Evidence the FDA used for those decisions violates at least three safety and efficacy standards from earlier FDA publications
Evidence the FDA used for those decisions violates at least three safety and efficacy 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:
Amplifying those problems, the FDA approved the vaccines for young children even though the clinical trials:
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:
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:
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:
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:
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:
An FDA briefing document admits something even more revealing about the Moderna clinical trials on children of all ages:
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”:
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:
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:
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:
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:
In a study of 2,350 children aged 6–23 months conducted by Moderna:
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:
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:
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:
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:
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:
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:
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:
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:
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:
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:
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:
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:
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:
Produced in association with JustFacts
(Additional reporting provided by JustFacts)