

Page 1481:

The education literature contains dozens of papers showing inconsistent or low returns to publicly funded human capital investments…. In contrast to these studies, several randomized early intervention experiments have reported striking increases in short-term IQ scores and long-term outcomes for treated children… These results have been highly influential and often are cited as proof of efficacy for many types of early interventions…. The experiments underlie the growing movement for universal prekindergarten education….

This article focuses on the three prominent early intervention experiments: the Abecedarian Project, the Perry Preschool Program, and the Early Training Project.

Page 1493: “[T]he Perry Preschool Project [is] arguably the most influential of the three experiments.”

[26] Paper: “The Rate of Return to the High/Scope Perry Preschool Program.” By James J. Heckman and others. U.S. National Library of Medicine, National Institutes of Health, February 2010. <www.ncbi.nlm.nih.gov>

Page 5: “As the oldest and most cited early childhood intervention evaluated by the method of random assignment, the Perry study serves as a flagship for policy makers advocating public support for early childhood programs.”

[27] Paper: “Multiple Inference and Gender Differences in the Effects of Early Intervention: A Reevaluation of the Abecedarian, Perry Preschool, and Early Training Projects.” By Michael L. Anderson. Journal of the American Statistical Association, December 2008. Pages 1481–1495. <are.berkeley.edu>

[28] Paper: “A Reanalysis of the High/Scope Perry Preschool Program.” By James Heckman and others. University of Chicago, January 22, 2010. <www.researchgate.net>

Page 2:

The High/Scope Perry Preschool program, conducted in the 1960s, was an early childhood intervention that provided preschool to low-IQ, disadvantaged African-American children living in Ypsilanti, Michigan, a town near Detroit. … The beneficial long-term effects reported for the Perry program constitute a cornerstone of the argument for early intervention efforts throughout the world.

Page 2: “The study was evaluated by the method of random assignment.”

[29] Book: Rutherford’s Vascular Surgery (8th edition, Volume 1). Edited by Jack L. Cronenwet and K. Wayne Johnston. Elsevier Saunders, 2014.

Chapter 1: “Epidemiology and Clinical Analysis.” By Loius L. Nguyen and Ann DeBord Smith.” Pages 2–14.

The goal of this chapter is to introduce the vascular surgeon to the principles that underlie the design, conduct, and interpretation of clinical research. … This chapter serves as a foundation for clinicians to better interpret clinical results and as a guide for researchers to further expand clinical analysis. …

Experimental studies differ from observational studies in that the former expose patients to a treatment being tested. Many experimental trials involve randomization of patients to the treatment group or appropriate control group. Although randomization ensures that known factors are evenly distributed between the exposure and control groups, the importance of RCTs [randomized controlled trials] lies in the even distribution of unknown factors. Thus, a well-designed RCT will result in more simplified endpoint analyses because complex statistical models are nor necessary to control for confounding factors. …

Double-blinded trials are conducted so that both clinicians and patients are unaware of the treatment assignment. Often, a separate research group is responsible for the randomization allocation and has minimal or no contact with the clinicians and patients. …

Although RCTs represent the pinnacle in clinical design, there are many situations in which RCTs are impractical or impossible. Clinical equipoise may not exist, or common sense may prevent randomization of well-established practices, such as the use of parachutes.⁶ RCTs are also costly to conduct and must generate a new control group with each trial.

[30] Paper: “Randomised Controlled Trials – The Gold Standard for Effectiveness Research.” By Eduardo Hariton & Joseph J. Locascio. BJOG (British Journal of Obstetrics & Gynecology), June 19, 2018. <obgyn.onlinelibrary.wiley.com>

Randomised controlled trials (RCTs) are the reference standard for studying causal relationships between interventions and outcomes as randomisation eliminates much of the bias inherent with other study designs. …

RCTs are prospective studies that measure the effectiveness of interventions. Although no study is likely on its own to prove causality, randomisation reduces bias and provides a rigorous tool to examine cause–effect relationships between an intervention and outcome. This is because the act of randomisation in a large study balances participant characteristics (both observed and unobserved) between the groups, allowing attribution of any differences in outcome to the intervention. This is not possible with any other study design, so RCTs are considered the reference standard for driving practice….

[31] Paper: “Randomized Controlled Trials.” Deutsches Ärzteblatt International (The German Medical Association’s Official International Bilingual Science Journal). By Maria Kabisch and others. September 30, 2011. <www.ncbi.nlm.nih.gov>

In clinical research, randomized controlled trials (RCTs) are the best way to study the safety and efficacy of new treatments. RCTs are used to answer patient-related questions and are required by governmental regulatory bodies as the basis for approval decisions. …

In RCTs the patients are randomly assigned to the different study groups. This is intended to ensure that all potential confounding factors are divided equally among the groups that will later be compared (structural equivalence). These factors are characteristics that may affect the patients’ response to treatment, e.g., weight, age, and sex. Only if the groups are structurally equivalent can any differences in the results be attributed to a treatment effect rather than the influence of confounders. …

In a double-blind study neither patient nor study physician knows to which treatment the patient has been assigned. Double-blind studies are advantageous if knowledge of the treatment might influence the course and therefore the results of the study. Thus it is particularly important that the study physician is blinded to treatment if the endpoints are subjective. Blinding of patients to their treatment is important, for example, if their attitude could potentially affect their reliability in taking the test medication (compliance) or even their response to treatment. …

In clinical research, randomized controlled trials are the gold standard for demonstrating the efficacy and safety of a new treatment.

[32] Paper: “A Reanalysis of the High/Scope Perry Preschool Program.” By James Heckman and others. University of Chicago, January 22, 2010. <www.researchgate.net>

Page 2: “The High/Scope Perry Preschool program, conducted in the 1960s, was an early childhood intervention that provided preschool to low-IQ, disadvantaged African-American children living in Ypsilanti, Michigan, a town near Detroit.”

Page 2: “The study was evaluated by the method of random assignment.”

Page 3: “The sample size is small: 123 children allocated over five entry cohorts.”

Page 4:

The eligibility rules for participation were that the participants (1) be African-American; (2) have a low IQ (between 70 and 85) at study entry,⁶ and (3) be disadvantaged as measured by parental employment level, parental education, and housing density (people/room). The Perry study targeted families who were more disadvantaged than other African-American families in the U.S. but were representative of a large segment of the disadvantaged African-American population. …

Among children in the Perry Elementary School neighborhood, Perry program families were particularly disadvantaged. Table 1 shows that compared to other families with children in the Perry School catchment area, Perry program families were younger, had lower levels of parental education, and had fewer working mothers. Further, Perry program families had fewer educational resources, larger families, and greater participation in welfare, compared to the families with children in another neighborhood elementary school in Ypsilanti (the Erickson School).

⁶ Measured by the Stanford-Binet IQ test (1960s norming), which has approximate mean of 111 and standard deviation of 16 at study entry (ages 3–4).

Pages 35–36:

Comparability in later life outcomes between the restricted group and the Perry control group suggests that the Perry sample, while not necessarily representative of the African-American population as a whole, is representative of a particular subsample of that population. Specifically, this subsample reflects the eligibility requirements of the Perry program, such as low IQ of the child and a low parental SES [socio-economic status] index.

The US population in 1960 was 180 million people, of which 10.6% (19 million) were black.⁵² We use the NLSY79 [1979 National Longitudinal Survey of Youth] a representative sample of the total population that was born between 1957 and 1964, to estimate the number of persons in the US that resemble the Perry population at entry (age 3). According to the NLSY79, the black cohort born in 1957–1964 is composed of 2.2 million males and 2.3 million females. We estimate that 17% of the male cohort and 15% of the female cohort would be eligible for the Perry program if it were applied nationwide. This translates into a population estimate of 712,000 persons out of this 4.5 million black cohort resemble the Perry population.⁵³ For further information on the comparison groups and their construction, see Web Appendix I and Tables I.1 and I.2 for details.

CALCULATION: (712,000 / 4,500,000) × 10.6% = 1.7%

[33] Paper: “Biomarkers and Surrogate Endpoints in Clinical Trials.” By Thomas R. Fleming and John H. Powers. Statistics in Medicine, June 18, 2012 <onlinelibrary.wiley.com>

One of the most important considerations in designing clinical trials is the choice of outcome measures. These outcome measures could be clinically meaningful endpoints that are direct measures of how patients feel, function, and survive. …

The most important characteristic in guiding the selection of the primary endpoint in definitive trials is that effects on such an endpoint should provide reliable evidence about whether the intervention provides clinically meaningful benefit. …

Level 1: A true clinical efficacy measure … death … hospitalization … stroke … symptomatic myocardial infarction … pain … bone fractures

[34] Paper: “Biomarkers and Surrogate Endpoints in Clinical Trials.” By Thomas R. Fleming and John H. Powers. Statistics in Medicine, June 18, 2012 <onlinelibrary.wiley.com>

Alternatively, indirect measures, such as biomarkers that include physical signs of disease, laboratory measures, and radiological tests, often are considered as replacement endpoints or ‘surrogates’ for clinically meaningful endpoints. …

However, most indirect measures to be considered in this article do not have such dependence. Rather, they are measurements of biological processes. They will be called biomarkers, and ‘include physiological measurements, blood tests and other chemical analyses of tissue or bodily fluids, genetic or metabolic data, and measurements from images’¹⁰.

Level 4: A correlate that is a measure of biological activity, but not established to be at a higher level. … Antibody levels and cell mediated immune responses … Negative cultures and polymerase chain reaction tests, in treating various infectious diseases

We should carefully consider the consequences of relying on biomarkers as surrogate endpoints and thus as the primary source of efficacy information when determining whether interventions should be used in clinical practice. Such reliance has the benefit of allowing clinical trials for regulatory approval to be smaller in size and shorter in duration.

[35] Paper: “Biomarkers and Surrogate Endpoints in Clinical Trials.” By Thomas R. Fleming and John H. Powers. Statistics in Medicine, June 18, 2012 <onlinelibrary.wiley.com>

We provide insight into why indirect measures such as biomarkers may fail to provide reliable evidence about the benefit-to-risk profile of interventions. …

Another factor complicating the reliability of an evaluation of efficacy based on biomarkers, as illustrated in Figure 3, is the likelihood that these measures do not capture important off-target effects of the intervention, even though such effects could meaningfully alter the true clinical efficacy of the intervention. There are numerous examples where biomarkers have failed for this reason^{8, 10, 11}. A classic example arose when over a quarter million US patients annually were provided encainide and flecanide to suppress their arrhythmias post myocardial infarction, because of the increased risk of sudden death in patients with arrhythmia. Eventually, the 2000-patient placebo-controlled Cardiac Arrhythmia Suppression Trial was completed. Many were stunned by the trial results that revealed the two anti-arrhythmia agents actually tripled the death rate, likely because of off-target effects not captured by the suppression of the arrhythmia biomarker,^{17, 18}. …

It should not be surprising, then, that agents receiving regulatory approval using efficacy assessments based on surrogate endpoints are more vulnerable to having clinically unacceptable safety issues discovered during the post-marketing period. …

The concerns about a biomarker-based approach for evaluating agents become greater when recognizing that the determination of the threshold for acceptable safety risks depends on the strength of evidence regarding efficacy. Thus, not only does the biomarker-based approach provide an increased likelihood that safety signals will not be discovered until post-marketing, there is much greater risk that such signals, when discovered, cannot readily be justified to be acceptable within the context of the strength of evidence regarding efficacy.

[36] Book: The Creation of Matter. By Harald Fritzsch. Basic Books, 1984. Page 17.

[37] Articles: “Coronavirus Updates: C.D.C. Recommends 2 Covid Vaccines for Very Young Children.” New York Times, June 18, 2022. <www.nytimes.com>

“This is an opportunity that one does not get very often: the prevention of children’s deaths. We know this disease is killing children,” said Dr. Beth Bell, a member of the C.D.C.’s Advisory Committee on Immunization Practices. “And we can help prevent those deaths through this vaccine.”

NOTE: This series of eight New York Times articles about the CDC’s recommendation to inject “all children 6 months and older” with Covid-19 vaccines reveals nothing about the fact that the studies that underlie this decision used antibody levels as their primary measure of efficacy. See the second footnote below for the vital implications of this.

[38] Article: “Coronavirus Vaccines for Kids Under 5 Are Finally Here.” By Lena H. Sun and Joel Achenbach. Washington Post, June 18, 2022. <www.washingtonpost.com>

“This is an opportunity which one doesn’t get very often to participate in preventing the death of children, of young children,” said panel member Beth Bell, a global health professor at the University of Washington, following a two-day meeting that concluded Saturday. …

NOTE: This Washington Post article about the CDC’s “recommendation to vaccinate all children as young as 6 months old with one of two” Covid-19 vaccines reveals nothing about the fact that the studies that underlie this decision used antibody levels as their primary measure of efficacy. See the footnote below for the vital implications of this.

[39] Article: “FDA Violated Own Safety and Efficacy Standards in Approving Covid-19 Vaccines For Children.” By James D. Agresti. Just Facts, July 14, 2022. <www.justfactsdaily.com>

Antibody Tests Should Not Be Used

In a May 2021 “Safety Communication,” the FDA warned the general “public and health care providers” that:

currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity or protection from Covid-19 at any time, and especially after the person received a Covid-19 vaccination.

If the results of the antibody test are interpreted as an indication of a specific level of immunity or protection from SARS-CoV-2 infection, there is a potential risk that people may take fewer precautions against SARS-CoV-2 exposure.

Violating that principle, the FDA’s June 2022 press release announcing emergency approval of the Moderna and Pfizer Covid vaccines for young children repeatedly insists the vaccines are effective because they create a certain “immune response.” How is this immune response measured? Other FDA documents reveal that the:

• Pfizer vaccine “effectiveness was inferred” in children aged 6 months to 4 years from “antibody” tests.
• Moderna vaccine “effectiveness in individuals” aged 6 months to 11 years “is based” on “antibody” tests.

In other words, the FDA approved these vaccines using a measure that it denounced a year ago. …

Worse still, the antibodies measured in both the Moderna and Pfizer trials are not for Omicron variant, which now accounts for 100% of Covid infection in the United States. Instead, the trials measured antibodies for “USA-WA1/2020,” a variant that “closely resembled the original Wuhan strain.” Because this variant is no longer in circulation, and the vaccines are narrowly targeted to it, these studies are materially outdated.

In short, the FDA approved these Covid-19 vaccines for children by using a subpar, inexpensive, indirect, and outdated measure of how children fared instead of a clinically meaningful one. The hazards of this approach are compounded by the next issue.

Children Are Not Small Adults

In an October 2021 press release in which the FDA announced that it was holding meetings to discuss approving Covid-19 vaccines for children aged 5–11, acting FDA Commissioner Janet Woodcock stated:

We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults.

In that statement, the FDA acknowledged that the developing bodies of children are very different from adults, and therefore, it is dangerous to extrapolate the results of studies on adults to children. Instead, comprehensive studies on children of varying ages are needed to be sure any benefits of a vaccine outweigh its harms.

Violating that standard, the FDA’s June 2022 press release announcing emergency use approval of the Moderna and Pfizer Covid-19 vaccines for children down to 6 months of age claims that the vaccines are effective and safe for these children because:

• “available safety surveillance data from the U.S. and other countries on myocarditis outcomes—which the FDA admits “are not available” for “the age group of 6 months through 4 years”—“continue to strengthen the evidence that most cases of myocarditis associated with the Moderna and Pfizer-BioNTech Covid-19 vaccines” typically don’t cause long-term harm.

• “the immune response of the children to the [Moderna] vaccine was comparable to the immune response of the adults.”

• “the immune response to the [Pfizer] vaccine for both age groups of children was comparable to the immune response of the older participants.”

Why did the FDA cite data from adults and older children in a press release for younger children? Because the studies on younger children were often too small to directly measure any potential benefits and risks from the vaccines, much less clinically meaningful ones like preventing hospitalization and death. The press release partly admits this by stating:

• Among children aged 6–11 years in the Moderna vaccine trials, an FDA “analysis pertaining to the occurrence of Covid-19 cases was determined not to be reliable due to the low number of Covid-19 cases that occurred in study participants.”

• Among children aged 6 months to 4 years in the Pfizer vaccine trials, FDA analyses “pertaining to the occurrence of Covid-19 cases was determined not to be reliable due to the low number of Covid-19 cases that occurred in study participants.”

An FDA briefing document admits something even more revealing about the Moderna clinical trials on children of all ages:

• “There were no reports of severe Covid-19 cases in participants 6–23 months of age in this study as of the data cutoff.”
• “There were no reports of severe Covid-19 cases in participants 2–5 years of age in this study as of the data cutoff.”
• “No cases of severe Covid-19 were reported among study participants 6–11 years of age.”
• “There were no reports of severe Covid-19 cases in participants 12–17 years of age.”

In other words, the trials were so small that not a single child who received a placebo or vaccine had a severe case of Covid-19. The same was true of the Pfizer trials for children aged 6 months to 4 years, 5–11 years, and 12–15 years.

Yet, when the FDA approved this vaccine for children, FDA Commissioner Robert Califf claimed:

As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of Covid-19, such as hospitalization and death.

Given the fact that no child had severe Covid-19, that statement is a clear violation of the tenet that “children are not small adults.”

Severely Underpowered

Even more troubling, a June 2022 FDA review memorandum for approval of the Pfizer vaccine in children aged 6 months to 4 years states the following in convoluted language buried at the end of long paragraph 57 pages into the document:

From Dose 1 through the data cutoff, 1 placebo recipient 6–23 months of age and 7 participants 2–4 years of age (6 BNT162b2 [Pfizer vaccine] recipients and 1 placebo recipient) met the criteria for severe Covid-19, with only one hospitalization for severe Covid-19 disease in a BNT162b2 recipient 99 days post-Dose 2.

In plain language, this means that contrary to the FDA commissioner’s claim that the vaccines will “provide protection from the most severe outcomes of Covid-19”:

• 6 children who received the vaccine experienced a severe case of Covid-19, compared to only 2 who received the placebo.
• 1 child who received the vaccine was hospitalized for severe Covid-19, compared to zero who received the placebo.

People who rely on the New York Times for such information are under the opposite impression and are unlikely to ever learn the truth. This is because:

• the FDA’s knotty verbiage, which it also used in another document, led the Times to misreport that “eight children in the placebo group and two in the vaccinated group fell ill.”
• Just Facts notified the editors of the Times and the reporter (Sharon LaFraniere) of their error on June 29.
• the Times has failed to correct it as of July 13.

Because two children received the vaccine for every one who received the placebo in this trial, those figures imply more parity than the raw numbers reveal. But even after accounting for this by doubling the placebo cases, these results provide no indication the vaccine prevents severe Covid-19.

That doesn’t mean the vaccine doesn’t work, but there is no way to be sure. This is because the study was underpowered, a medical term for clinical trials that don’t enroll enough participants to detect important effects. Beyond severe Covid and hospitalizations for it, the Pfizer and Moderna trials were also too underpowered to measure:

• overall hospitalizations, which are far more informative than hospitalizations for Covid because they also measure the side effects of the vaccines.
• all-cause mortality, which is the only objective way to be certain the vaccines save more lives than they take.

To determine the last of those measures with 95% confidence would require a trial with more than half a billion children for a full year. And that assumes the vaccine works flawlessly by preventing all Covid deaths and causing no deaths from side effects. This astronomically large number is needed because deaths from Covid-19 are extremely rare among children, amounting to about one out of every 500,000 children in the first year of pandemic. In fact, children are about 36 times more likely to die of accidents than Covid-19.

Microscopically smaller than an adequate study, the Moderna vaccine trials for children aged 6 months to 5 years included a total of 6,388 children with a median blinded follow-up time of 68–71 days after the second dose. The Pfizer trial was similarly sized.

Comparing the data above, the trials that were conducted would need to be about 400,000 times larger/longer to objectively determine if the vaccines save more toddlers and preschoolers than they kill.

[40] Paper: “Comparisons of Exacerbations and Mortality Among Regular Inhaled Therapies for Patients with Stable Chronic Obstructive Pulmonary Disease: Systematic Review and Bayesian Network Meta-Analysis.” By Hyun Woo Lee and others. PLoS Medicine, November 15, 2019. <journals.plos.org>

Mortality is the most important outcome in various acute and chronic diseases, including COPD [chronic obstructive pulmonary disease]. …

COPD treatments can have both beneficial and harmful effects on COPD-related outcomes and other comorbidity-related outcomes. …

The probability of all-cause mortality was evaluated in 190 RCTs [randomized controlled trials] involving 221,451 patients (Fig 4). Compared with the patients who received a placebo, the patients who received ICS [inhaled corticosteroids ] / LAMA [long-acting muscarinic antagonists] / LABA [long-acting beta-agonists] and ICS/LABA showed a significantly higher probability of reduced mortality….

The optimal treatment for patients with multivessel coronary artery disease (MVD) remains controversial. Coronary artery bypass grafting (CABG) has been longer considered the treatment of choice in MVD. However, the introduction of drug eluting stents (DES) has dramatically reduced the incidence of in-stent restenosis thus improving outcomes after percutaneous coronary intervention (PCI) [1]. DES-PCI has increasingly been used to treat this group of patients in recent years. Despite several randomized controlled trials (RCTs) comparing DES-PCI versus CABG have been recently published, these studies are individually underpowered to detect a difference in all-cause mortality, the most important outcome in cardiovascular trials [2], [3]. Similarly, these trials were also underpowered to detect differences in myocardial infarction (MI), a major cause of morbidity in these patients [2], [3]. Given no clear superiority of surgical treatment with regard to mortality and MIs, and given an increase in strokes with CABG, DES-PCI is often preferred in MVD [4].

[41] Paper: “Empirical Atypical Coverage for Inpatients With Community-Acquired Pneumonia.” By Daphna Shefet and others. JAMA Internal Medicine, September 26, 2005. <jamanetwork.com>

The objective of our review was to assess empirical antibiotic coverage of atypical pathogens in hospitalized patients with CAP [community-acquired pneumonia], in terms of mortality and successful treatment. …

Although mortality is the most significant outcome in a potentially lethal infection, all studies chose clinical failure as their primary outcome. This end point is subjective and should be studied with care. Our review clearly demonstrates its potential for bias. … Thus, we should be wary about relying solely on subjective outcomes when comparing treatment regimens for pneumonia, especially because pharmaceutical companies sponsored most studies and many studies were nonblinded.

[42] Paper: “Effectiveness and Safety of Adjunctive Inhaled Antibiotics for Ventilator-Associated Pneumonia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.” By Rui Tang and others. Journal of Critical Care, October 2021. <www.sciencedirect.com>

The efficacy and safety of adjunctive inhaled antibiotic therapy for ventilator-associated pneumonia (VAP) was systematically reviewed based on updated studies. …

We searched four databases and four clinical trial registration platforms to identify relevant studies published prior to May 19, 2020. Randomized controlled trials (RCTs) assessing adjunctive antibiotic inhalation treatment for VAP patients were eligible for this review. …

Adjunctive inhaled antibiotics improved the clinical outcomes in VAP patients, but the increased rates clinical cure and microbiological eradication were not associated with reduced mortality. The use of nebulized antibiotics is not supported by the currently available evidence as a routine therapeutic strategy for VAP. …

… Therefore, the most objective outcome, all-cause mortality, was selected as the primary outcome.

[43] Paper: “Efficacy and Safety of Baricitinib for the Treatment of Hospitalised Adults with Covid-19 (COV-BARRIER): A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Trial.” By Vincent C. Marconi and others. The Lancet Respiratory Medicine, December 2021. <www.sciencedirect.com>

This study evaluates the efficacy and safety of baricitinib in combination with standard of care for the treatment of hospitalised adults with Covid-19. …

Although there was no significant reduction in the frequency of disease progression overall, treatment with baricitinib in addition to standard of care (including dexamethasone) had a similar safety profile to that of standard of care alone, and was associated with reduced mortality in hospitalised adults with COVID-19. …

All-cause mortality is the most relevant outcome in trials of patients hospitalised for Covid-19, and baricitinib plus standard of care showed a meaningful reduction in mortality compared with placebo plus standard of care, most notably for participants receiving high-flow oxygen or non-invasive ventilation.

[44] Paper: “Does Fecal Occult Blood Testing Really Reduce Mortality? A Reanalysis of Systematic Review Data.” By Paul Moayyedi and Edgar Achkar. American Journal of Gastroenterology, February 2006. <journals.lww.com>

Colorectal cancer (CRC) is a common cause of cancer mortality. A variety of CRC screening strategies are being adopted in many developed countries. Fecal occult blood testing (FOBT) is one option for screening that has the most evidence for efficacy and is also the cheapest approach. Systematic reviews suggest that FOBT is effective in reducing CRC mortality but the data on overall mortality from any cause has rarely been synthesized.

Methods

Randomized controlled trials identified by a Cochrane review of the efficacy of FOBT were reanalyzed. Trials that reported on biennial FOBT with all cause mortality assessed at similar follow-up periods were analyzed. CRC, non-CRC, and all cause mortality were evaluated using a random effects model.

Results

Three trials were analyzed, involving 245,217 subjects with 2,148 CRC deaths after almost 3 million patient-years follow-up. The relative risk (RR) of CRC death in the FOBT arm was 0.87 (95% CI = 0.8–0.95). The RR of non-CRC death in the FOBT group was 1.02 (95% CI = 1.00–1.04, p= 0.015). The increase in non-CRC in the FOBT group balanced the decrease in CRC mortality with no overall impact on mortality (RR of dying in the FOBT arm = 1.002, 95% CI = 0.989–1.015).

Conclusion

The impact of FOBT in reducing mortality from any cause is uncertain and efficacy of this strategy for CRC screening needs reevaluation.

[45] Paper: “Coronary Surgery Is Superior to Drug Eluting Stents in Multivessel Disease. Systematic Review and Meta-Analysis of Contemporary Randomized Controlled Trials.” By Umberto Benedetto and others. International Journal of Cardiology, May 1, 2016. <www.sciencedirect.com>

Current randomized controlled trials (RCTs) comparing percutaneous coronary intervention with drug eluting stent (DES-PCI) with coronary artery bypass grafting (CABG) in multivessel disease are underpowered to detect a difference in hard clinical end-points such as mortality, myocardial infarction and stroke. We aimed to overcome this limitation by conducting a meta-analysis of contemporary RCTs. …

In patients with multivessel coronary disease, CABG was found to be superior to DES-PCI by reducing the risk of mortality and subsequent myocardial infarction at the expense of a marginally increased risk of stroke.

[46] Paper: “Characteristics of Cluster Randomized Trials: Are They Living Up to the Randomized Trial?” By Senthil Selvaraj and Vinay Prasad.. JAMA Internal Medicine, February 25, 2013. <jamanetwork.com>

Cluster randomized control trials (RCTs) are a form of prospective study where groups of individuals are allocated to an intervention. They offer the unique advantage of rigorously evaluating practices that cannot feasibly be randomized to the individual—such as public health or quality programs. …

Highly cited cluster RCTs did not examine mortality as an end point as often as traditional RCTs (26% vs 80%; P < .001), whereas recent studies examined mortality in equal numbers (12% vs 8%; P = .74). …

Meanwhile, cluster RCTs should more often assess mortality, a hard and important end point, to match their RCT counterparts.