An evidence-based, slide-by-slide critique exposing bias, omissions, and fallacies
First published Feb. 18, 2022 on Lara Gabriel’s sub-stack Lara Gabriel RN. Republished with permission.
The Washington State Department of Health is meeting on 2/10, 2/17 and 2/24 to discuss adding the COVID-19 experimental products to the vaccine schedule for children to attend school and day care. They are being advised by a Technical Advisory Group (TAG) evaluating nine criteria. I will be responding only to criteria #6 in this post. Please see this post by my colleague, Dr. Zana Carver, for her response to criteria #5.
In brief, the TAG presentation on criteria #6 shows a substantial lack of evidence to support a “Yes” vote and overwhelming evidence to support a “No” vote. The presentation included NO data for transmission among school-age children and those in daycare according to their vaccine status, yet expected the members to vote on this without any evidence presented. Twelve out of seventeen members voted yes, despite NO evidence. The TAG team’s 12 out of 17 “yes” majority vote in the face of non-existent evidence is alarming.
I care deeply about the health and safety of my fellow citizens. Mandating covid shots for kids might be understandable if scientific evidence supported the hypothesis that the injections were safe and could save many lives. Unfortunately, the science clearly shows that covid shots for healthy kids carry high risk, with no benefit over natural immunity.
We must also consider the national context and public opinion for our state’s decision. Seventeen states (in purple in the map below) have banned adding covid shots to the school schedule. The majority of families oppose K-12 Covid shot mandates.
Before focusing on criteria #6, we must step back and question underlying assumptions in order to understand the lack of evidence for adding this shot to the school schedule. For simplicity, I refer to SARS-CoV2 and associated illness by the shorter, popular-use term “Covid.”
Are healthy children at significant risk from Covid transmission? No.
Unlike other vaccine-targeted diseases, infection with Covid in children ranges from asymptomatic to mild cold-like symptoms. Overall deaths or severe illness in children is very rare. According to CDC data, children have a statistically nil incidence of death due to Covid. Children also have very low rates of hospitalizations associated with Covid. Note that rates of hospitalized children WITH a positive PCR test versus hospitalization DUE TO Covid is not tracked by CDC or any state agencies. The CDC only tracks “Covid-19-associated hospitalization rates.” This metric means a hospitalization for any reason, plus a positive PCR test, which is universally given to all patients on admission. This murky metric is misleading and fear-mongering, and unhelpful for policy-making.
Can we create policy based on clinically misleading PCR tests? No.
Why is discussion of natural immunity lacking in the TAG presentation, and is vaccinating children against transmission of Covid even a goal worth pursuing?
Playing whack-a-mole with case counts as a policy metric may not be the best strategy for an endemic virus with a low case rate fatality and a preponderance of asymptomatic or mild illness. Instead, we must seek to understand the protective effect for the community of allowing children to develop natural immunity, with characteristically mild or asymptomatic infection, as a robust and long-lasting contribution to herd immunity. The goal of herd immunity from the mRNA injections has failed. 2022 might be the year we begin to embrace natural immunity and reasonable risk to live with Covid, as we adapt from a pandemic to an endemic mindset. Case fatality rate and hospitalizations are decreasing, and we can expect continued decrease of disease burden with increasing knowledge, improvements in early home treatment, therapeutics, and spreading immunity. We may also look forward to more accurate risk analysis if there is more transparency and stratification in reporting of data Current hospital data lacks the distinctions of being hospitalized WITH Covid versus being hospitalized DUE TO Covid, or ICU hospitalizations versus general-admission hospitalizations. Zero Covid is an impossible goal, and we may shift to acceptance of reasonable risk, just as we do with other seasonal endemic respiratory viruses. Prominent public health advocates are calling for living with Covid as the new normal. Evolving milder variants, improvements in prevention, early home treatment and therapeutics, and high rates of natural immunity in the younger generation could make childhood vaccine mandates unnecessary. The majority of the public opposes covid shot mandates for school children and daycare.
Do covid shots stop the spread of SARS-CoV2? No.
Despite early reports of some efficacy, it is becoming clear that subsequent variants have rendered the vaccine ineffective at stopping covid spread. For vaccination to be effective, it must either reduce the likelihood of a person becoming infected, or reduce the likelihood of a vaccinated and infected person infecting another person. Multiple studies show that covid shots are ineffective at preventing transmission of Omicron, including
- In December, 2021, Pfizer stated that its product shows substantially reduced efficacy against the Omicron variant.
- The NIFB Supreme Court Amicus brief describes “Real-world evidence from at least four countries with significant experience with Omicron — Denmark, the United Kingdom, Germany, and Canada, all of which provide more detailed and transparent data than has been made available in the United States — evidences that these vaccines have substantially zero efficacy at preventing Omicron transmission (p. 19-26).”
- Other studies from Denmark and Scotland show negative efficacy, meaning vaccination increases risk of illness.
- Across the United States, vaccination rates are not related to case rates or to decreased Covid transmission within households
- Covid shots fail to decrease the viral load of infected individuals.
- Countries with some of the highest Covid vaccination rate are showing the steepest rise in Covid infections, such as Netherlands, Seychelles, the UAE, Chile and Bahrain. In contrast, Africa has both the lowest vaccination and lowest Covid infections. This global pattern raises serious questions about whether covid shots are an effective tool for stopping Covid illness.
- What about early home treatment protocols?The majority of Covid illness can be treated effectively at home with proven, safe, multi-drug protocols for early home treatment. If more persons had access to early home treatment, then hospitalization and serious disease rates would be lower.
How do definitions of vaccinated and unvaccinated persons bias evidence?
A death within 14 days post-injection is counted as an unvaccinated death. This inflates the unvaccinated death rate and hides the death rates due to Covid shots. The vast majority of deaths from Covid shots occur within the first two weeks. The CDC also has two different sets of testing guidelines — one for vaccinated patients and another for the unvaccinated. If you are unvaccinated, CDC guidance says to use a cycle threshold (CT) of 40, known to result in false positives. If you’re vaccinated, they recommend using a CT of 28 or less, which minimizes the risk of false positives. The CDC also hides vaccine failures by only counting breakthrough cases that result in hospitalization or death.
Is there any evidence of acceptable efficacy demonstrated in the Pfizer trials for children under 5? No.
An unbiased TAG presentation must include this evidence of vaccine efficacy failure in the Pfizer trials. In young children, the shots appear to be falling far short of the minimum 50% efficacy standard for vaccines set by the FDA.
What is the risk-benefit analysis for kids?
From VAERS, the risk to children of adverse vaccine reactions appears unacceptably high for a disease with a relatively low risk of serious illness in children. The risk-benefit analysis clearly favors natural immunity and avoiding widespread use of mRNA vaccines in children until we have more data. We must remember our ethical mandate to
“First, do no harm.”
Slide-by-slide rebuttal of the conclusions reached by the TAG on 2/10 evalutation of criteria #6:
Slide 1: “Methods”
- Author admits unacceptable gaps in the data on which to base evaluation of criteria #6
- There are no studies included on Covid transmission in schools between vaccinated and unvaccinated school-aged children. Therefore, there is no data to support a “yes” vote on criteria #6
- As the author admits, the information presented is based on studies of adult participants, which is not a representative population for evaluating school and childcare transmission.
- Children are not miniature adults. As any pediatrician will tell you, children have distinctive cellular and functional differences in their immune systems. A Lancet paper on this difference concludes that in “situations such as the COVID-19 pandemic, the investigation and use of immune tools that nature has endowed to children might improve management outcomes.”
- Consider this in-depth discussion of how the definition of vaccinated and unvaccinated persons skews results toward worse outcomes for “unvaccinated” (these two categories entail gray areas of dose and time intervals, not black and white distinctions),
- The cited studies are based on adults and the Delta variant, which are not relevant evidence for the evaluation criteria. Data on current and emerging variants is needed, or the recommendation should be to vote “no” and delay decision-making.
- Would you suggest vaccinating children against influenza with 2020 strains for a 2023 strain of flu? Vaccinating children with the Pfizer vaccine is equivalent to using a three-year-old flu shot, with no studies on efficacy with current flu variants.
Slide 2: “Vaccines can prevent transmission in two ways”
- As the author states, “transmission from asymptomatic persons may not be considered” (in vaccine efficacy).
- The vast majority of cases in children are asymptomatic.
- Efficacy requires a recognizable infection which requires an accurate test. The CDC has withdrawn the Real-Time RT-PCR Diagnostic Panel test.
- We do not have accurate testing for Covid. We have mainly asymptomatic cases in children. Therefore, we lack evidence to evaluate transmission or vaccine efficacy. The answer to whether the covid shot meets the nine criteria is, “We just don’t know.”
- All of the above on slide 2 supports a “no” vote on criteria six.
Slide 3: Title “Epidemiologic curve of variants being monitored and variants of concern in Washington by week of specimen collection date from January 01, 2021 to January 15, 2022”
- This chart underscores the fact that cited studies and vaccine development are based on obsolete variants. We have no evidence to evaluate the use of a 2020 vaccine on the current, rapidly evolving landscape of variants, which appear to be following Farr’s Law and producing infections in children progressing from mild in Delta to very mild with omicron.
- All of the above on slide 3 supports a “no” vote on criteria six.
Slide 4: “Viral Dynamics of Covid Variants in Vaccinated and Unvaccinated Persons”
- A study, based on healthy adult men basketball players, with three 2020-2021 era variants
- Results: “Found no meaningful difference in the level of viral load or persistence of the virus between vaccinated and unvaccinated participants”
- This slide supports that we do not have evidence to support Criteria Six. All of the above on slide 4 supports a “no” vote on criteria six.
Slide 5: Effect of Covid-19 Vaccination on Transmission of Alpha and Delta Variants
- This slide is not relevant to the question because it describes a study of adult transmission with Alpha and Delta variants.
- “The effects of vaccination decreased over time” is evidence of the waning, temporary, short-term vaccine immunity that skews the risk-benefit analysis toward not adding this shot to the school immunization schedule.
- All the above on slide 5 supports a “no” vote on criterion six.
Slide 6: “Data on COVID-19 Transmission by Vaccinated Individuals”
- Author mentions “Waning immunity over 3 months.” There is additional evidence that vaccine-induced immunity wanes over a few months, and may return to pre-vaccine levels. Pfizer trials in young children were extended to study a third shot due to low rates of antibody response in younger children.
- We must question the risk of imposing a school mandate on children with a vaccine that carries irreversible risk in exchange for a vaccine-mediated immunity with a rapidly waning, temporary antibody response for a disease that entails minimal risk to children.
- We must consider the lower-risk, longer-lasting option of natural immunity for school children.
- The cited study conclusions are not a definitive finding on any differences in viral load of vaccinated and unvaccinated persons due to absence of microbiological studies to confirm findings.
- This study supports the “greater reduction in transmission in earlier variants, leading to reasonable assumption that transmission reduction may be low or non-existent effect in current and evolving variants.” This supports NOT vaccinating children.
- “Vaccinated people infected with the delta variant can carry detectable viral loads similar to those of people that are unvaccinated.” This supports NOT vaccinating children.
- The study on this slide focuses on severe disease. This is not relevant to all school children because children are not at risk for severe disease from Covid so they do not need a mandated vaccine. This choice is best left to individual families who may still choose to vaccinate children with underlying conditions who may be at risk of severe disease.
- Recent studies by allergists show that children with asthma and allergies have a much lower number of ACE-2 receptors, which has been found to be protective against severe disease with COVID. This re-categorizes a large category of children previously thought to be high risk.
- “Unlike delta, omicron seems to cause much higher numbers of breakthrough cases in vaccinated people.” (This is irrelevant to the question, because cases do not equal illnesses. Illnesses do not equal hospitalizations. Eliminating cases is not, in itself, a reason to mandate vaccinations for school children for an endemic virus.
- This slide illustrates that our understanding of the role of vaccines in preventing person-to-person transmission of COVID-19 in congregate settings such as schools is still evolving. So, there is not sufficient evidence to meet the criteria.
- All of the above on slide 6 supports a “no” vote on criteria six.
Slide 7: Title: “Centers for Disease Control and Prevention talking points on Transmission of Covid in K-12 Schools and Early Care and Education Programs”
- If we have a 70.4 percent voluntary rate of fully vaccinated persons 12 and older, is a school mandate necessary?
- There is no supporting evidence for the talking point “Increasing COVID-19 vaccination rates will likely affect patterns of transmission in schools and communities.”
- “The introduction of new variants of the virus into the population likely will further affect the evolving epidemiology and interpretation of future studies as will understanding how transmission varies by the age of the child.” This statement supports a “No” vote because it shows more lack of evidence to support the criteria on transmission. Again, the evidence and lack of evidence points to “We just don’t know.”
- The landscape of the virus and the population is evolving, transmission and risk are both age-stratified issues, and we simply do not know enough about patterns of transmission to support an experimental use authorization of a novel technology that may do more harm than good.
- “In Michigan and Washington state, delivery of in-person instruction was not associated with increased spread of Covid in schools when community transmission was low, but cases in schools did increase at moderate-to-high levels of community transmission. When community transmission was low, there was no association between in person learning and community spread.8”
- A reading of the entire study shows significant limitations and inconclusive findings which makes any evidence from this study dubious for the purpose of evaluating criteria six. The limitations discussion includes, “ Event studies in Washington are quite imprecise, but they do not suggest the same increase in COVID spread stemming from districts’ initial reopening.” we hesitate to offer specific recommendations about exact case rate thresholds. This is because, as with any econometric model, there is uncertainty in our estimates…
- The CALDER study relies mainly on 2020 and early 2021 data and is not relevant to the current conditions. In Washington State with a high percentage of vaccinated adults, and evolving milder variants, we can expect continued low community transmission.
- The author had made an error in citation, citing reference number 8 for the statements on this slide, which is a preprint from China, not the CALDER study. This citation error undermines the authority of the presentation.
- All of the above on slide 7 supports a “no” vote on criteria six.
Slide 8: Title: “COVID-19 infection and vaccine effectiveness – community surveys in England”
- Delta variant is referenced in the study. This study is not relevant to 2022 policy.
- Conclusions from the REACT study that support a “No” vote on the transmission criteria: “an estimate of vaccine effectiveness against infection of 63% from REACT-1 rounds 13 and 14, when the delta variant dominated… vaccine effectiveness is specific to population and time so these estimates reflect the performance of the vaccines in England during a specific time period (ie, June–September, 2021). Since then, the omicron (B.1.1.529) variant had become dominant in England by December 2021, with studies by UK HSA indicating lower vaccine effectiveness against symptomatic infection for omicron compared to delta”
- Study states “breakthrough infections following two-dose vaccination might increase after 3–6 months” which acknowledges rapidly waning effectiveness of the vaccine and supports a “no” vote on criteria six.
- Cited study states, “As of Sept 27, 2021, only 1214 (6·3%) children aged 12–17 years had been vaccinated in the REACT-1 study, thus not allowing a meaningful extension of our vaccine effectiveness analyses to that age groupin round 14” Further studies of vaccine effectiveness are warranted given the rapid increase in omicron infections in England beginning in December, 2021.” Again, this supports a “no” vote on criteria six.
- A further limitation is that we do not have accurate data on the vaccination status of all participants. “Not all participants consented for linkage to their NHS records.” Study results were obtained using RT-PCR swab positivity data, and this is based on assumption that PCR test has a meaningful sensitivity and specificity for Covid, which is in doubt. Again, the cited study supports the conclusion that we do not have enough reliable evidence and supports a “no” vote on criteria six.
- The CDC defines prevalence as “the proportion of persons in a population who have a particular disease or attribute at a specified point in time or over a specified period of time”. This study defines prevalence by self-administered or parent-administered PCR testing not clinical signs, in patients who may, or may not, exhibit disease symptoms. Prevalence depends on test accuracy. Tests may or may not be accurate. Prevalence measurement necessitates that a disease is clinically well- defined. There is not enough evidence of a clinically well-defined illness to support using prevalence as evidence on transmission.
- All of the above on slide 8 supports a “no” vote on criteria six.
Slide 9: Title: “Transmission dynamics and epidemiological characteristics of Delta variant infections in China”
- This study is not relevant to evidence for our question since it is deals with China, Delta and adults. The applicability and transferability of research from two very different countries is questionable.
- This study is a preprint, not peer reviewed, and accuracy of data is limited by dependence on accuracy of contact tracing methods.
- All of the above on slide 9 supports a “no” vote on criteria six.
Slide 10: “Virological and serological kinetics of Covid Delta variant vaccine-breakthrough infections: a multi-center cohort study”
- Uses PCR cycle threshold as a proxy for viral load, this is not a definitive finding on any differences in viral load of vaccinated and unvaccinated person. The absence of microbiological studies to confirm findings makes the results irrelevant. Per the CDC, “Cycle threshold values should not be used to determine an individual’s viral load, how infectious an individual person may be, or when an individual person can be released from isolation or quarantine.”
- Study involves adults, and many much older adults which are not relevant to school children.
- This is another preprint, not a peer-reviewed study.
- Study acknowledges high rate of infections in the vaccinated group (breakthrough infections), which supports evidence of low vaccine effectiveness in transmission.
- All of the above on slide 10 supports a “no” vote on criteria six.
Slide 11 “Effectiveness of Pfizer Vaccine against Omicron Variant in South Africa”
- Study and slide states “These measures of vaccine effectiveness were significantly different.
- Showed that Omicron was better at escaping antibody neutralization by the Pfizer vaccine”
- All of the above on slide 11 supports a “no” vote on criteria six.
A summary of excluded critical issues in the TAG presentations to date which creates an appearance of bias:
- Omicron variant in children is very mild and very low-risk
- Exaggerated risk of multi-system inflammatory syndrome MSIC-V (which is also causally linked to the Covid shots.)
- Natural immunity
- High number of deaths and serious adverse reactions in VAERS
- VAERS estimated URF (under reporting factor) for an accurate estimate of risk
- Original Antigenic Sin and Disease Enhancement caused by vaccines
- Age-risk stratification
- Unknown long-term adverse effects with zero long-term safety data
- Ethics of experimental use authorization drugs for children by an outside expert in bioethics
- Risks of dosing by age not weight
- Zero carcinogenicity or reproductive toxicity studies
- Misleading mortality data on hospitalizations/deaths of children WITH Covid versus DUE TO Covid
- Cases do not equal hospitalizations; hospitalizations do not equal deaths
- Clinically misleading PCR tests
- Short-term waning immunity of Covid shots versus long-lasting natural immunity
- Proven alterations in innate immunity due to Covid shots
- Warning signals in recent data, unlike Pfizer’s data, shows that the covid vaccine may be causing, not preventing, premature deaths and illness. This mathematical evaluation of Covid vaccination efficacy in England concludes that infected vaccinated people are dying at a 14.5% percent higher rate than infected non-vaccinated people.
- Criminal history of Pfizer must be mentioned in every evaluation of a Pfizer product:
- Additionally, the presentations provide only the Relative Risk Reduction (RRR) from clinical trials, rather than the Absolute Risk Reduction (ARR). Absolute risk versus relative risk can be used disingenuously to manipulate public uptake of an experimental, for-profit drug.
“The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome reporting bias that affects the interpretation of vaccine efficacy . . .As was also noted in the BMJ Opinion, Pfizer/BioNTech and Moderna reported the relative risk reduction of their vaccines, but the manufacturers did not report a corresponding absolute risk reduction, which “appears to be less than 1%”.
- The presentations fail to include that the clinical trials in children were too small study and too short in duration to find serious adverse outcomes in either the short or long term. Pfizer’s report to the FDA for children ages 5-12, said: “The number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination.”
- One deceptive device used by Pfizer in their trials was the elimination of study subjects after the first shot if they experienced severe adverse reactions. Maddie de Garay was twelve when her mother enrolled her in Pfizer’s trial. She was injured by the first shot and is now paralyzed, but her injury is not listed in the clinical trial data.
- The shifting goalposts on transmission efficacy is misleading. ‘“Transmission efficacy” is the ability of a vaccine to prevent a new infection leading to disease. The focus of covid vaccine efficacy in children has shifted from prevention of death to prevention of hospitalization to to prevention of serious symptoms. In the lastest Pfizer trials, efficacy has shifted to using “antibody production” (ideally neutralizing antibodies, but not always.) Meanwhile, the unaware public is reading “efficacy” or “effectiveness” as all the same, which they are not. Efficacy is a measure of a vaccine in the ideal, controlled conditions of a drug trial, which can look quite high. High efficacy in a vaccine trial often does not translate to real-world effectiveness or safety.
In summary, the TAG presentation on criteria #6 shows a substantial lack of evidenceto support a “Yes” vote and overwhelming evidence to support a “No” vote. The presentation included NO data for transmission among school-age children and those in daycare according to their vaccine status, yet expected the members to vote on this without any evidence presented. Twelve out of seventeen members voted yes, despite NO evidence! The TAG team’s 12 of 17 “yes” majority vote in the face of non-existent evidence is troublesome and merits an independent investigation and a re-vote.