Skip Navigation

FDA Violated Own Safety and Efficacy Standards in Approving Covid-19 Vaccines For Children

July 15, 2022

The FDA recently authorized Covid-19 vaccines for children as young as six months, despite the supporting evidence violating safety standards from earlier FDA publications.

The FDA recently authorized Pfizer’s and Moderna’s Covid-19 vaccines for children as young as six months. Troublingly, the evidence the FDA used for those decisions violates at least three safety and efficacy standards from earlier FDA publications about Covid-19 vaccines:

 

  • In 2021, the FDA warned that “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.” Yet, antibody tests are the main evidence the FDA cited when approving these vaccines for young children.

 

  • In 2021, the FDA declared, “We know from our vast experience with other pediatric vaccines that children are not small adults,” and thus, a “comprehensive evaluation of clinical trial data” is necessary to “support of the safety and effectiveness” of vaccines before they are “used in a younger pediatric population.” Yet, the FDA used small studies with narrow data and claimed these vaccines are effective and safe for children by extrapolating from studies done on adults.

 

  • In 2021, the FDA wrote that “the primary study objective” is that the vaccines are at least 30% effective with 95% confidence in preventing Covid-19. Yet, none of the studies on young children met this threshold, and some were negative, meaning that the vaccine could increase the chances of catching Covid-19.

 

Amplifying those problems, the FDA approved the vaccines for young children even though the clinical trials:

 

  • used antibody tests that are not targeted to the Omicron variant, which accounts for 100% of current Covid-19 cases.
  • excluded children apt to have serious adverse reactions to the vaccines.
  • found adverse reactions to the vaccines, including fevers up to 105.4 ºF, eye-rolling seizures, convulsions, limping, and a “severe” decline in white blood cells that creates the “risk of overwhelming infection.”
  • did not enroll enough children to show any clinically meaningful benefits like preventing severe Covid-19, hospitalization, or death.
  • would need to be 400,000 times larger/longer to determine if the vaccines save more toddlers and preschoolers than they kill.
  • fail to report the absolute efficacy rates of the vaccines, which a medical journal explains can “mislead and distort the public’s interpretation of Covid-19 mRNA vaccine efficacy and violate the ethical and legal obligations of informed consent.”
  • largely excluded children with evidence of a prior Covid infection, which exaggerates the efficacy of the vaccines and may downplay their risks.
  • had 1–3 months of blinded follow up for safety and efficacy, while the FDA and other health agencies said that one year should be the bare minimum.

 

The bulk of these facts come directly from the FDA, often buried on webpages in long lists of documents with vague recurring names like “Decision Memorandum.”

 

For thorough documentation of all these facts, including extensive quotes of the FDA documents with hyperlinks to them, continue reading. Or to jump to specific topics of interest, click on:

 

 

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.

 

More importantly, a 2012 paper in the journal Statistics in Medicine documents why using measures like antibody tests for clinical trial outcomes can be extremely dangerous:

 

  • “One of the most important considerations in designing clinical trials is the choice of outcome measures.”

 

  • Such measures “should provide reliable evidence about whether the intervention provides clinically meaningful benefit.”

 

  • A “true clinical efficacy measure”—like “death,” “pain,” “hospitalization,” “heart failure,” or “stroke”—“measures directly how a patient feels, functions or survives.”

 

  • “Indirect measures” like “antibody levels,” “fevers,” and “blood tests” are called “biomarkers.”

 

  • Biomarkers are often used as “surrogates” for clinically meaningful measures because they enable “clinical trials for regulatory approval to be smaller in size and shorter in duration.” The tradeoffs for those savings in cost and time are that biomarkers:
    • are “problematic” because they only provide “indirect” evidence of people’s health outcomes.
    • often fail to measure “important” side effects, and hence, “there are numerous examples where biomarkers have failed” to “provide reliable evidence about the benefit-to-risk profile” of treatments.
    • misled researchers to believe that one pertussis vaccine was better than another when the opposite was true.
    • misled doctors to prescribe “a quarter million U.S. patients annually” two heart medications that “actually tripled the death rate.”
    • misled researchers to conduct a clinical trial which had “unfavorable effects on overall survival” and was “terminated early.”
    • misled researchers to conduct another clinical trial which “resulted in a net 30% increase in the rate of death” or heart attacks.
    • don’t necessarily provide reliable evidence of efficacy even if they are “correlated with clinical efficacy measures.”
    • lead to “having less reliable insights about risks of rare but clinically important safety events or about longer term safety and efficacy….”

 

Underscoring the importance of the facts above, the authors explain that medical treatments “receiving regulatory approval” based on indirect measures like biomarkers are “more vulnerable to having clinically unacceptable safety issues discovered during the post-marketing period.”

 

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.

 

“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.

 

“Non-Related” Events

 

The cases above only include those that are “related” or “possibly related” to the vaccines in the judgment of the drug manufacturers and FDA. Some allegedly “non-related” events follow.

 

In a study of about 2,400 children aged 5 to 11 years, a child with “no reported medical history” of any conditions experienced these issues after the first dose of the Pfizer vaccine and did not take the second:

 

  • “mild headache with onset at 10 days after Dose 1 and resolved in 2 days.”
  • “mild joint swelling of the right ankle with onset at 16 days after Dose 1 and resolved in 3 days.”
  • “mild Henoch-Schoenlein purpura with onset of 21 days after Dose 1 and reported as ongoing at the time of the data cutoff date.” Per the Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, this disease involves blood escaping into “tissues, under the skin, and through the mucous membranes,” and it “may be associated with exposure to drugs or other chemical agents, systemic diseases such as multiple myeloma and leukemia, diseases affecting the bone marrow or spleen, and infectious diseases such as rubella (German measles).”

 

In a study of 2,350 children aged 6–23 months conducted by Moderna:

 

  • 9 children who received the vaccine experienced “serious adverse events” within 28 days of any injection,” 5 of which were hospitalized.
  • Moderna and the FDA decided that 8 of these cases were “unrelated” to the vaccine.
  • no child who received the placebo had a serious adverse event or was hospitalized, although this group was one-third the size of the vaccine group.
  • 5 of the 8 “unrelated” events involved diseases related to the immune system, including infections/conditions from adenovirus, rhinovirus, RSV, bronchiolitis, and PFAPA.

 

Given the small size of the study, Moderna correctly notes that “these imbalances” between the vaccinated and placebo groups may have “occurred by chance.” On the other hand, they may have occurred or been exacerbated because the mRNA vaccine compromised their immune systems, an effect reported by a 2022 paper in the journal Food and Chemical Toxicology. Without a clinical trial with many more children than this study involved, there is no way to be certain.

 

“Non-Serious” Events

 

Another area of uncertainty in the Covid vaccine trials is whether adverse events are “serious” or not. This involves the FDA and vaccine manufacturers making subjective and arguable judgments like the following.

 

A 2021 Pfizer briefing document for the FDA claims that all “serious adverse events” which occurred in a study of about 4,500 children aged 5 to 11 were “not related” to the vaccine. On the very same page, however, the document reveals a supposedly non-serious event “related” to the vaccine which led a participant to withdraw from the study after the first dose. This occurred because the child experienced:

 

  • a “severe” fever that peaked at 104.2 ºF (1 °C) on the third day after the vaccine and subsided a day later.
  • a “severe” decline in a type of white blood cells produced in bone marrow that are crucial to stopping bacterial infections. The girl had a “benign” history of this condition, but her levels dropped from 480/mm3 before the vaccine to 20 on the second day after the vaccine and then “improved to 70” by 23 days after the vaccine. Per the Gale Encyclopedia of Medicine, when levels of these cells decline below 200, “there is a “risk of overwhelming infection” which “requires hospital treatment with antibiotics.”

 

In a study of children aged 2–4 years, the FDA characterized a fever of 105.4 ºF (40.8 °C) as “non-serious.” The fever, which the FDA decided was “related” to the Pfizer vaccine, began 2 days after the first dose, lasted for 5 days, and led to the child’s withdrawal from the study.

 

In other cases involving children aged 6 months to 4 years, 5 of them withdrew from Pfizer studies after the first dose because of events that the FDA deemed to be “non-serious,” including 4 “related” to the vaccine.

 

Given that severe reactions to Covid vaccines tend to worsen with each dose, the withdrawal of these children from the study could mask more serious problems that might have occurred if they took the later doses. This applies to parents who follow the CDC’s advice and give their toddlers and preschoolers multiple doses of the vaccine, even if their child has a “non-serious” event on the first dose.

 

The risks from multiple doses are amplified for mRNA Covid vaccines because they linger in the body, effectively creating a higher dose with each injection. A key principle of toxicology is that all substances become toxic at high doses. The CDC claims without evidence that “our cells break down mRNA from these vaccines and get rid of it within a few days after vaccination,” but this is belied by a study published by the journal Cell in January 2022, which:

 

detected vaccine mRNA collected in the GCs [germinal centers] of LNs [lymph nodes] on days 7, 16, and 37 postvaccination, with lower but still appreciable specific signal at day 60.

 

The study did not look beyond 60 days, so the mRNA may remain longer.

 

30% Effective with 95% Confidence

 

In 2021, the FDA published a document recommending approval of the Pfizer Covid vaccine for everyone over the age of 15. It declared that “the primary study objective” is that the vaccines are at least 30% effective with 95% confidence in preventing Covid-19. Yet, none of the studies on young children meet this threshold, and some are far below it.

 

Clinical trials commonly report a confidence interval of 95% to determine if a study’s results are merely by chance. For example, if a study found with 95% confidence that a vaccine was 30–80% effective in preventing Covid, this would mean there is a low (5%) chance that the actual efficacy is outside of that range due to mathematical chance.

 

Accounting for such margins of error is especially important in studies with small numbers of participants and rare outcomes, like the Covid vaccine trials on young children.

 

The clinical trials used by the FDA had the following 95% confidence intervals, none of which reported a lower bound of 30% efficacy in preventing Covid, which the FDA previously required:

 

  • Moderna, ages 6–23 months: 21% to 69%
  • Moderna, ages 2–5 years: 12% to 54%
  • Pfizer, ages 6–23 months: –369% to 100%
  • Pfizer, ages 2–5 years: –8% to 98%

 

Negative numbers indicate that the vaccine may actually increase the chances of getting Covid. Some of these margins are outlandishly large because the studies were underpowered to measure Covid cases and because the FDA and vaccine manufacturers computed these results by excluding earlier parts of the studies.

 

For example, the results for children ages 6–23 months over the full span of Pfizer trial are actually –21% to 38%. This range confines the vaccine efficacy to no more than 38% and is far more narrow than the commonly reported one of –369% to 100%. That enormous span comes from only counting Covid cases that occur more than 6 days after the third dose of the vaccine.

 

Such incomplete measures—touted by Pfizer, Moderna, and the FDA—fail to convey the true efficacy of vaccination. This is because it doesn’t matter when a child gets Covid, but if a child gets Covid. As explained in the journal Therapeutic Innovation & Regulatory Science (and numerous other medical publications), “The first step in evaluating a therapy must be an unbiased intent-to-treat analysis. This is the only sure way to protect against potential bias.”

 

Media outlets often take the deception a step further by only reporting point estimates and failing to mention the margins of error. For example, a June 2022 article in the New York Times by Sharon LaFraniere reports the results of the studies above like this:

 

Moderna’s vaccine was 51 percent effective in preventing symptomatic infection in children 6 months to 2 years old and 37 percent effective in children 2 to 5 years old. Pfizer said its clinical trial suggested that its vaccine was 80 percent effective, but the trial was based on 10 cases. More than twice that number is required to assess the efficacy of the shots.

 

Those 10 cases are the result of combining the two trials of children aged 6–23 months and 2–5 years. Highlighting the weakness of the data, only 3 children in the younger group got Covid-19, including 2 who received the placebo and 1 who received the vaccine.

 

In the same age group over the full span of the Pfizer trial, 58 children who received the placebo and 98 who received the vaccine got Covid-19, although the vaccine group was twice as large. Again, this means the vaccine was –21% to 38% effective in preventing Covid, with a point estimate of 14%.

 

Absolute Efficacy

 

Worse still, all of the above efficacy measures are relative, not absolute. In Pfizer’s trial of children aged 6–23 months, 58 of 598 children who received the placebo got Covid-19, a rate of 9.7%. In contrast, 98 of the 1,178 children who received the vaccine got Covid-19, a rate of 8.3%. The difference between 9.7% and 8.3% is only 1.4 percentage points. This means the vaccine reduces the absolute risk of getting Covid by 1.4%, with wide margins of error.

 

Moderna, Pfizer, and the FDA routinely use absolute rates to convey the risks of harm from the vaccines, but when it comes to their benefits, they almost always mention relative rates.

 

A failure to report absolute efficacy rates was the subject of a 2021 paper in the journal Medicina. Singling out the Pfizer and Moderna Covid vaccine trials, Ronald B. Brown of School of Public Health and Health Systems at the University of Waterloo explains that:

 

absolute risk reduction measures are very much lower than the reported relative risk reduction measures. Yet, the manufacturers failed to report absolute risk reduction measures in publicly released documents. As well, the U.S. FDA Advisory Committee did not follow FDA published guidelines for communicating risks and benefits to the public, and the committee failed to report absolute risk reduction measures in authorizing the [Pfizer] and [Moderna] vaccines for emergency use. Such examples of outcome reporting bias mislead and distort the public’s interpretation of Covid-19 mRNA vaccine efficacy and violate the ethical and legal obligations of informed consent.

 

On top of all of this, symptomatic Covid is not a clinically meaningful outcome like hospitalization or death. Yet, these trials found little-to-no efficacy in this hollow measure.

 

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.

 

 

  • 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:
    • 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.
    • 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.

 

Short Follow Ups

 

The Covid vaccine trials on children are also deeply flawed because they were conducted for only several months, providing no evidence of their long-term efficacy and safety.

 

In November 2020, the ICMRA—a global association of healthcare regulatory agencies including the FDA and its counterparts in 33 other nations—issued a formal statement declaring that the clinical trials for Covid vaccines “should proceed as initially planned with a follow-up of at least one year or more from completion of assigned doses.” Emphasizing why this should be done, the ICMRA stated:

 

  • “To determine that the benefit of a vaccine outweighs its potential risk, regulators need robust and convincing evidence of the safety and efficacy that is obtained from well-designed randomised and controlled trials.”

 

  • “Thus, continued evaluation of the vaccinated and the unvaccinated” participants “for as long as feasible will provide invaluable information.”

 

  • Such information includes but is not limited to “additional and more precise information on longer-term safety,” “potential risks of vaccine-induced enhanced disease,” and “whether protection against Covid-19 disease wanes over time.”

 

  • “Therefore, unless maintaining participants in their randomised treatment groups (vaccinated or control) after a vaccine is approved is clearly infeasible, we recommend that clinical trials should proceed as initially planned with a follow-up of at least one year or more from completion of assigned doses.”

 

The statements above refer to a specific type of study called a placebo-blinded randomized controlled trial (RCT), the standard design for clinical trials. Done properly, such studies ensure that any significant difference in the outcomes of people who receive and don’t receive a treatment is, in fact, caused by the treatment and not some other factor. In the words of a clinical research methods guide, RCTs are the “gold standard” for clinical research because they provide “a rigorous tool to examine cause–effect,” which “is not possible with any other study design.”

 

Nevertheless, vaccine manufactures directly flouted the ICMRA’s guidance in its studies for adults. Instead of “at least one year or more,” Moderna conducted its main trial for a median of four months, and Pfizer ran it for an average of 3.3 months. This led the journal BMJ Evidence-Based Medicine to report in August 2021 that:

 

placebo controlled follow-up, originally planned for 2 years in many trials, was eliminated after a few months, when manufacturers began offering vaccine to placebo recipients within weeks of receiving emergency use authorisations.

 

The blinded follow up periods used by the FDA to approve the vaccines for young children have been even shorter, none more than 3 months:

 

  • In the Moderna trials for children aged 6 months to 5 years:
    • “The median duration of blinded follow-up for safety was 71 days after Dose 2 for participants 2 through 5 years and 68 days after Dose 2 for participants 6 through 23 months of age.”
    • “The median length of follow-up for efficacy post-Dose 2 was 71 days for participants 2 through 5 years of age and 68 days for participants 6 through 23 months of age.”

 

  • In the Moderna trials for children aged 6–11 years, the median length of blinded follow-up for safety was “51 days after the second dose.”

 

  • In the Moderna trials for children aged 12–17 years, the median length of blinded follow-up for:
    • safety was “53 days after the second dose.”
    • efficacy was “was 53 days post Dose 2.”

 

  • In the Pfizer trials for children aged 6–23 months, the median length of blinded follow-up after the third dose for:
    • safety was “1.3 months (range: 0–3.2 months).”
    • efficacy was “35 days.”

 

  • In the Pfizer trials for children aged 2–4 years, the median length of blinded follow-up after the third dose for:
    • safety was “1.4 months (range: 1–3.2 months).”
    • efficacy was “40 days.”

 

  • In the Pfizer trials for children aged 5–11 years, the median length of blinded follow-up after the second dose for safety was “at least 2 months” for the original subjects and “2.4 weeks” for a safety expansion group.

 

  • In the Pfizer trials for children aged 12–15 years, the median length of blinded follow-up after the third dose for safety was “≥2 months.”

 

Another fallout of those short follow ups is that some of the trials were run in the pre-Omicron era. For example, the FDA states that Moderna’s trial for children aged 6–11 years “include limited follow-up time during a period when Delta” was the most common variant. For ages 12–17 years, Alpha was the most common variant. However, the trials on children aged 2–5 years and 6–23 months overlapped with the “surge of the Omicron variant in the U.S.”

 

Even the trials conducted in the Omicron era could be rendered useless by their short follow ups because observational studies on adults suggest that the current mRNA vaccines only protect against becoming infected with Omicron for a month or two. A nationwide study conducted in Denmark and reported in a December 2021 working paper found that:

 

  • two doses of the Pfizer vaccine reduced the odds of becoming infected with Omicron by 24–74% among people who received the second dose in the previous month.
  • this protection “declines rapidly” so that people who received the second dose only two months prior had no statistically significant protection.
  • a third booster dose reduced the odds of becoming infected with Omicron by 30–70% for people who received the third dose in the previous 14 to 44 days.
  • the Moderna vaccine had roughly the same numbers with higher margins of uncertainty due to smaller samples.

 

Based on those results, the authors declare, “In light of the exponential rise in Omicron cases, these findings highlight the need for massive rollout of vaccinations and booster vaccinations.” Hidden beneath that conclusion and never mentioned in the text of the paper is a chart and table showing that unvaccinated people were:

 

  • 20–62% less likely to become infected with Omicron than those who received the second dose of the Moderna vaccine 4 to 5 months prior.
  • 60–95% less likely to become infected with Omicron than those who received the second dose of the Pfizer vaccine 4 to 5 months prior.

 

Even before Omicron, decisions to hastily end the RCTs were ill-advised because studies showed that the immunity conferred by the current C-19 vaccines wanes quickly in adults, such as:

 

 

Since all of those are observational studies, they don’t have the surety of RCTs and are therefore tentative. This is precisely why Dr. Doran Fink, Deputy Director of the FDA’s Division of Vaccines and Related Products Applications, warned at an FDA committee meeting in October 2020:

 

Once a decision is made to unblind an ongoing placebo-controlled trial, that decision cannot be walked back. And that controlled follow up is lost forever.

 

Summary

 

One day after the FDA announced that it had authorized the Moderna and Pfizer Covid vaccines for “children down to 6 months of age,” the CDC issued a press release recommending that “all children, including children who have already had Covid-19, should get vaccinated.” Along with this, the CDC and it’s director, Dr. Rochelle P. Walensky, declared:

 

  • “Covid-19 vaccines have undergone—and will continue to undergo—the most intensive safety monitoring in U.S. history.”
  • “Together, with science leading the charge, we have taken another important step forward in our nation’s fight against Covid-19.”

 

Quite unlike the CDC’s glowing press release, if government agencies were subject to the federal regulations which require pharmaceutical advertisements to include “important risks” and “disclosures” in a “balanced fashion,” the CDC could be forced to admit the following facts:

 

  • Antibody tests, which the FDA said “should not be used” to measure “protection from Covid-19 at any time,” are the primary evidence the vaccines protect against Covid.

 

  • The antibody tests, which were used to save time and money, are not targeted to the Omicron variant, which accounts for 100% of current Covid-19 cases.

 

  • Drugs that receive regulatory approval based on indirect measures like antibody tests are “more vulnerable to having clinically unacceptable safety issues” and misled doctors to prescribe millions of people heart medications that “actually tripled the death rate.”

 

  • The vaccines can cause fevers up to 105.4 ºF, eye-rolling seizures, convulsions, limping, and a “severe” decline in white blood cells that creates the “risk of overwhelming infection.”

 

  • The studies excluded children apt to have serious adverse reactions to the vaccines, and at least 6 children were withdrawn from the studies due to adverse events after the first dose.

 

  • Adverse effects in vaccinated subjects that the FDA considers “unrelated” to the vaccines include unexplained internal bleeding and diseases related to the immune system, which the vaccines may compromise.

 

  • The mRNA from the vaccines lingers in your body, possibly increasing the risk of toxic effects with each dose.

 

  • Children aged 6–23 months who received the Moderna vaccine had 9 “unrelated” “serious adverse events” and 5 hospitalizations, and none of the children who received the placebo had any, although this group was one-third the size of the vaccine group.

 

  • The trials did not enroll enough children to show any clinically meaningful benefits like preventing severe Covid-19, hospitalization, or death.

 

  • The efficacy and safety of the vaccines is largely inferred from studies on adults, even though the FDA warned that “children are not small adults.”

 

  • The studies conducted on toddlers and preschoolers would need to be 400,000 times larger/longer to determine if the vaccines save more children than they kill.

 

  • None of the studies found that the vaccines are at least 30% effective with 95% confidence in preventing Covid-19, a minimum standard that the FDA set in 2021.

 

  • For children aged 6–23 months, the Pfizer vaccine reduced the absolute risk of catching Covid-19 by 1.4%, not including the margins of error.

 

  • Children aged 6 months to 4 years who received the Pfizer vaccine had a higher rate of severe Covid-19 than those who received a placebo.

 

  • Prior Covid infection causes potent and durable immunity in the vast majority of people, but the studies largely excluded children with evidence of Covid infection and removed the few that remained from “key analysis sets.”

 

  • The clinical trials had 1–3 months of blinded follow up for safety and efficacy, even though the FDA and other health agencies said that one year should be the bare minimum.

 

  • Some of the studies were conducted before the emergence of the Omicron variant.

 

  • The vaccines may provide a few months of protection against contracting Omicron.
Article Tags
Health Care
Author
James D. Agresti is the president of Just Facts and a policy advisor to The Heartland Institute.
media@heartland.org

Related News & Opinion View All News