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Home My WebLink About8.22.22 Board Correspondence - FW_ Book (2)From:Paulsen, Shaina To:Pickett, Andy; Nuzum, Danielle Cc:Reaster, Kayla; Valencia, Shyanne Subject:Board Correspondence - FW: Book Date:Monday, August 22, 2022 8:08:10 AM Attachments:FDA-COVID19-Vaccines-Scientific-Fraud.pdf Shaina Paulsen Associate Clerk of The Board Butte County Administration 25 County Center Drive, Suite 200, Oroville, CA 95965 T: 530.552.3304 | F: 530.538.7120 From: lance dreiss <lancedreiss@att.net> Sent: Saturday, August 20, 2022 4:02 PM To: Stephens, Brad J. <BStephens@buttecounty.net>; Ritter, Tami <TRitter@buttecounty.net>; District Attorney <District_Attorney@buttecounty.net>; Waugh, Melanie <mwaugh@buttecounty.net>; Kimmelshue, Tod <TKimmelshue@buttecounty.net>; Connelly, Bill <BConnelly@buttecounty.net>; Lucero, Debra <DLucero@buttecounty.net>; Teeter, Doug <DTeeter@buttecounty.net>; Clerk of the Board <clerkoftheboard@buttecounty.net> Subject: Book .ATTENTION: This message originated from outside Butte County. Please exercise judgment before opening attachments, clicking on links, or replying.. Board of Supervisors, Clerk of the Board, Public Record, DA Ramsey, Sheriff Honea, County Counsel: https://urldefense.com/v3/__https://www.jeremyrhammond.com/wp-content/uploads/2022/08/FDA-COVID19-Vaccines-Scientific-Fraud.pdf? utm_source=ActiveCampaign&utm_medium=email&utm_content=Thanks*for*subscribing*21&utm_campaign=01a*- *Thanks*for*subscribing*21&vgo_ee=SRi41sZ55D9IFrb7xg6mDQLPkW1efsNDmrdD24*2FSjmA*3D__;KyslKysrKyUlJQ!!KNMwiTCp4spf!BKT_Kw5wwcTUbjvZ6NNceoiCmR- 5DC8biTdkpiFc2mSeDK52zxdRhh7M2d36ZMqMvRH2uOhl2k1oJBeUufi5iXMVW3x8Dw$ Thanks, diana dreiss Sent from my iPad “Jeremy Hammond is a brilliant and accomplished journalist…. One of my favorite people… A source of reliable information…. I really rely on his judgment a lot on a lot of the issues that are very complex….” — ROBERT F. KENNEDY, Jr., attorney, environmental activist, chairman of Children’s Health Defense, and author of The Real Anthony Fauci “Jeremy Hammond is one of the few courageous journalists who swims against this current of unparalleled corruption.” — ROB SCHNEIDER, actor and comedian “You can count on Jeremy R. Hammond for accurate analyses.” — DR. JAMES LYONS-WEILER, research scientist, founder and CEO of the Institute for Pure and Applied Knowledge (IPAK), and author of The Environmental and Genetic Causes of Autism “a writer of rare skill” — GENE EPSTEIN, former Economics & Books Editor at Barron’s and Director of The Soho Forum “incredible work” — Jefferey Jaxen, reporter for The Highwire “One of the best investigative journalists I’ve ever read.” — PETER R. QUINONES, host of The Pete Quinones Show “well worth reading” — DR. JOSEPH MERCOLA, founder of the leading natural health website Mercola.com How the US Government Puts Children’s Health at Risk in Service to the Pharmaceutical Industry Jeremy R. Hammond Version 1.1 © 2022 by Jeremy R. Hammond All Rights Reserved Cover background image: US Department of Defense photo by Lisa Ferdinando, licensed under CC BY 2.0. Cropped and blurred from the original. Introduction ...................................................................................... 1 Examples of the FDA’s Intent to Mislead ..................................... 4 The US Government’s Faith-Based Vaccine Policies ................... 8 The FDA’s Deceptive Exaggeration of the Risks to Children from COVID-19 ............................................................................. 15 Ignoring Natural Immunity and the Very Low Risk of Death in Children ................................................................................... 16 Deceiving about the Risk of Child Hospitalization ................ 20 Deceiving about the Risk of “Long COVID” in Children ... 25 Deceiving about the Risk of Myocarditis ................................ 30 Deceiving about the Risk of MIS-C from COVID-19 .......... 33 The FDA’s “Immunobridging” Fraud .......................................... 38 Falsely Equating Antibodies with Immunity ........................... 39 Ignoring Waning Immunity ....................................................... 42 Measuring Antibodies Against an Extinct Viral Strain .......... 46 The Politically Predetermined Outcome of the FDA’s “Analysis” ..................................................................................... 49 The Absence of Evidence for Vaccine Efficacy ........................ 51 Ignoring a Higher Rate of Severe COVID-19 and Repeated Disease Among Vaccinated Children ....................................... 53 Ignoring Negative Vaccine Effectiveness in Children ............ 56 Ignoring the Problem of “Original Antigenic Sin” with COVID-19 Vaccines ................................................................... 68 Ignoring Possible “Non-Specific Effects” of COVID-19 Vaccines ........................................................................................... 80 Ensuring that COVID-19 Vaccines Will Never Be Properly Assessed for Safety and Effectiveness ......................................... 84 Ensuring that Omicron-Based Booster Shots Won’t Be Tested in Clinical Trials .............................................................................. 86 Government Vaccine Policy Versus Science ............................... 91 Conclusion ..................................................................................... 101 Notes .............................................................................................. 104 1 n June 17, 2022, the US Food and Drug Administration (FDA) updated its emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include use in children aged six months to four years. In its press release announcing this decision, the FDA declared that “the known and potential benefits” of the vaccine for this age group “outweigh the known and potential risks”. The risk-benefit analysis upon which this conclusion was based, the FDA assured, was “rigorous and comprehensive”. FDA Commissioner Dr. Robert M. Califf announced that par- ents “can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thor- ough in its evaluation of the data.” The Director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, claimed that the agency’s analysis was “rigorous and thorough” as well as “transparent”. While “transparent” is arguably an apt description, the charac- terization of the FDA’s analysis as “rigorous”, “comprehensive”, and “thorough” is a demonstrable lie. Indeed, the FDA’s basis for authorizing the vaccine for infants and toddlers is transparently fraud- ulent. It should come as no surprise that the FDA would perpetrate scientific fraud in furtherance of the government’s policy goal of pushing COVID-19 vaccines on the population, but what is aston- ishing is just how brazenly the FDA did so in this case. O Introduction 2 The press release announcing the FDA’s decision contains a clue as to the lack of rigor and thoroughness in its risk-benefit analysis: Dr. Califf is further quoted as saying that FDA officials “expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death.”1 (Emphasis added.) The astute news consumer could thus come away with the un- derstanding that the FDA based its decision on an absence of data demonstrating that the vaccine is effective for preventing severe disease and death from COVID-19 in very young children. Instead, the FDA’s decision was based on expectation. To test that hypothesis, the US government decided to authorize and recommend the vaccine, lying to parents that clinical trials showed that it is “safe” and “effective”, and thus criminally treating the childhood population as subjects of a mass uncontrolled exper- iment without informed consent. The FDA’s decision was faith-based, not evidence-based. For the FDA to assure parents that the benefits of vaccination out- weigh the risks while at the same time acknowledging the absence of data demonstrating vaccine effectiveness illustrates the institution- alized cognitive dissonance surrounding the particular class of pharmaceutical products known as “vaccines”. The firm assurances in the FDA’s press release also contrast with the more equivocal and forthcoming language used in its authori- zation letter to Pfizer. The letter states that, based on the measure- ment of vaccine-induced antibodies, the FDA “concluded that it is reasonable to believe” that the vaccine “may be effective in individu- als 6 months through 4 years of age.” (Emphasis added.) Having presumed that the vaccine would be effective for prevent- ing COVID-19, the FDA leapt further to the conclusion that there- fore the benefits of vaccinating infants and toddlers would Introduction 3 outweigh the risks. The letter asserts that this conclusion is “based on the totality of the scientific evidence available”.2 But that is a lie. In truth, the FDA’s evaluation is very narrowly focused and riddled with factual and logical errors, and the FDA willfully ignored scientific evidence contradicting its claims and as- sumptions. The FDA’s conclusion that the risks to infants and toddlers will be outweighed by the benefits is premised on the unevidenced as- sumption that the vaccine will induce strong immunity. Hence, the agency’s conclusion is a logical fallacy. The FDA begged the ques- tion, presuming the proposition to be proven as its premise for au- thorizing the product for such very young children.3 Far from demonstrating rigor, comprehensiveness, and thor- oughness, a critical examination of the “Decision Memorandum” detailing the FDA’s ostensible risk-benefit analysis reveals how the US government engages in systematic scientific fraud that serves the financial interests of the pharmaceutical industry while putting children’s health and lives at risk. 4 he FDA’s decision memorandum includes numerous illus- trations of intent to mislead the public. For example, the memo declares matter-of-factly that SARS-CoV-2, the virus that causes COVID-19, is “a zoonotic coro- navirus”, meaning that it evolved in nature and leaped from a bat host reservoir population to humans, possibly with another animal species serving as an intermediary for the leap.4 In fact, a zoonotic origin of SARS-CoV-2 has not been proven, and the available evidence arguably favors the hypothesis that the virus is a product of laboratory “gain of function” research. Instructively, the FDA’s false claim that the virus is known to have evolved in nature serves to conceal the fact that the US gov- ernment funded research involving the controversial genetic engi- neering of coronaviruses by scientists from the Wuhan Institute of Virology in Wuhan, China, where the first outbreak of COVID-19 occurred.5 If the FDA were a trustworthy source of information, the memo would have honestly informed that the virus is of unknown origin. Instead, the FDA willfully lies, thus concealing the possible complicity of the US government in causing the COVID-19 pan- demic. This alone proves the FDA’s untrustworthiness. As another example, on the same page of the memo, the FDA states: T Examples of the FDA’s Intent to Mislead 5 Following EUA of the first COVID-19 vaccines in December 2020, COVID-19 cases and deaths in the US declined sharply during the first half of 2021. The emergence of the Delta variant, variable implementa- tion of public health measures designed to control spread, and continued transmission among unvac- cinated individuals were major factors in the resur- gence of COVID-19 in the US, leading to the Delta variant-associated peak in September of 2021 and the more recent surges in cases attributed to the Omicron variant.6 The FDA thus deliberately misleads people to the conclusion that it was the rollout of the vaccines that caused the sharp decline in cases observed during the first half of 2021, and that it was t he failure of much of the population to comply with the recommen- dations of “public health” officials, including the recommendation to get fully vaccinated, that resulted in subsequent resurgences of cases. The reality is that the proclaimed benefits used to justify the au- thoritarian “lockdown” measures never manifested in the data, whereas these policies are acknowledged to have caused devastating harms. A discussion of the relevant data in that regard is well beyond the scope of this article, but, more directly to the point, the refer- enced drop in COVID-19 case numbers cannot possibly be at- tributed to the rollout of COVID-19 vaccines. In fact, the inability of vaccines to explain the fall in case num- bers at that time has been acknowledged by Dr. Anthony Fauci, Director of the National Institute for Allergy and Infectious Dis- eases (NIAID, which is one of the government agencies, Examples of the FDA’s Intent to Mislead 6 incidentally, that funded genetic experimentation on coronaviruses by researchers from the Wuhan lab).7 The fact that vaccination was not responsible for the falling case numbers is illustrated by the data: the trend of falling case numbers had already begun by mid-January 2021, less than a month after the vaccines first received FDA authorization, at a time when less than 1 percent of Americans had been fully vaccinated, according to Examples of the FDA’s Intent to Mislead 7 data from the US Centers for Disease Control and Prevention (CDC).8 The FDA’s blaming of “unvaccinated people” for “continued transmission” of SARS-CoV-2 also falsely implies that fully vac- cinated people did not contribute to the spread of the virus, when in fact policymakers’ initial assumption that two doses of an mRNA COVID-19 vaccine would provide durable protection against in- fection and transmission had already been falsified by the end of July 2021.9 8 he faith-based decision making of “public health” officials was admitted by CDC Director Rochelle Walensky during a public discussion at the Washington University School of Medicine. As an explanation for why the vaccines had proven far less effective than government officials originally claimed, Wa- lensky told her audience: So many of us wanted to be hopeful. So many of us wanted to say, “Okay, this is our ticket out [of the pan- demic], now we’re done.” Um, so I think we had per- haps too little caution and too much optimism for some good things that came our way. I really do. I think all of us wanted it to be done. Nobody said “waning” [of vaccine-induced immunity would occur] when [the public was told], you know, “Oh, this vac- cine’s gonna work!’ [laughing]. [Nobody said,] “Oh, well, maybe it won’t work, it’ll wear off!” Um, nobody said, “What if [with] the next variant, it doesn’t—it’s not as potent against the next variant.” Walensky’s admission that public health officials presumed that the vaccines would induce durable sterilizing immunity and com- municated that belief to the public as “the science” without ever even considering that waning immunity or immune escape by variants might be a problem is highly instructive. T The US Government’s Faith-Based Vaccine Policies 9 (It isn’t true, of course, that “nobody” was talking at the time about waning immunity or reduced effectiveness against variants; plenty of critics of public vaccine policy were talking about pre- cisely those problems right from the very start, just as many of us were pointing out how “public health” officials were willfully lying about the benefits of COVID-19 vaccines, such as the CDC’s bald- faced lie that natural immunity is inferior to the protection con- ferred by the vaccines.10) Walensky’s comments also further illustrate the institutionalized cognitive dissonance surrounding vaccines. Immediately after ac- knowledging that the vaccines were sold to the public with the false promise that two doses would induce durable protection against infection, rather than accepting responsibility on behalf of the gov- ernment for having lied to the public, she blamed the public for having believed the lies: And then maybe the other thing I’ll say is this area of gray. I have frequently said, um you know, we’re gonna lead with the science, science is gonna be the founda- tion of everything we do. That is entirely true. I think the public heard that as, “Science is foolproof; science is black and white; science is immediate and we get the answer, and then we, you know, make the decision based on the answer.” And the truth is science is gray, and science is not always immediate, and sometimes it takes months and years to actually find out the an- swer. You have to make decisions in a pandemic be- fore you have an answer.11 Of course, the problem was not that people misinterpreted the public messages they were receiving from “public health” officials The US Government’s Faith-Based Vaccine Policies 10 like Walensky, who certainly made no effort to express the “gray” truth with public statements such as this message on Twitter: The science is clear: If you are vaccinated against #COVID19, you are safe. The vaccines work. You can take off your mask & are not at risk of severe disease or hospitalization.12 People heard that “science is black and white” on the question of vaccine effectiveness because that is precisely what officials like Walensky repeatedly told them, such as when she told MSNBC’s Rachel Maddow in March 2021: The US Government’s Faith-Based Vaccine Policies 11 We can kind of almost see the end. We’re vaccinating so very fast, our data from the CDC today suggests, you know, that vaccinated people do not carry the vi- rus, don’t get sick, and that it’s not just in the clinical trials but it’s also in real world data. Indeed, Maddow used that statement from Walensky to com- municate to her audience that while there had previously been “a scientific gray area” about whether vaccinated people could still be- come infected and transmit the virus, it was now black and white. Amplifying the disinformation from the CDC Director, Maddow lied: A vaccinated person gets exposed to the virus. The virus does not infect them. The virus cannot then use that person to go anywhere else. It cannot use a vac- cinated person as a host to get more people. That means the vaccines will get us to the end of this. If we just go fast enough to get the whole population vaccinated.13 There were no articles from the mainstream media’s self-de- scribed “fact checkers” to correct that officially approved disinfor- mation and to prevent the lie from being widely propagated on so- cial media. The faith-based nature of public policymaking with respect to COVID-19 vaccines was also illustrated in testimony from Dr. Deborah Birx, the former White House Coronavirus Response Co- ordinator, before a House of Representatives oversight committee. On July 23, 2022, Ohio Representative Jim Jordan pressed Birx with the question, “When the government told us that the vaccinated couldn’t transmit it, was that a lie, or was that a guess?” The US Government’s Faith-Based Vaccine Policies 12 Of course, it was both, since to characterize a guess or a belief as a scientifically proven fact is still lying; but setting aside that prob- lem with the question, instructively, Birx made no attempt to deny the fact that government officials had repeatedly provided false in- formation to the public in order to manufacture consent for their policy goal of achieving a high vaccine uptake. Instead, she admitted that such declarations, cloaked under the false pretense of representing “the science”, were premised on faith, not scientific data. Birx candidly answered the question by confessing: I think it was hope that the vaccines would work in that way. . . . I think they were hoping, but you should know in those original phase three trials that were done in this country, that we only measured for symp- tomatic disease, so we weren’t proactively testing eve- rybody in those trials to see if they got infected with mild or asymptomatic disease, so people had to pre- sent [with symptoms] within the clinical trials. So, we never had the data that it was going to protect against asymptomatic infection.14 Birx appeared to be blaming other “public health” officials for the deceptive communication about the effectiveness of COVID-19 vaccines, saying that “they” were hoping that the prod- ucts would prevent infection and transmission. But Birx was among those who lied to the public by claiming that the vaccines would do so. For instance, in an interview in December 2020, despite know- ing that the clinical trials were not designed to determine vaccine effectiveness against infection and transmission, Birx publicly The US Government’s Faith-Based Vaccine Policies 13 proclaimed that if 70 percent to 80 percent of Americans got vac- cinated, the US could “truly achieve herd immunity”.15 A key architect of the disastrous lockdown policies, Birx told Americans that these authoritarian measures could only be ended by getting everyone vaccinated. Ending the lockdowns, she said, was “a matter of vaccine and vigilance”: We can do this for a matter of weeks while we get our population immunized. We don’t need to have parties this year. We can have parties in July, we can have par- ties in August. We can have a party next year at this time. We ae so close. We have this great beacon of hope but we need to get everybody to that place and to be vaccinated.16 Thus, the false claim that Birx implicitly communicated to Americans was that two doses of a COVID-19 vaccine would in- duce durable sterilizing immunity that would prevent people from getting infected and stop them from transmitting the virus to oth- ers. More recently, on July 22, 2022, Birx offered the startling admis- sion, “I knew these vaccines were not going to protect against in- fection.” She acknowledged that “we overplayed the vaccines” by originally claiming otherwise.17 It is instructive that Birx participated in the government’s de- ceptive public relations messaging that claimed that the vaccines were a “great beacon of hope” that would end the pandemic and allow lockdown measures to be lifted by inducing durable sterilizing immunity and thereby achieving herd immunity, even though, by her own admission, she knew that the claim that the vaccines would prevent infection and transmission was false. The US Government’s Faith-Based Vaccine Policies 14 This pattern of faith-based decision-making, rejection of science, and willful dishonesty is palpable in the FDA’s decision memoran- dum. 15 mergency Use Authorization” (EUA) is a designa- tion for FDA unapproved and unlicensed pharma- ceutical products that are considered investigational or experimental for the target population.18 To support its conclusion that the Pfizer vaccine will confer a benefit to infants and toddlers that outweighs the risk of harm from the vaccine, the FDA had to characterize the risk to children from SARS-CoV-2 infection as concerningly high—an “emer- gency” situation justifying unapproved and experimental vaccination of children prior to the completion of randomized, placebo-con- trolled trials and licensure of the vaccine for use in that age group. The FDA acknowledged that symptoms in children are “gener- ally milder” than in adults, that most children recover within a week or two, and that 15 percent to 50 percent of children who become infected with SARS-CoV-2 never even develop COVID-19. (Note that the name of the clinical disease, coronavirus disease 2019, or “COVID-19”, is not to be confused with the name of the virus, which is severe acute respiratory syndrome coronavirus 2, or “SARS-CoV-2”). The FDA emphasized, however, that hospitalizations and deaths in children “have occurred”, and “symptoms may continue for weeks to months” in “some children”. The emergency use “E The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 16 authorization rested on the premise that vaccinating children will prevent such outcomes. It is at this point in the document that the FDA misleadingly suggests that vaccination was responsible for the drop in cases ob- served in early 2021, and that it was the refusal of many people to get vaccinated that resulted in the subsequent surge of the Delta variant that peaked that September as well as “the more recent surges in cases attributed to the Omicron variant.”19 The FDA does not acknowledge in this section of the docu- ment that the COVID-19 vaccines had proven less effective against the Delta and Omicron variants and do not prevent infection and transmission of the virus. It is completely uncontroversial in the medical literature that the duration of sterilizing immunity following vaccination, meaning protection against infection due to antibodies capable of neutraliz- ing the virus before it enters and replicates inside of cells, wanes rapidly. Nevertheless, the FDA was content to imply falsely that vaccinated people did not contribute to the spread that resulted in the later epidemic waves. Consistently, the FDA exaggerated the risks to children from COVID-19 while assuming that vaccination will reduce that risk de- spite an absence of evidence that the vaccine will provide durable or even transient protection. Ignoring Natural Immunity and the Very Low Risk of Death in Children “According to death certificate data,” the FDA decision memo- randum states, “202 deaths have been attributed to COVID-19 among children 6 months to 4 years of age through May 11, 2022.”20 The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 17 Tellingly, however, nowhere does the FDA provide an estimate of the infection fatality rate in children. On that basis alone, given the critical importance of this statistic for parental decision-making, the FDA’s analysis can hardly be called “rigorous” and “compr e- hensive”. The FDA’s analysis is also misleading because it fails to clarify that the number of deaths it presents is not the number of children for whom the underlying cause of death was COVID-19. Rather, the CDC dataset cited by the FDA tallies cumulative deaths “involving” COVID-19. Just because someone dies after having tested positive for SARS-CoV-2 does not necessarily mean that COVID-19 is what caused their death. The dataset includes the total number of death certificates on which ICD-10 code U07.1 (COVID-19) appeared, regardless of whether it was listed on Part I of the death certificate, which is for reporting the chain of events directly leading to death, with the “underlying cause of death” that precipitated the chain of events listed on the bottom line, or Part II, which is for reporting any other conditions that may have contributed to the death. In other words, it is inaccurate to refer to this dataset as showing deaths caused by COVID-19. While inclusive of COVID-19 deaths, the dataset is not limited to only those deaths for which COVID-19 was listed as the underlying cause. Therefore, a more accurate de- scription for the cumulative totals would be “COVID-19-related deaths”. Stratifying the cumulative totals of COVID-19-related deaths by age, as of June 2, 2022, there have been 72 such deaths in chil- dren aged six to eleven months, 67 in children aged one year, 27 in children aged two, 24 in children aged three, and 25 in children aged four. That’s a cumulative total since the start of the pandemic of 215 COVID-19-related deaths. The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 18 Concurrently, there have been 12,346 deaths from all causes in children aged six months to four years, so only 1.7 percent of deaths in this age group since the start of the pandemic have been associated with a SARS-CoV-2 infection.21 The low number of COVID-19-related deaths in young chil- dren is not because most children have yet to experience infection with the coronavirus. On the contrary, CDC data also show that most children have already been infected and therefore acquired natural immunity. A seroprevalence study by CDC researchers using tests designed to detect antibodies to the nucleocapsid (N) protein of SARS-CoV-2 found that, as of February, “approximately 75% of children and adolescents had serologic evidence of previous infec- tion with SARS-CoV-2”.22 Importantly, that is likely an underestimate for two main rea- sons. The first is that anti-N antibodies do wane over time (which doesn’t mean loss of immunity), so a significant number of chil- dren who had already recovered from infection might have had un- detectable levels at the time of testing. The second reason is that many children had been vaccinated, and vaccinated people who experience a “breakthrough” infection have an impaired ability to generate antibodies to the nucleocapsid protein.23 Therefore, it is likely that a significant number of vac- cinated children experienced a breakthrough infection but tested negative for anti-N antibodies. This limitation is acknowledged by the CDC researchers, who noted that their estimate was likely conservative in part “because infections after vaccination might result in lower anti-N titers”.24 The findings of the CDC’s seroprevalence study indicate that most children aged six months to four years have already acquired natural immunity, and yet the FDA conducted its risk-benefit anal- ysis as though all children were immunologically naïve. The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 19 The FDA explicitly acknowledges this “limitation” of its analy- sis, noting that it did not assess the benefit of vaccination in “previ- ously infected” children.25 On that basis alone, too, the characterization of the FDA’s anal- ysis as “rigorous” and “comprehensive” is falsified, but this is just the start of the FDA’s scientifically fraudulent basis for authorizing the Pfizer-BioNTech vaccine for infants and toddlers. According to US census data, the population of children aged zero to four as of 2020 was 19,301,292.26 If over three-quarters of children have already been infected and have antibodies against SARS-CoV-2, that means approximately 14.5 million children al- ready have evidence of natural immunity. The number of COVID-19-related deaths among children in this age group (in- cluding infants under six months old) as of June 2 is 442.27 Therefore, the infection fatality rate for this age group is some- thing less than 0.003%, or less than one child death per 33,333 in- fections. A recent study by researchers from the UK Health Security Agency and Public Health England estimated the infection fatality rate for children and adolescents to be far lower than that. They noted that death due to COVID-19 in people under the age of twenty “is extremely rare, even among those with underlying con- ditions” that are a risk factor for severe disease. The authors defined a “COVID-19 death” as any death occur- ring within 100 days of a positive SARS-CoV-2 test for which the infection was identified as having caused or contributed to the death, excluding those for which there was “a clear alternative cause”. They took great care to exclude deaths for which SARS-CoV-2 infection was apparently not the cause, communi- cating as necessary with responsible clinicians in cases where there was ambiguity. The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 20 Importantly, the researchers noted that “death certificates con- tain very limited information to ascertain the contribution of SARS-CoV-2 to the death”, and some death registrations “docu- mented ‘SARS-CoV-2’ or ‘COVID-19’ to be contributory even when the cause of death was unrelated to any infection.” They concluded that “deaths within 30 days of infection and death registrations both substantially overestimate fatalities” in chil- dren and adolescents. (Emphasis added.) In total, they identified only 185 deaths among children and ad- olescents in England for which COVID-19 could be reasonably at- tributed as the underlying cause or a contributing factor. Given the estimated numbers of infections in this age group, they estimated the infection fatality rate to be 0.0007 percent.28 That’s one child death per 142,857 infections. To demonstrate a mortality benefit of vaccination, therefore, there would have to be hundreds of thousands of children in the clinical trial. Instead, as we will come to, the FDA based its assump- tion of a mortality benefit on a scientifically fraudulent “immuno- bridging” analysis plus efficacy data failing to show significant pro- tection against symptomatic infection. The trial was not designed to determine severe disease or mortality outcomes, and the FDA had efficacy data on just 4,526 children aged six months to four years old, among whom 3,013 were assigned to receive the vac- cine.29 Deceiving about the Risk of Child Hospitalization Common knowledge that the risk of children dying from COVID-19 is extraordinarily low poses a challenge to policymakers seeking to persuade parents to vaccinate their kids. Another com- plication for the FDA, given its evidently predetermined conclusion that the vaccine should receive emergency use authorization, is that The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 21 it is also common knowledge that the risk of severe COVID -19 is much higher for people with certain underlying medical conditions. The FDA nevertheless attempted to downplay the even lower risk to healthy children by claiming that “a majority of children hos- pitalized for COVID-19 have no underlying medical conditions.” Citing data from the CDC, the memo states, “Of children 6 months to 4 years of age with COVID-19 associated hospitaliza- tion, 49% had one or more underlying health conditions.”30 However, that is an untrue statement, for several reasons. First, the referenced dataset does not stratify hospitalizations by the age group of six months to four years. Rather, the age group includes children from birth to four years. Thus, the FDA is inclu- sively citing the hospitalization rate of infants who are too young to receive the vaccine and who disproportionately contribute to the overall hospitalization rate for this age group. In fact, for other purposes, the FDA cites a CDC study from August 2020 finding that “Infants aged <3 months accounted for 18.8% of all children hospitalized with COVID-19.”31 More re- cently, the CDC has published data indicating that, during Omicron predominance, “infants aged <6 months accounted for 44% of hospitalizations.”32 Second, the data are not limited to cases where children were hospitalized because of COVID-19. Rather, the numbers shown are for “COVID-19-associated hospitalizations”, which includes chil- dren who tested positive for SARS-CoV-2 and were hospitalized, but who were not necessarily hospitalized because of infection with SARS-CoV-2.33 The CDC defines “COVID-19-associated hospitalizations” as “receipt of a positive SARS-CoV-2 real-time reverse transcription- polymerase chain reaction [RT-PCR] or rapid antigen detection test result during hospitalization or during the 14 days preceding admis- sion.”34 The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 22 The CDC study finding that COVID-19-associated hospitaliza- tions among children were disproportionately infants under six months of age also states that the primary reason for admission was “likely COVID-19 related” in 84.8 percent of cases, thus ac- knowledging that at least 15 percent of children hospitalized had some other primary reason for being there.35 According to a commentary published in the journal Hospital Pediatrics, a publication of the American Academy of Pediatrics (AAP), it has been estimated that around 40 percent of “COVID-19-associated” hospitalizations represent children who were in the hospital and tested positive, but who were there for other reasons, with the COVID-19 diagnosis being incidental to the purpose of their visit.36 Third, the data cited, from the CDC’s “COVID-NET” network of hospitals, do not show that most children had no comorbidities. On the contrary, at the time of this writing, the downloadable spreadsheet providing data on underlying medical conditions of COVID-19-associated hospitalizations shows that only 45 percent of children aged zero to four years are listed under the category of “No known condition”. The rest had one or more other medical conditions, including obesity, neurologic disease, asthma, chronic lung disease, gastrointestinal or liver disease, cardiovascular disease, The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 23 metabolic disease, immune suppression, autoimmune disease, renal disease, or hypertension.37 Thus, the FDA falsely characterized the data as exclusive of in- fants under six months old who are disproportionately represented in the data, falsely characterized the data as including only of chil- dren who were hospitalized because of COVID-19, and falsely claimed that the data show that a majority of hospitalized children had no underlying conditions placing them at higher risk of severe disease. Once again, therefore, evidence that the FDA’s analysis is “rig- orous” and “thorough” is lacking. To be fair to the FDA, in this section of the memorandum, it also cites an early CDC study, published in August 2020, finding that 42.3 percent of children with COVID-19-associated hospitali- zation had an underlying medical condition, thus suggesting that most children did not. However, the underlying data for that study was also from COVID-NET and so must be reconciled with the up-to-date data indicating that more than half of children did have at least one other diagnosed medical condition at the time of hos- pitalization. It’s also worth pointing out that the data from that early CDC study showed that there were 576 children with COVID-19-associ- ated hospitalization during the study period out of a study popula- tion of 7,200,000, which equates to a rate of one hospitalization per 12,500 children, or 0.008%. Among those hospitalized, 69 were admitted to the ICU, giving a rate of one ICU admission per 104,347 children, or 0.0009%. There were nine children diagnosed with MIS-C, giving a rate of one case per 800,000 children, or 0.0001 percent. Finally, there was only one recorded death, giving a rate of one death per 7,200,000 children, or 0.00001 percent.38 Also, the more recent CDC study of childhood hospitalization during Omicron predominance, which the FDA did not cite, found that “63% of hospitalized infants and children had no underlying The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 24 medical conditions”. However, again, the data came from COVID-NET and so must be reconciled with the fact that the downloadable spreadsheet shows that fewer than half of children had no other diagnosed medical conditions. That figure is also confounded by the lower likelihood of infants being diagnosed with underlying medical conditions compared to older children. Whereas the rate of one or more underlying medical conditions was only 26.3 percent for infants under six months of age, it was 40.3 percent for children aged six to twenty-three months and 81.8 percent for children aged two to four years.39 Thus, the FDA’s implicit claim that COVID-NET data show that most hospitalized children aged two to four have no underlying medical conditions is false. The FDA’s attempt to downplay the lower risk to healthy chil- dren is also contrasted by the data in the UK study estimating the infection fatality rate in children to be 0.0007 percent. That study found that children with underlying comorbidities had a 2.5-fold increased risk of dying from COVID-19, with 75.3 percent of deaths occurring in children with an underlying condition, of which the leading two were “neurodisability” and “immunocompromising conditions”.40 As of June 18, the CDC’s data show that there has been a cu- mulative total of 4,006 COVID-19-associated hospitalizations among children aged zero to four years. Considering the population of children in this age group, that equates to a risk of COVID-19- associated hospitalization since the start of the pandemic of just 0.02 percent, or 1 in 5,000.41 In other words, despite most children already having experi- enced infection, over the whole course of the pandemic, again us- ing the census data from 2020, only a cumulative total of 1 in 5,000 children have been hospitalized while also having tested positive for SARS-CoV-2. The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 25 If 15 percent of those COVID-19 diagnoses were incidental to the purpose for the visit, the cumulative total would be one COVID-19 hospitalization per 5,882 children, or an absolute pan- demic-long risk of just 0.017 percent. If 40 percent of diagnoses were incidental, the cumulative total would be one in 8,333, or an absolute pandemic-long risk for COVID-19 hospitalization of just 0.012 percent. Of course, the risk of severe disease and death has only grown smaller over time as the proportion of immunologically naïve chil- dren has decreased and the virus has mutated to become less viru- lent, generally causing milder symptoms compared to earlier vari- ants. Finally, even if the information about the risk to children of hospitalization due to COVID-19 presented by the FDA were cor- rect, the FDA failed to produce any data to support its assumption that vaccination would reduce that risk among children six months to four years of age. The FDA’s decision was based on faith and hope, not scientific evidence. Deceiving about the Risk of “Long COVID” in Children Since it is widespread public knowledge that the risk of death to children from COVID-19 is statistically zero, as is the risk of hospitalization, the FDA highlighted the risk of long-term morbid- ity following SARS-CoV-2 infection, often referred to as “Long COVID”. The memo states, “Data on the prevalence of long COVID in children is sparse; however, a national survey in the United King- dom found that among children ages 2-11 years who tested positive for COVID-19, 7.2% reported continued symptoms at 12 weeks.”42 The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 26 The FDA thus infers that over 7 percent of children infected with the virus may develop Long COVID. However, the source cited, a report from the UK Office for Na- tional Statistics, explicitly states, “It is not possible to infer from this analysis whether self-reported symptoms are caused by coro- navirus infection.” The FDA declined to relay that caveat, which is yet further evidence of intent to mislead. While the UK study did compare the percentage of participants reporting any symptom after testing positive for SARS-CoV-2 with a control group “who were unlikely to have themselves been in- fected”, the methodological limitations of this survey and the risk of selection bias preclude drawing any firm conclusions about the relative risk of long-term systems among those who tested posi- tive.43 Estimates from such surveys or observational data of the pro- portion of people who develop persistent symptoms after SARS-CoV-2 infection are confounded by other causal or contrib- uting factors, including the negative health effects of lockdown measures and the trauma of simply testing positive in the context of persistent and intensive fearmongering about the risks from the virus emanating incessantly from the government and mainstream media over the course of the pandemic. As noted in an article published in JAMA in October 2020: In addition to symptom persistence and clinical se- quelae that may last far beyond the initial COVID-19 illness, the extent of emotional and behavioral con- cerns and general distress for those affected has yet to be determined. A diagnosis of COVID-19, and sub- sequent need for physical distancing, has been associ- ated with feelings of isolation and loneliness. COVID-19-related stigma has also become pervasive The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 27 and can result in a sense of hopelessness. Increasing reports of lingering malaise and exhaustion akin to chronic fatigue syndrome may leave patients with physical debility and emotional disturbance. Com- pounded by the psychological toll of the pandemic experienced population wide, individuals recovering from COVID-19 may be at even greater risk of de- pression, anxiety, posttraumatic stress disorder, and substance use disorder. These combined effects have the potential to result in a global health crisis, consid- ering the sheer number of COVID-19 cases world- wide.44 A study published in Acta Paediatrica in April 2021 aimed to as- sess the prevalence of persistent symptoms in children previously diagnosed with COVID-19 and found that 43 percent of children reported one or more symptoms more than 60 days after infection, including “fatigue, muscle and joint pain, headache, insomnia, res- piratory problems and palpitations”. The study lacked a control group, however, and the authors pointed out that further studies with control subjects would be required to separate the effects of prior infection from harmful health effects of the lockdowns and the general trauma that the population had been experiencing. There was “increasing evidence”, the authors noted, “that re- strictive measures aimed at limiting the pandemic are having a sig- nificant impact on child’s mental health. Childhood is a delicate and fundamental period of life, critical for acquisition of social, behav- ioral and educational development.”45 In May 2021, a study by a team of German researchers was pub- lished on the preprint server medRxiv titled “Mental health of Ad- olescents in the Pandemic: Long-COVID19 or Long-Pandemic Syndrome?” They compared reported symptoms among The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 28 adolescents who tested positive for antibodies to SARS-CoV-2 and adolescents who tested negative. They found “no statistical differ- ence comparing the reported symptoms between seropositive stu- dents and seronegative students.” As the authors concluded, this finding suggests that Long COVID “might be less common than previously thought” and highlights “the impact of pandemic-associated symptoms regard- ing the well-being and mental health of young adolescents.” (Of course, by “pandemic-associated”, they really meant “lockdown-as- sociated”; it has been a common convention for commentators to misattribute the harmful consequences of government policies to “the virus” or “the pandemic”.)46 Evidence of the prevalence of Long COVID was “predomi- nantly limited to select populations without control groups,” noted Swiss researchers in a letter published in JAMA in July 2021. In their own research, they found that 4 percent of children who tested positive for antibodies to SARS-CoV-2 reported at least one symptom lasting more than twelve weeks compared to 2 percent of children who tested negative. The proportions of children in each group reporting excellent or good health were similar, and the au- thors summarized their findings as indicating “a low prevalence of symptoms compatible with long COVID”.47 Despite finding a much higher rate of long-term symptoms, a similar conclusion was drawn by researchers in the UK in a preprint study published at Research Square in August 2021. They found that 67 percent of children and adolescents reported symptoms three months after having tested positive for SARS-CoV-2. However, this compared with 53 percent of children who reported similar symp- toms three months after having tested negative. Emphasizing the importance of including a negative control group in studies on prevalence of Long COVID, the authors re- marked, “it is unclear whether the features associated with Long The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 29 COVID are related to the viral infection or the effects of the pan- demic, lockdown and school closures with consequent social isola- tion.”48 A particularly illuminating study by researchers in France pub- lished in JAMA Internal Medicine in November 2021 found reported persistence of symptoms to be associated with the mere belief among subjects that they had previously been infected with SARS- CoV-2. The authors found persistent physical symptoms to be associ- ated with self-reported infection, but the only symptom that was associated with receipt of a confirmatory serological test was loss of taste or smell. As the authors concluded, their findings “suggest that persistent physical symptoms after COVID-19 infection may be associated more with the belief in having been infected with SARS-CoV-2 than with having laboratory-confirmed COVID-19 infection.” (Empha- sis added.) They therefore also emphasized the need for further research accounting for causal factors “that may not be specific to the SARS- CoV-2 virus” and cautioned that careful medical evaluation was re- quired to ensure that patients’ symptoms are not “erroneously at- tributed to ‘long COVID.’”49 Another study shedding much-needed light on the subject was published the same month in the Journal of Infection. Noting that there were conflicting data on the long-term impact of SARS-CoV-2 infection on children, the authors conducted a sys- tematic review and meta-analysis of the literature and found an as- sociation between higher quality of studies and lower prevalence of symptoms other than loss of smell and cognitive symptoms. Looking only at studies that included a control group, the re- searchers found that the frequency of most persistent symptoms reported by people after having tested positive for SARS -CoV-2 The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 30 was similar to that reported by people who tested negative. They, too, emphasized that their findings highlighted “the critical im- portance of a control group” in studies adequately designed to dis- tinguish symptoms attributable to SARS-CoV-2 infection from symptoms attributable to other causes.50 In sum, the FDA’s reliance on a single source, from which it is logically “not possible to infer” whether the self-reported symp- toms were caused by SARS-CoV-2 infection, to mislead people into the belief that more than 7 percent of children who test positive may develop Long COVID is just another illustration of how the agency serves the pharmaceutical industry through deliberately de- ceptive fearmongering. Furthermore, even if we were to assume for the sake of argu- ment that over 7 percent of children develop Long COVID, the FDA failed to produce any data to support its assumption that vac- cination would reduce that risk. The FDA acknowledges this failure, noting understatedly in its “limitations” section that “available data are not conclusive on the effectiveness of COVID-19 vaccines currently in use against long- term sequelae of COVID-19 among individuals who are infected despite vaccination. Additional evaluation is needed to assess the effect of this vaccine in preventing long-term effects of COVID-19, including data from clinical trials and from the vac- cine’s use post-authorization.”51 Deceiving about the Risk of Myocarditis Yet another fact widely known among the public that poses a challenge to the policy goal of getting the entire population vac- cinated is that COVID-19 vaccines have been associated with an increased risk of myocarditis, or inflammation of the heart. The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 31 To overcome that obstacle, the FDA similarly misleads about the risk to young children of experiencing myocarditis due to COVID-19. The decision memorandum states: Following observation of an increased incidence of myocarditis in 2020 compared to 2019, several studies have suggested an association between COVID-19 and myocarditis. While the overall incidence of myo- carditis following COVID-19 is low, persons with COVID-19 have a nearly 16-fold increase in risk for myocarditis, compared to individuals without COVID-19.52 To support this claim, the FDA cites a study whose authors noted that while persons with COVID-19 were found to have an 8-fold increased risk for myocarditis, there remained a low absolute risk of 0.1 percent. The authors of that study, published in CMAJ in January 2021, emphasized the importance of also presenting absolute risk esti- mates and not only relative risk by stating: This study provides estimates of absolute risk and rel- ative odds for all identified diagnoses related to COVID-19, which are needed to help providers, pa- tients and policymakers understand the likelihood of complications. For example, acute myocarditis was found to have an OR [odds ratio] of 8.17 but an over- all risk of 0.1%, illustrating how a very strong associ- ation of a condition with COVID-19 does not neces- sarily translate into a high overall risk.53 The FDA certainly understands how highly misleading it can be to present only an increased relative risk while willfully withholding The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 32 estimates of increased absolute risk. The FDA knows that this can cause people to perceive their risk as being orders of magnitude higher than it really is. This perfectly explains why the FDA chose to withhold the estimated absolute risk from its cited source. Here is what the FDA itself had to say about this type of mis- leading presentation of statistics in a guidance document on appro- priate risk communication from 2011 (emphasis added): Another statistical choice is between reporting relative or absolute risks. Because there is no way to infer the latter from the former, absolute risks are always more in- formative. Doubling a risk means very different things if that entails going from 10% to 20% or from 0.001% to 0.002%. Even when they contain the same information, different summaries can highlight differ- ent perspectives, hence bias choices. Although quantitative summaries can be problematic, they are essential for communicating how big risks (and benefits) are. Verbal expressions (e.g., rare, possible, large) are known to mean different things to different people and to the same people in different contexts.54 Now consider again how the FDA in its decision memorandum brushed aside the absolute risk as cryptically “low” while quantify- ing a sixteen times greater relative risk of myocarditis following COVID-19 diagnosis. Consider further how the FDA did so despite its own source emphasizing the need to quantify the absolute risk of myocarditis following COVID-19 in order not to mislead people by presenting only the relative risk. Again, the conclusion is inescapable that it is the FDA’s intent with this document to mislead the public. The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 33 As if that weren’t damning enough, also notice that the FDA claimed a “16-fold” increase in relative risk when its source actually presented an 8-fold increased risk. This falsehood could perhaps be generously attributable to human error rather than malicious intent, but it certainly weighs the evidence further away from the conclu- sion that the FDA’s analysis was “rigorous” and “thorough”. It’s also worth noting that a large study of Israeli adults pub- lished in the Journal of Clinical Medicine on April 15, 2022, found no increased risk of myocarditis associated with COVID-19 diagno- sis.55 Finally, even if the information presented in the decision mem- orandum were correct, the FDA failed to produce any data to sup- port its assumption that vaccination would reduce the risk of myo- carditis either in the short or long term among children six months to four years of age. The clinical trial was not large enough to detect any cases of myocarditis, much less to be able to meaningfully compare the rate of myocarditis over time between the vaccine and placebo control groups. As the FDA also points out in its limitations section, “The risk of vaccine-associated myocarditis/pericarditis among children 6 months through 4 years of age is unknown at this time.”56 Once again, the FDA’s conclusion that the benefits outweigh the risks is faith-based, not evidence-based. Deceiving about the Risk of MIS-C from COVID-19 The FDA similarly exaggerates the risk to children from SARS-CoV-2 by stating that multisystem inflammatory syndrome in children (MIS-C) “is a rare but serious COVID-19-associated condition that occurs in less than 1% of children with confirmed SARS-CoV-2 infection.”57 The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 34 The FDA thus implies that the incidence of MIS-C has been estimated as approaching one case for every 100 children infected with SARS-CoV-2. That is false. The source that the FDA cites to support that statement is as follows: Dufort EM et al. COVID-19: Multisystem inflamma- tory syndrome in children (MIS-C) clinical features, evaluation, and diagnosis. N Engl J Med. 2020;383(4):347.58 However, no such study exists. Evidently, the FDA sloppily con- flated two different studies, citing the authorship and publishing journal from one of the studies while misattributing the name of the published paper, which came from a study by different authors published in a different journal. The study named by the FDA was rather written by Mary Beth F Son et al. and published at UpToDate, an online resource for healthcare professionals. That article states: While the incidence of MIS-C is uncertain, it appears to be a relatively rare complication of COVID-19 in children, occurring in <1 percent of children with confirmed SARS-CoV-2 infection. In one report from New York State, the estimated incidence of la- boratory-confirmed SARS-CoV-2 infection in indi- viduals <21 years old was 322 per 100,000 and the incidence of MIS-C was 2 per 100,000.59 The referenced report from New York is the one by Dufort et al. published in the New England Journal of Medicine in July 2020, which was rather titled “Multisystem Inflammatory Syn- drome in Children in New York State”.60 The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 35 As indicated, that study estimated that COVID-19-related MIS-C had occurred in 0.002 percent of the population under the age of twenty-one. It did not estimate the rate at which MIS-C oc- curred among individuals infected with SARS-CoV-2. That is, it did not distinguish COVID-19-related MIS-C from the background in- cidence. The highly imprecise estimate of “<1 percent” was simply in- ferred based on the reported rate of infection in the same popula- tion from March 1 to May 10, 2020. If we unreasonably assume that all the reported cases of MIS-C were infection-related, we could infer a rate of 2 cases per 322 infections, or 0.62 percent. The FDA chose to cite this very early rough guess, deceptively implying that the rate of MIS-C following SARS-CoV-2 infection could be nearly 1 case per 100 infections, rather than citing a study actually designed to estimate the incidence of COVID-19-related MIS-C, even though another source cited by the FDA did provide an actual estimate, which the FDA chose not to disclose. Among the studies cited by the FDA in this section of the de- cision memorandum is one published in Clinical Infectious Diseases in December 2021. The authors of that study importantly concluded that, “Over the first 3 pandemic waves of MIS-C in the United States, cardiovascular complications and clinical outcomes includ- ing length of hospitalization, receipt of ECMO [extracorporeal membrane oxygenation], and death decreased over time.” In its decision memorandum, the FDA also chose not to relay this key conclusion that the severity of COVID-19-related MIS-C appeared to be decreasing over time. This finding is unsurprising both because the population of susceptible children without immunity to SARS-CoV-2 decreased over time and because the virus has mu- tated to generally cause less severe disease than the originally circu- lating strain. The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 36 The FDA also chose not to disclose the estimated rate of COVID-19-related MIS-C presented in that same study (emphasis added): The CDC established a national reporting platform to systematically collect data on suspected cases of MIS-C from health departments. MIS-C incidence in 7 jurisdictions from April to June 2020 was 1 case of MIS-C per approximately 3200 SARS-CoV-2 infections among persons aged <21 years.61 That estimate came from another study titled “Incidence of Multisystem Inflammatory Syndrome in Children Among US Per- sons Infected With SARS-CoV-2”, which was published in JAMA Network Open on June 10, 2021. Turning to that primary source, it noted that “The ability to es- timate MIS-C incidence relative to overall SARS-CoV-2 infections has been restricted by the limited ability to estimate the number of SARS-CoV-2 infections based on reported COVID-19 case counts.” This is because far more people had experienced infection with the coronavirus than had tested positive and been included in case counts. Using only reported cases in the denominator would overestimate the risk. So, using a multiplier to account for underre- porting of infections, the study estimated the incidence to be 316 cases of MIS-C per 1,000,000 SARS-CoV-2 infections, or a rate of 0.0316 percent.62 In short, the FDA had this estimated incidence of 1 case per 3,165 infections on hand, but it chose to withhold this data and instead deceive the public into believing that the rate is something approaching 1 case per 100 infections. Moreover, a study by researchers in Israel whose findings were reported in a letter to JAMA on May 19, 2022, confirmed the The FDA’s Deceptive Exaggeration of the Risks to Children from COVID 19 37 previous finding that severity as well as incidence of COVID-19-re- lated MIS-C had declined over time. The estimated incidence dur- ing the Alpha variant wave was 1 case per 1,833 infections. During the Delta wave, it was 1 case per 2,031 infections. During the Omi- cron, it wave was 1 case per 26,299 infections.63 That’s a risk of being diagnosed with MIS-C after experiencing a SARS-CoV-2 infection of 0.0038 percent. Obviously, to state that the rate is “less than 1%” is more ame- nable to the FDA’s transparently predetermined conclusion than to honestly disclose the estimated rate of “0.03%” from its own cited source or to have reported the estimate of “0.0038%” from the more recent Israeli study confirming a far lower risk of COVID-19- related MIS-C now that Omicron is the predominantly circulating variant. Once again, therefore, we see clear evidence of intent to mislead and to exaggerate the risks to children from COVID-19 in further- ance of the predetermined agenda to authorize the vaccine for chil- dren as young as six months. Additionally, the FDA presented no data to support its assumption that vaccination would reduce this risk to infants and toddlers. 38 he FDA’s authorization of Pfizer’s COVID-19 vaccine for children aged six months through four years was not based on demonstration of vaccine efficacy against infection, se- vere disease, hospitalization, or death. Instead, as stated in the decision memorandum, vaccine effec- tiveness “was inferred by immunobridging based on a comparison of immunogenicity endpoints” between the target age group and older children. (Emphasis added.) What the FDA did was to compare the antibody responses in infants and toddlers with those observed in adolescents and young adults. The data for this analysis came from lab measurements of antibody neutralization activity against the spike protein in blood samples from vaccinated children. Since the vaccine induced a sim- ilar level of neutralizing activity in both comparison groups, the FDA reasoned, therefore the vaccine will be effective in preventing COVID-19 in the younger age group.64 However, this reasoning is a non sequitur fallacy: the conclusion that the vaccine will induce effective immunity does not logically follow from the premise that younger children produce a similar level of neutralizing antibodies as older children. For the FDA to fallaciously leap to that conclusion and present it to the public as though the claimed benefit had been scientifically demonstrated is scientific fraud, and the FDA knows it. T The FDA’s ‘Immunobridging’ Fraud 39 Falsely Equating Antibodies with Immunity The FDA is perfectly aware that just because an individual pro- duces a high level of antibodies against SARS-CoV-2 does not nec- essarily mean that they are protected from the disease. Scientists have not yet established correlates of immunity for SARS-CoV-2, meaning that it remains unclear what specific im- mune responses equate to protection against COVID-19. There is no level of neutralizing antibodies to the spike protein that by itself serves as a measure of immune protection. Interestingly, the FDA has itself cautioned that detection of an- tibodies is insufficient evidence of immunity. On May 19, 2021, the FDA issued a statement instructing that “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.” That page of the FDA’s website presently shows as being current as of February 24, 2022.65 Another FDA webpage current as of the same date states: A positive SARS-CoV-2 antibody test does not neces- sarily mean you are immune or have immunity that will prevent COVID-19. More research is needed to understand what SARS-CoV-2 antibody test results can tell us. And, SARS-CoV-2 antibodies detected in your blood reflect only one part of your immune sys- tem, which also includes T-cells and other compo- nents that are part of your body’s immune response.66 The FDA further admits in its EUA decision memorandum that “no specific neutralizing antibody titer has been established to pre- dict protection against COVID-19”.67 Yet, the FDA used neutralizing titers as its basis for assuming protectiveness anyway. The FDA’s ‘Immunobridging’ Fraud 40 During a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28, voting member Dr. Ofer Levy asked a Pfizer representative what the cor- relate of protection is. “Everybody’s measuring antibodies,” he noted. “They’re probably relevant, but as we know . . .” His question was then interrupted by VRPAC member Dr. Ar- nold Monto, who interjected with a smile and punctuated with an abrupt laugh, “That’s a long question, we need a quick answer.” The answer provided by the Pfizer official was, “I would say there is no established correlate of protection.” Monto then thanked the Pfizer official for her “quick answer”.68 The FDA’s public warnings not to interpret positive antibody tests as evidence of natural immunity is disingenuous. The obvious reason for the FDA to tell people who have recovered from infec- tion that they shouldn’t believe that they have natural immunity is because it serves the policy goal of achieving higher vaccine uptake. “Evidence of exposure to SARS-CoV-2, regardless of the bi- omarker used to assess infection,” noted the authors of a study published in EClinicalMedicine in May 2021, “appears sufficient to indicate protection against reinfection.” (That study conservatively estimated natural immunity to be 95 percent effective in preventing SARS-CoV-2 reinfection after seven months since primary infec- tion.)69 In practical terms, that means that detection of either T cells or antibodies to SARS-CoV-2 is evidence of prior infection, and evi- dence of prior infection is evidence of natural immunity. However, how various immune responses to SARS-CoV-2 co- ordinate to protect people from infection and disease is not pre- cisely known, and COVID-19 vaccines do not induce equivalent im- mune responses. The FDA’s ‘Immunobridging’ Fraud 41 Therefore, the FDA’s warning not to interpret antibodies as ev- idence of vaccine-induced immunity is sincere. Antibodies do not equal immunity, and the FDA knows it. One thing that is clear from the scientific literature is that pro- tection is largely—if not predominantly—dependent on cellular im- mune responses that are distinct from humoral immunity, which re- fers specifically to the protection from antibodies circulating in the blood. Another thing that is clear in the literature is that effective im- munity is not dependent on a high level of circulating antibodies. In fact, it was known well before the FDA first authorized COVID-19 vaccines for emergency use that a high level of antibody is associ- ated with severe disease and death. Individuals with highly effective immune responses generally do not develop a very high level of neutralizing antibodies in their blood; high titers are rather associated with a dysfunctional immune response and severe disease. Indeed, it has been a consistent observation in the literature that a higher level of IgG antibodies in patients is associated with more severe COVID-19, which association exists independently from age, whereas people whose immune systems are highly effective at fighting the virus tend to produce a comparatively low level of an- tibodies.70 As researchers from La Jolla Institute for Immunology observed in September 2020, “the bulk of evidence” pointed to “a much big- ger role for T cells than antibodies.” They observed that “in gen- eral, people who mounted a broader and well-coordinated adaptive response tended to do better.” They cautioned that, therefore, ra- ther than focusing narrowly on inducing an IgG antibody response to the SARS-CoV-2 spike protein, “vaccine candidates should aim to elicit a broad immune response that includes antibodies, helper and killer T cells to ensure protective immunity.” The FDA’s ‘Immunobridging’ Fraud 42 “In line with what other research teams had found before,” La Jolla scientists found that “antibodies don’t seem to play an im- portant role in controlling acute COVID-19. Instead, T cells and helper T cells in particular are associated with protective immune responses.”71 Again, the FDA acknowledges in its EUA decision memoran- dum that there is no specific level of neutralizing antibodies that has been correlated with protection from COVID-19, yet it at- tempts to excuse its unscientific leap of logic by ridiculously assert- ing that the antibody levels used for its “immunobridging” evalua- tion “do not need to be scientifically established to predict protec- tion”; they only need to be “clinically relevant to the disease”.72 In other words, the FDA asserted that it was reasonable to as- sume that a certain level of neutralizing antibodies equates to im- munity in the absence scientifically established correlates of immunity and despite the known fact that a high level of antibodies correlates to se- vere disease. But that is itself an absurdly unscientific assertion. To illustrate the glaring logical fallacy, anti-nucleocapsid anti- bodies are also “clinically relevant”, but the FDA does not employ the very same reasoning to claim that therefore detection of a high level of anti-nucleocapsid antibodies in the blood equates to im- munity. To try to justify its scientifically fraudulent approach, the FDA cites “regulatory precedent” with other vaccines. However, just be- cause the FDA has perpetrated scientific fraud in the past does not excuse its present reliance on scientific fraud to authorize COVID-19 vac- cines for “emergency use” in infants and toddlers.73 Ignoring Waning Immunity Additionally, the antibody titers relied upon by the FDA as the primary basis for its emergency use authorization were measured The FDA’s ‘Immunobridging’ Fraud 43 only one month after administration of the third dose in infants and toddlers, even though the FDA knows that the immunity in- duced by COVID-19 vaccines wanes rapidly, resulting in loss of protection against infection within several months of vaccination.74 The FDA also knows that there is no reason to expect the re- sults of vaccination to be different for infants and toddlers. As the FDA admits in the document, “Observational studies have indicated waning effectiveness of mRNA COVID-19 vaccine primary series against symptomatic infection over time for all age groups for which they are authorized, as well as reduced and more rapidly waning effectiveness against symptomatic infection caused by the Omicron variant.” The FDA cites studies indicating that vaccine effectiveness in children aged five to eleven years fell from 60 percent within the first month since completion of the primary two-dose series to just 29 percent within two months.75 Associated with the rapidly waning immunity observed in vac- cinated people is a decline in antibody titers, which by the FDA’s own reasoning equates to a loss of protective immunity.76 Hence, the FDA must anticipate that neutralizing titers at two months since completion of the three-dose series in younger children will be sig- nificantly lower than those observed in the lab at one month, yet the FDA accepted measurements only up to one month later anyway, as though the titers observed at this early timepoint could be expected to persist indefinitely. In other words, for the purposes of its risk-benefit analysis, the FDA willfully blinded itself to the known waning of vaccine-in- duced immunity, While effectiveness against severe outcomes has been shown to outlast protection against infection, this immune protection, too, wanes rapidly in comparison to natural immunity. That is precisely The FDA’s ‘Immunobridging’ Fraud 44 why “public health” officials ultimately decided to start recom- mending “booster” shots for fully vaccinated people.77 While ignoring observations of rapidly waning immunity for the purpose of its immunogenicity analysis, the FDA admitted that this is the expected result from vaccinating infants and toddlers. The memorandum explicitly acknowledges that the FDA’s risk-benefit analysis is limited by the unknown duration of the presumed vaccine effectiveness for this age group. In other words, the FDA’s conclusion that the benefits of vac- cination would outweigh the risks rests on the false assumptions that a high level of vaccine-induced antibodies equate to strong protec- tion and that this protection will endure indefinitely. At the same time, the FDA admits that, based on the experience with older age groups, “it is likely that a booster dose will be needed in addition to the three-dose primary series” in children aged six months to four years.78 The FDA makes that statement as though a fourth dose would be a sufficient final dose, but that is wrong, too. On the contrary, studies have observed a similarly rapid waning of immunity after booster shots as observed after the primary two-dose series. As VRBPAC member Dr. Paul Offit acknowledged in an article in the New England Journal of Medicine on April 28, 2022, contrary to how the vaccines were originally sold to the public, it was always “expected” that vaccine effectiveness against symptomatic infec- tion would be short-lived. Studies by Pfizer, Offit noted, had shown that a booster dose could restore protection against mild illness, but “unfortunately, this protection did not persist for more than a few months.”79 Thus, FDA officials must also anticipate that not just a single booster shot but routine booster shots for the rest of these children’s lives are likely to be required to sustain any protection that Pfizer’s vaccine might confer. The FDA’s ‘Immunobridging’ Fraud 45 But the FDA did not factor the risk of routine vaccinations into its ostensible risk-benefit analysis—as though having to routinely get booster shots every few months would pose no additional risk to young children than the primary three-dose series alone. Obviously, the FDA did not assess the risk to children of having to repeatedly get COVID-19 shots throughout their lifetimes. Gov- ernment regulators and “public health” officials are completely blind to the long-term health effects of repeated immune stimula- tion by vaccination. They have absolutely no scientific basis for say- ing that the benefits of a routine vaccination regimen would out- weigh the risks. It is faith-based policymaking. As the European Medicines Agency (EMA) has warned, relying on “repeated vaccinations within short intervals would not repre- sent a sustainable long-term strategy.” Such an approach could po- tentially result in “problems with the immune response” due to “overloading the immune system with repeated immunization.”80 Furthermore, as will be discussed in detail shortly, the FDA’s risk-benefit analysis ignores repeated observations in the literature of negative vaccine effectiveness for both adults and children within several months of vaccination.81 In sum, the FDA’s decision was based upon the false assumption that a high antibody titer within the first month of becoming fully vaccinated equates to strong protection and upon willful ignorance of the scientific evidence that COVID-19 vaccines have a detrimental long-term effect on immunity, including among children. Indeed, as we will also come to shortly, studies have confirmed that an immunological phenomenon known in the literature as “original antigenic sin” is a real problem with mRNA COVID-19 vaccines. The FDA’s ‘Immunobridging’ Fraud 46 Measuring Antibodies Against an Extinct Viral Strain The scientific fraud of the FDA’s “immunobridging” analysis does not end there. The FDA not only fallaciously assumed that Pfizer’s vaccine would be effective for preventing COVID-19 in very young children based on antibody titers, but the levels meas- ured in the lab were neutralizing titers against the original Wuhan strain of the virus, which is now extinct outside of laboratories, and not on measurement of neutralizing antibodies against the currently circu- lating “Omicron” variant (or any of its subvariants). This was done even though the FDA knows that the vaccines induce far lower neutralizing antibody titers against Omicron than against the ancestral strain. To conduct its risk-benefit analysis based on the neutralization of the ancestral strain and then generalize those results to draw the conclusion that the vaccine will therefore be effective against Omicron is yet another example of brazen sci- entific fraud: the FDA is fully cognizant that this is not merely a non sequitur but demonstrably false. As already discussed, the FDA acknowledges that vaccine -in- duced immunity wanes more rapidly against the Omicron variant than had occurred with prior variants. As described in the decision memorandum, the FDA’s immuno- bridging evaluation “was based on SARS-CoV-2 neutralizing anti- body responses at 1 month post Dose 2 or Dose 3 in two separate age groups (6-23 months; 2-4 years) compared to the neutralizing antibody responses in a random subset of participants 16-25 years of age at 1 month post Dose 2 . . . , as measured by 50% neutraliz- ing antibody titers . . . against the reference strain (USA_WA1/2020).”82 (Emphasis added.) That reference strain was isolated by CDC researchers from the very first patient diagnosed with COVID-19 in the US, which oc- curred in Washington state on January 20, 2020.83 The FDA’s ‘Immunobridging’ Fraud 47 That strain was genetically similar to the first strain isolated by researchers in Wuhan, China, following the initial outbreak of COVID-19 there. It is the ancestral Wuhan strain of the virus, which is the strain that was circulating early in the pandemic, before it was displaced by subsequent variants like Alpha, Beta, Delta, and now Omicron. The COVID-19 vaccines were specifically designed to elicit an antibody response to the spike protein of that ancestral strain, not to any of the “variants of concern” that have since emerged. This is specified elsewhere in the memorandum by the FDA: “For each age group, SARS-CoV-2 neutralizing [antibody titers] and seroresponse rates were assessed against the reference strain (USA_WA1/2020) upon which the vaccine was based in the evaluable immunogenicity population without evidence of prior SARS-CoV-2 infection.”84 (Emphasis added.) The FDA did this despite being fully aware that the Omicron variant significantly escapes the neutralizing antibodies that vac- cines elicit against the spike protein of the ancestral strain.85 In fact, the FDA conducted a secondary “exploratory analysis” by requesting data from Pfizer on the immunogenicity of its vac- cine against the Delta and Omicron variants. Pfizer submitted such data, which were obtained using a “non-validated” antibody neu- tralization assay, and the results unsurprisingly showed that neutral- izing antibody titers against the Omicron variant were, in the words of the FDA, “notably lower”. That’s a notable understatement. Table 18 of the document pre- sents the geometric mean titer (GMT) values, representing the con- centration of antibodies in the blood capable of neutralizing the virus, against those three variants. For children aged six months to one year, the GMT was 640.0 against the ancestral strain, 606.3 against Delta, and 127.5 against Omicron. A similar result was seen The FDA’s ‘Immunobridging’ Fraud 48 with children aged two to four years, where the values were 471.4 for both the ancestral strain and Delta and 82.5 with Omicron. Thus, neutralizing titers against the variant presently circulating among humans were between four to six times lower than against the now-extinct ancestral strain. Yet, the FDA conducted its immu- nogenicity evaluation as though it was still only the Wuhan strain circulating. This is blatant scientific fraud perpetrated specifically to accom- plish the predetermined goal of authorizing the vaccine for “emer- gency use” in infants and toddlers prior to the completion of phase three clinical trials. The fact that the FDA deliberately ignored the relative lack of vaccine effectiveness against Omicron for the purpose of its im- munogencity evaluation is specified further into the document, where the FDA again understatedly points out that “neutralizing antibody GMTs against the Omicron variant were lower than those against the ancestral strain and Delta variant”. Nevertheless, the FDA’s immunobridging “success criteria” were met for both age groups “based on SARS-CoV-2 neutralizing antibody GMTs and seroresponse rates at 1-month post-Dose 3 evaluated against the USA_WA1/2020 reference strain and compared to participants 16-25 years of age randomly selected from study C4591001.”86 (Emphasis added.) The FDA also notes that the purpose of revising the study pro- tocol to add a third dose was specifically to meet its success criteria for neutralizing titers against the ancestral strain since the criteria were not met for either age group following administration of the second dose.87 It is apparent that if the FDA had based its decision on neutral- izing titers against the circulating Omicron variant that the criteria would also not have been met even with the revised protocol. The result would have been the vaccine not receiving authorization for The FDA’s ‘Immunobridging’ Fraud 49 “emergency use” in infants and toddlers. This in turn helps to ex- plain why the FDA opted to perpetrate such glaring scientific fraud. As a final point, the FDA’s reliance on this scientifically fraudu- lent immunobridging analysis, which excluded previously infected children for the obvious reason that the resulting immune response would be attributable to immunologic memory from prior infec- tion, results in a risk-benefit analysis that falsely assumes that vac- cination will be of equal benefit for children who are already naturally immune as for immunologically naïve children. Once again, the conclusion is inescapable that the FDA set out to authorize the vaccine for very young children rather than to con- duct a serious and scientific risk-benefit analysis to determine whether the vaccine should receive authorization. The Politically Predetermined Outcome of the FDA’s “Anal- ysis” Indeed, it was a foregone conclusion in the Executive Branch of the federal government that COVID-19 vaccines would be made available to infants and toddlers. White House COVID-19 Response Coordinator Ashish Jha publicly declared on June 3, “We expect that vaccinations will begin in earnest as early as Tuesday, June 21, and really roll on throughout that week. . . . And our expectation is that within weeks, every par- ent who wants their child to get vaccinated will be able to ge t an appointment.”88 Before the FDA even conducted its evaluation, the Biden ad- ministration had procured 10 million doses to be immediately avail- able for this age group, with millions of additional doses to be pro- cured in the following weeks. That procurement of COVID-19 vaccines for children under the age of five years was announced by the White House on June 9 in anticipation of the FDA’s The FDA’s ‘Immunobridging’ Fraud 50 authorization, prior to the VRBPAC meeting on June 15 at which the FDA presented its briefing document detailing its ostensible risk-benefit analysis, and more than a week prior to the FDA’s emer- gency use authorization on June 17.89 These moves followed the resignations in September 2021 of the director of the FDA’s Office of Vaccines Research and Review, Dr. Marion Gruber, and her deputy director, Dr. Philip Krause. They resigned reportedly in protest of political pressure on the FDA from the Biden administration to authorize booster shots for emergency use among the general population.90 In an email to the director of the FDA’s Center for Biologics Evaluation and Research, Gruber complained of being publicly pressured by vaccine manufacturers including Pfizer to authorize booster doses, despite the data they presented suggesting “that boosters are not needed.”91 (The debate among policymakers at the time was whether booster shots were needed since continued protection against se- vere disease and death from the Delta variant was observed despite rapid waning of protection against infection. As already noted, the decision to recommend boosters was ultimately made due to ob- servations of waning protection against severe disease and death, too.) Gruber expressed further dismay that the Biden administration was trying to impose timelines “that make no sense”. She specifi- cally referred to an announcement from the White House that FDA-authorized booster shots were expected to be available to people on September 20, 2021.92 51 he FDA decision memorandum states that the combined Phase 2 and Phase 3 trials for the Pfizer vaccine included 4,526 participants aged six months through four years who were randomized to receive two doses of the vaccine three weeks apart, with twice as many children in the vaccinated group as in the placebo group. Children with a history of prior SARS-CoV-2 infec- tion were not excluded. As already discussed, the result was that the two-dose regimen failed to induce a sufficient antibody response to meet the FDA’s criteria for its immunobridging analysis, so “the protocol was amended to add a third primary series dose” at least eight weeks after the second dose.93 In addition to its scientifically fraudulent immunobridging eval- uation, the FDA looked at preliminary data on vaccine efficacy stratified into two different age groups. The measured endpoint for this analysis was laboratory-confirmed symptomatic SARS-CoV-2 infection. The first efficacy population included 1,776 children aged six to twenty-three months, with 1,178 children in the vaccine group and 598 in the placebo group. The second efficacy population included 2,750 children aged two to four years, with 1,835 in the vaccine group and 915 in the placebo group.94 To estimate vaccine efficacy, the FDA considered only children diagnosed with COVID-19 at least seven days after administration T The Absence of Evidence for Vaccine Efficacy 52 of the third dose, thus excluding most COVID-19 cases that oc- curred during the trial. For the efficacy population of children aged six to twenty- three months, the subpopulation included for analysis totaled only 555 children, with 376 in the vaccine group and 179 in the placebo group. There were three confirmed cases of COVID-19 post-dose- three in this subpopulation, with one case in the vaccine group and two in the placebo group, all occurring during a time of Omicron circulation. The result was an efficacy estimate of 75.6 percent, but this es- timate had wide confidence intervals, ranging from negative 369.1 percent to 99.6 percent. Essentially, the confidence intervals mean that there is a 95 percent probability that the true effective- ness falls somewhere between the negative and the positive values. Since the range includes numbers on both sides of zero, the result is not statistically significant.95 In other words, the estimated efficacy was statistically indistinguish- able from zero and not inconsistent with the opposing hypothesis that vaccination of children in this age group will place them at higher risk of symptomatic infection. For the efficacy population of children aged two to four years, the subpopulation included for analysis totaled 860 children, with 589 in the vaccine group and 271 in the placebo group. There were seven COVID-19 cases, with two in the vaccine group and five in the placebo group, all occurring during a time of Omicron circula- tion. The result was an estimated vaccine efficacy of 82.4 percent, but again with wide confidence intervals, ranging from negative 7.6 percent to 98.3 percent. Thus, once again, according to its own analysis, the FDA had no evidence of significant vaccine efficacy against symptomatic infec- tion. The Absence of Evidence for Vaccine Efficacy 53 The FDA understatedly acknowledges this by saying that inter- pretation of the data “is limited” because vaccine efficacy at least seven days after administration of the third dose “cannot be pre- cisely estimated due to the limited number of cases accrued during blinded follow-up, as reflected in the wide confidence intervals as- sociated with the estimates.”96 Ignoring a Higher Rate of Severe COVID-19 and Repeated Disease Among Vaccinated Children Although the FDA based its efficacy analysis only on COVID-19 cases diagnosed seven or more days after receipt of the third dose, the decision memorandum presents preliminary data on all COVID-19 cases that occurred throughout the trial. Looking at the full dataset, for the trial population of children aged six to twenty-three months, there were 98 cases of COVID-19 in the vaccine group and 58 cases in the placebo group, or 8.3 per- cent of vaccine recipients compared to 9.7 percent of placebo re- cipients. This resulted in an estimated vaccine efficacy of just 14 percent, which again was not statistically significant, with confi- dence intervals ranging from negative 21.2 percent to 38.4 percent. For the trial population of children aged two to four years, there were 127 cases in the vaccine group and 92 cases in the placebo group, or 6.9 percent of vaccine recipients compared to 10 percent of placebo recipients. This resulted in an estimated vaccine efficacy of 32.6 percent. This result was statistically significant, with confi- dence intervals ranging from 10.8 percent to 48.8 percent, but this is well below the FDA’s originally stated requirement that in order to obtain emergency use authorization, COVID-19 vaccines would need to achieve an efficacy of at least 50 percent.97 Additionally, the FDA decision memorandum includes data on cases of severe COVID-19. Astonishingly, the data show that among The Absence of Evidence for Vaccine Efficacy 54 children aged two to four years, there was a higher rate of severe COVID-19 in the vaccine group, and yet the FDA offers no com- ment about this. Nor does the FDA comment on the fact that the only patient in this age group hospitalized for COVID-19 was vac- cinated, or the fact that there was a higher rate of repeated SARS-CoV-2 infections in the vaccine group. In the efficacy population for children aged six to twenty- three months, there was just one severe case, a fourteen-month-old placebo recipient reporting symptoms including fever and cough. After an initial negative test for SARS-CoV-2, symptoms persisted, and a second test was positive with “coin fection with human rhi- novirus/enterovirus”. Nine days after the positive test, the child had a seizure and went to the emergency department, where the child was found to have a temperature of 38.4 degrees Celsius and a heart rate of 172 beats per minute. After observation, the child was discharged the same day, and all symptoms were reported as resolved eight days after the visit. The FDA notes that the trial in- vestigator “thought the fever could be attributable to COVID-19 illness”, and the participant “met the criteria for severe COVID-19 because of an increased heart rate”.98 The data from the efficacy population for children aged two to four years is more startling. The FDA notes that seven cases in this age group met the criteria for severe COVID-19, with six cases in the vaccine group and one in the placebo group, all occurring after administration of the second dose. The only patient hospitalized due to COVID-19 was a vaccine recipient. Thus, the rate of severe COVID-19 among the 1,835 vaccine recipients was 0.33 percent compared to a rate among the 915 pla- cebo recipients of 0.11 percent. The rate of COVID-19 hospitalization among vaccine recipi- ents was 0.05 percent, whereas the number of hospitalizations among placebo recipients was zero. The Absence of Evidence for Vaccine Efficacy 55 The FDA offers no comment about the data showing a three- times higher rate of severe disease among vaccine recipients, plus showing that the only patient hospitalized for COVID-19 was vac- cinated.99 As mentioned, the data also show a higher rate of multiple infections among vaccine recipients aged two to four years. For the efficacy population of children aged six to twenty- three months, there were three participants in the vaccine group and three in the placebo group who “developed more than one vi- rologically and clinically confirmed episodes of symptomatic COVID-19 disease.” Thus, the rate of repeated symptomatic infection among the 1,178 participants assigned to receive the vaccine was 0.25 percent, compared to a rate among the 598 participants originally assigned to receive the placebo of 0.5 percent. However, by the time the FDA conducted its ostensible “analy- sis” of the data, the trial was already unblinded, and placebo recip- ients had already been given the option to be vaccinated. The FDA notes that two of the “placebo” recipients who had repeated symp- tomatic infections had received three doses of vaccine following two doses of placebo. It isn’t clear from the information presented in the decision memorandum whether the reinfections among those originally assigned to the placebo group occurred before or after unblinding and vaccination. The FDA also notes that all three vaccine recipients with repeat infections received all three doses. If those in the “placebo” group also completed the three-dose series prior to their own reinfections, it would suggest that this regimen places children at higher risk of repeated infections.100 The data for the efficacy population of children aged two to four years are once again more startling. There were five repeat cases of COVID-19 in the vaccine group compared to one in the The Absence of Evidence for Vaccine Efficacy 56 placebo group. Thus, the rate among the 1,835 participants as- signed to the vaccine group was 0.27 percent versus a rate among the 915 participants originally assigned to receive the placebo of 0.11 percent. Once again, the FDA offers no comment about the data show- ing more than twice the rate of repeated symptomatic infections among vaccine recipients.101 These findings suggesting an increased risk to vaccine recipients of severe disease and of repeated disease may have no statistical significance, as the study was not powered to determine vaccine efficacy against these outcomes, but it should nevertheless be deeply concerning to every rational observer that the FDA would communicate to the public that the vaccine is “effective” based on this abysmal data. Ignoring Negative Vaccine Effectiveness in Children In summarizing its risk-benefit analysis, the FDA claims that the data “support the effectiveness” of the three-dose primary series of Pfizer-BioNTech COVID-19 vaccine for children aged six months through four years. However, that is false since the supporting data that the FDA is referring to are the data used for its scientifically fraudulent “im- munobridging” analysis, from which “vaccine effectiveness was in- ferred”. Again, the FDA had no data showing that receipt of three doses of the vaccine conferred significant protection against sympto- matic infection, and it ignored the data showing that severe disease, hospitalization, and repeated infections occurred at a higher rate among vaccinated children in the two-to-four age group. Additionally, while acknowledging observations of rapidly wan- ing immunity, the FDA chose to ignore evidence from the scientific The Absence of Evidence for Vaccine Efficacy 57 literature that COVID-19 vaccine effectiveness against the Omi- cron variant becomes significantly negative after several months. A study by researchers in Denmark published at the online pre- print server medRxiv on December 23, 2021, found that effective- ness among fully vaccinated individuals waned rapidly from about 55 percent to no significant effectiveness after just one month. Moreover, three months after receipt of the second dose, effective- ness became significantly negative, meaning that fully vaccinated people were at higher risk than unvaccinated people of becoming infected with SARS-CoV-2.102 (A preprint study is one that has not yet been peer-reviewed. During the pandemic, there has been an increased reliance on pre- prints due to the need to urgently get new discoveries out, and pub- lic scrutiny of such papers has itself served as a form of peer re- view, resulting in retractions in some cases. In other instances, pa- pers end up becoming published in peer-reviewed journals. As an The Absence of Evidence for Vaccine Efficacy 58 illustration of how preprints are commonly relied upon, in its deci- sion memorandum, the FDA references two preprint studies for its statement that “some studies suggest that the added protection from vaccination is more limited for those with prior infection within 6 months.” In other words, as the FDA admits, the risk-ben- efit analysis of vaccination for people with natural immunity is not the same as for people who are immunologically naïve, yet its own risk-benefit analysis inherently presumes all children are without any immunity anyway.103) The authors of the Danish study suggested that the negative effectiveness could be due to fully vaccinated people engaging in behaviors that place them at higher risk of exposure, which is plau- sible given the societal restrictions placed by the government upon unvaccinated people. However, researchers in Canada similarly finding negative vaccine effectiveness acknowledged that it could also indicate a true detrimental effect of vaccination. The Canadian study was published at medRxiv on January 1, 2022. Unlike the Danish study, it found that receipt of two doses of COVID-19 vaccines “was not protective against Omicron at any point in time”. While a booster dose provided “some protection in the immediate term”, effectiveness peaked at only 37 percent, and the study was not designed to determine the duration of that effect. Moreover, among the fully vaccinated but unboosted, statistically sig- nificant negative effectiveness was observed after just four months since receipt of the second dose. The authors acknowledged that this finding was possible evi- dence that “antigenic imprinting” by vaccination had a detrimental long-term effect on immunity.104 The Absence of Evidence for Vaccine Efficacy 59 The same researchers subsequently published a second version of their study at medRxiv. This time, they estimated vaccine effec- tiveness based only on symptomatic infections recorded in Decem- ber 2021 rather than also including asymptomatic infections. Alt- hough mRNA COVID-19 vaccines lost significant effectiveness against symptomatic infection with Omicron by six months since receipt of the second dose, the estimated effectiveness through about eight months did not fall below zero. The authors omitted the acknowledgement of possible anti- genic imprinting in this version and explained away their earlier The Absence of Evidence for Vaccine Efficacy 60 finding as the result of behavioral differences between vaccinated and unvaccinated people. As they reasoned: If asymptomatic vaccinated individuals are more likely to be tested (e.g., healthcare workers, individuals exposed to cases), vaccinated Omicron cases would be more likely to be identified compared to unvac- cinated Omicron cases, leading to an underestimate of VE [vaccine effectiveness]. Restricting the analysis to symptomatic individuals, as presented here, should mitigate this potential source of bias.105 In other words, their argument is that unvaccinated people really did have a higher rate of infection, it just wasn’t showing up in the data because they weren’t getting tested at the same rate. However, that was merely a hypothesized selection bias, and while this is plausible given the societal restrictions imposed by the Cana- dian government on unvaccinated people, they did not demonstrate that vaccinated people were in fact more likely to be tested and for their infections to therefore be identified. It might also be that unvaccinated people were equally if not more likely to be tested since a negative test may have been required of them in lieu of a vaccination record for their participation in society. For example, unvaccinated Canadian truckers re-entering the country were required to produce a negative PCR test result and to be quarantined if testing positive, whereas effective Novem- ber 30, 2021, fully vaccinated truckers were exempted from the test- ing requirement.106 Also, a failure to find negative vaccine effectiveness against dis- ease is not necessarily at odds with a finding of negative vaccine effectiveness against infection within the same time frame. As already noted, vaccine effectiveness against severe disease is known to be The Absence of Evidence for Vaccine Efficacy 61 more durable than effectiveness against infection, and it makes sense that effectiveness against symptomatic infection would out- last effectiveness against any infection. In other words, contrary to their own interpretation, the findings of their updated version do not invalidate the findings of their original study. While those studies highlighted the ability of a booster shot to restore protection in the short-term, data published by the UK Health Security Agency on December 31, 2021, showed that the effectiveness of two doses of Pfizer’s COVID-19 vaccine against symptomatic infection dropped from an estimated maximum of 70 percent to about 10 percent within five months since receipt of the second dose; and while a booster dose of either Pfizer’s or Moderna’s mRNA vaccine restored protection to a maximum of 75 percent, this protection also waned rapidly, dropping below 50 percent after just ten weeks.107 The Absence of Evidence for Vaccine Efficacy 62 Studies have also been published showing significant negative effectiveness of COVID-19 vaccines specifically for children. A study by researchers from the New York State Department of Health published at medRxiv on February 28 showed rapidly waning vaccine effectiveness against Omicron infection among children. Among adolescents aged twelve to seventeen, effective- ness dropped from 76 percent initially to under 50 percent after just five weeks since receipt of the second dose. For children aged five to eleven, vaccine effectiveness dropped from 65 percent to just 12 percent after only one month, and there- after the data indicated significantly negative effectiveness. Within six weeks of the second dose, vaccine effectiveness fell to negative 10 percent, and within seven weeks, it plummeted further to nega- tive 41 percent. For the older age group of twelve to seventeen years, there was also waning of vaccine effectiveness from 76 percent to 46 percent. The authors asserted that there was nevertheless “sustained The Absence of Evidence for Vaccine Efficacy 63 protection against severe disease” among adolescents, but that de- scription hardly seems appropriate considering that their data also showed vaccine effectiveness against severe disease falling from 94 percent to 73 percent after just two months. Vaccine effectiveness against hospitalization among younger children lost statistical sig- nificance within the same time frame. The health department researchers relegated their comment about the observed negative effectiveness to a footnote, stating that estimates of negative effectiveness “likely reflect estimator instabil- ity and/or residual confounding, as opposed to true relatively -in- creased risk for those vaccinated.”108 However, this dismissal is irresponsibly speculative since this finding could very well indicate a detrimental effect of COVID‑19 vaccines in children, especially given the repeatability of the finding coupled with separate studies demonstrating that a detrimental “immune imprinting”, or “original antigenic sin”, is a real problem with these pharmaceutical products (as discussed in more detail in the next section). The data from New York were also published in JAMA on May 13. Gone from this version were the corresponding estimates of vaccine effectiveness, but the reported incident rate ratios pre- sented, which compare the rate of COVID-19 cases among fully vaccinated children with unvaccinated children, still show nega- tive vaccine effectiveness for children aged five to eleven within six weeks of receipt of the second dose. Within seven weeks, the neg- ative effectiveness, indicated by an incident rate ratio below “1”, reached statistical significance. Once again, the health department researchers demonstrated reckless disregard for the health of children by dismissing this find- ing as an artifact, bewilderingly concluding that their findings “sup- port efforts to increase vaccination coverage in children and ado- lescents”.109 The Absence of Evidence for Vaccine Efficacy 64 This is a useful illustration of how authors’ conclusions fre- quently are either unsupported or contradicted by their own data. It also illustrates the tendency of “public health” officials to succumb to confirmation bias, accepting data that suppo rts their policy rec- ommendations while willfully ignoring findings that do not, such as this data suggesting that by urging parents to vaccinate their chil- dren, they might be ultimately causing these children to be more sus- ceptible to COVID-19 throughout their lifetimes. Another illustration of official confirmation bias comes from a separate study by CDC researchers also published in JAMA on May 13. Their data showed that vaccine effectiveness for children aged five to eleven years fell from 60 percent to 29 percent within two months, which was the extent of the observational follow-up for this age group. The Absence of Evidence for Vaccine Efficacy 65 Furthermore, the study showed negative vaccine effectiveness for children aged twelve to fifteen years by five months since receipt of the second dose.110 Yet another study observing negative vaccine effectiveness was published at medRxiv on July 11, 2022. Using official UK govern- ment data, they observed a recent significant increase in the risk of hospitalization and in the case fatality rate, which is the rate of deaths per reported cases (not to be confused with the infection fatality rate, which is deaths per estima ted infections). There was also a significant increase in the proportion of cases in people aged 50 years or older, as well as an increase in the proportions of hos- pitalizations and deaths among people aged 75 years or older. As stated in the abstract, “The vaccine effectiveness (VE) for the third dose was in negative [sic] since December 20, 2021, with a significant increased proportion of SARS-CoV-2 cases hospitaliza- tions and deaths among the vaccinated; and a decreased proportion of cases, hospitalizations, and deaths among the unvaccinated.” The Absence of Evidence for Vaccine Efficacy 66 The authors concluded that there had been no discernible vac- cine effectiveness among triple-vaccinated people aged 18 years or older since the end of last year. They stated that the “increased proportion of cases with significantly increased risk of hospitaliza- tions and deaths among the elderly population during the Omicron variant surge underscores the need to prevent infections in the el- derly irrespective of vaccination status”.111 That was a diplomatic way of saying that the government’s rec- ommendation for people to get fully vaccinated plus boosted had failed to reduce the risk to the elderly, which is really an understate- ment since the data indeed indicated an increased risk to triple-vac- cinated people. Further into the body of the study, the authors noted that the UK government’s weekly surveillance reports had shown “a trend of increased cases in the vaccinated third booster population than the unvaccinated population during the Omicron variant surge. These reports highlight an alarming trend of increased hospitaliza- tions and deaths among the vaccinated third dose population until they stopped reporting the underlying data after March 27, 2022.” (Empha- sis added.) Draw your own conclusion about why the UK may have decided to stop publishing the data. The data for people aged 18 years or older “showed waning of vaccine effectiveness for the two doses during the Delta variant surge (since September 2021) with negative vaccine effectiveness for the infections during the Omicron variant surge in all the vac- cinated groups including the third dose population since Decem- ber 20, 2021.” There was “a significantly higher proportion of infections in vaccinated with two doses (including all vaccinated) than the un- vaccinated during the Delta variant surge”, and “the vaccinated with third dose had significantly higher infection rates versus the The Absence of Evidence for Vaccine Efficacy 67 vaccinated with two doses and unvaccinated during the Omicron variant surge”. This negative vaccine effectiveness “was associated with a sig- nificantly higher proportion of hospitalizations in vaccinated with two doses than unvaccinated during the Omicron variant surge (since January 2022), a higher proportion of deaths in vaccinated two doses than unvaccinated (since October 2021), and higher pro- portion of hospitalizations and deaths in vaccinated with the third dose than vaccinated with two doses and unvaccinated during Omi- cron variant surge (since February 2022).” The authors emphasized that their findings “have to be inter- preted with great caution because the randomized controlled trials for the COVID-19 vaccines did not show demonstrable benefits to preventing hospitalization and/or deaths and were not adequately powered to study those outcomes.” In the absence of data from randomized controlled trials demonstrating vaccine effectiveness against hospitalization and death, researchers were relying on ob- servational studies, which are prone to selection bias. However, the authors also provided a simple and likely explana- tion for their observation that unvaccinated people were at lower risk than vaccinated people, which was that the decrease in cases among the unvaccinated was “probably due to protection from their prior natural infections that were already shown to give lasting immun- ity”.112 Thus, they implicitly recognized superior natural immunity as an opportunity cost of vaccination, which they suggested was a probable explanation for their observation of negative vaccine effectiveness. For the FDA to authorize Pfizer’s COVID-19 vaccine for emer- gency use in children aged six months to four years despite an absence of evidence of vaccine efficacy for this age group and evidence of negative vaccine effectiveness within several months for everyone aged five and up is an act of criminal negligence, especially in light of research The Absence of Evidence for Vaccine Efficacy 68 confirming that an immunological phenomenon known as “origi- nal antigenic sin” is a real problem with these pharmaceutical prod- ucts. Ignoring the Problem of “Original Antigenic Sin” with COVID-19 Vaccines “Original antigenic sin” is a term used in the literature to de- scribe a phenomenon in which the initial immune response to an infection or vaccination prejudices the immune response to subse- quent infections with different strains to be suboptimal relative to the immune response of immunologically naïve individuals. There is an “immune imprinting” that occurs so that the immune response re- mains fixated on the originally infecting strain rather than adapting to become more specific to the newly infecting variant. This has been an obstacle to the redesign of COVID-19 vac- cines to induce immune responses specific to SARS-CoV-2 vari- ants. This was noted by the authors of a study published in the journal Cell on January 24, 2022. A booster dose of an mRNA vac- cine modified to express the spike protein of the Beta variant still resulted in neutralizing antibodies more specific to the original Wu- han strain, suggesting that “some degree of immune imprinting, or preferential responses to the viral variants initially encountered by the immune system, may affect the development of antibodies against new viral variants.”113 Similarly, a study comparing the antibody response in macaques from either the Moderna mRNA COVID-19 vaccine or a modified version designed to induce antibodies specific to the spike protein of the Omicron variant found no protective advantage of the mod- ified vaccine.114 Federal regulators and “public health” officials are not unaware of this problem. Dr. Paul Offit, a member of the FDA’s vaccine The Absence of Evidence for Vaccine Efficacy 69 advisory committee, astonishingly admitted in an article published in the New England Journal of Medicine on April 28, 2022, that it was always “expected” that vaccine effectiveness against symptomatic infection would be short-lived, and that, “unfortunately”, the re- stored protection from administration of a booster dose also “did not persist for more than a few months.” Furthermore, he warned that vaccine recipients of all age groups “are at risk for the theoretical problem of an ‘original anti- genic sin’—a decreased ability to respond to a new immunogen be- cause the immune system has locked onto the original immuno- gen.” Continuing, he noted that “An example of this phenomenon can be found in a study of nonhuman primates showing that boost- ing with an omicron-specific variant did not result in higher titers of omicron-specific neutralizing antibodies than did boosting with the ancestral strain. This potential problem could limit our ability to respond to a new variant.”115 Studies have now confirmed that original antigenic sin is a real problem with COVID-19 vaccines. One piece of early evidence for this problem was the observa- tion that vaccinated individuals who experience “breakthrough” in- fection apparently had an impaired ability to generate antibodies against the nucleocapsid protein of SARS-CoV-2, and one source of data demonstrating this impairment was the initial clinical trial data used by the FDA to authorize Moderna’s mRNA COVID-19 vaccine for emergency use.116 A study by researchers in Norway published at medRxiv on Jan- uary 13, 2022, also found that people whose immune systems were primed by vaccination have impaired cellular immunity relative to people who acquired natural immunity through infection. “The importance of T cells”, the authors emphasized, “has been underlined in previous reports as T cells are necessary for The Absence of Evidence for Vaccine Efficacy 70 rapid and efficient resolution of COVID-19, for protection against severe COVID-19 in settings of low antibody levels, and for rapid viral control in the absence of antibodies—aborting infection in healthy individuals.” In addition to the reduced ability to generate T cells against the virus, the authors observed a “relative lack of neutralizing antibod- ies” in Omicron breakthrough infections. It remained unknown, they pointed out, whether immune systems primed by vaccination and then challenged with Omicron would be able to adapt the an- tibody response to be more specific to this variant.117 The authors of the study in Cell on January 24 observed that infection with a SARS-CoV-2 variant “elicits variant-specific anti- bodies” in immunologically naïve individuals, whereas “prior mRNA vaccination imprints serological responses toward” the an- cestral Wuhan strain “rather than variant antigens.” Vaccination also generates an immune response biased toward production of IgG antibodies, with comparatively “weak IgM and IgA responses” toward the spike protein. “Unlike infection,” the authors commented, “which stimulates robust but short-lived IgM and IgA responses, vaccination shows a pronounced bias for IgG production even at early time points.” This had implications for the inability of the vaccines to induce mucosal immunity that prevents upper respiratory tract infection and transmission of the virus. “Correlates of immunological protection from SARS‑CoV‑2 infection following vaccination or prior infection are still under in- vestigation”, the study authors further noted. This means that just because vaccinated people generate a high level of IgG antibodies that bind to the spike protein of variants—even higher than ob- served in naturally immune people—does not mean that vaccinated people have greater protection. (They do not, as scientists had al- ready long recognized.) The Absence of Evidence for Vaccine Efficacy 71 Additionally, with natural immunity, the binding of IgG anti- bodies to the receptor binding domain (RBD) of the spike protein of variants, which is the specific part of the protein that enables the virus to enter human cells, was observed to improve over time relative to binding to the ancestral strain, “suggesting evolution of the antibody response through at least 7 weeks post-onset of symp- toms”. By contrast, variant binding ratios in vaccinated people “did not change from day 21 onward.” There was “improvement in variant recognitions over time in the infected patients”, but not in vac- cinated people. The study specifically tested the hypothesis that original anti- genic sin occurs with vaccination: To test whether prior exposure to one SARS-CoV-2 RBD variant causes imprinting of humoral immunity, we analyzed plasma from individuals vaccinated with Wuhan-Hu-1 [ancestral strain] antigens and subse- quently infected with Alpha or Delta variants. Despite breakthrough infection with Alpha or Delta viral var- iants, the vaccinated individuals showed patterns of IgG binding to viral variant RBDs similar to those of individuals exposed to only Wuhan-Hu-1.118 In other words, the study findings suggest that while the im- mune responses of people with natural immunity are adaptive, re- sulting in an updated antibody response over time that is more spe- cific to a newly infecting variant, the immune systems of vaccinated people have a comparatively impaired ability to do so and instead become fixated on generating antibodies specific to the extinct an- cestral strain. The Absence of Evidence for Vaccine Efficacy 72 The occurrence of original antigenic sin in vaccinated people was further confirmed by a study whose lead author, Jasmin Quandt, is affiliated with BioNTech, the German company that partnered with Pfizer to produce the Pfizer-BioNTech COVID-19 vaccine. Published on the preprint server bioRxiv on April 1, the study showed that Omicron infection in individuals whose immune systems were primed by vaccination results in a boosting of anti- bodies capable of neutralizing the variant. However, this was not because their immune repertoire was adaptive and ex- panded to become more specific to the variant. Instead, it was simply because the spike protein of Omicron, despite numerous mutations, is similar enough to the spike protein of the original Wuhan strain that vaccinated people’s fixated im- mune response to the ancestral strain still managed to cross-react with the variant. The authors observed “imprinting of the immune response by previous vaccination” so that Omicron breakthrough infection “primarily expands preformed memory B cells that recognize epitopes shared broadly by different variants, rather than inducing new B cells against strictly Omicron-specific epitopes.” In fact, in contrast to the boost in the memory B cell response “directed against epitopes shared by both Wuhan and Omicron BA.1 SARS-CoV-2 variants”, the researchers “could hardly detect only Omicron-RBD-specific” memory B cells. Once again illustrating the institutionalized cognitive dissonance surrounding vaccine products, the authors naturally spun their con- cerning finding of “possible imprinting of the immune response by previous vaccination” into a positive outcome, lauding the ability of vaccinated individuals to still generate immune responses that were at least transiently cross-protective against the Omicron vari- ant.119 The Absence of Evidence for Vaccine Efficacy 73 Somehow, confirmation of the problem of original antigenic sin becomes yet more proof from “the science” that the vaccines are “safe and effective”! The occurrence of original antigenic sin might also help to ex- plain the findings of a study published at medRxiv on April 25, 2022. The study showed that a booster dose in individuals whose immune systems were primed by vaccination results in protection against the Omicron variant “beyond that afforded by the primary series” (which was “low” to begin with), but no such benefit of a booster dose was found in individuals who had already acquired natural immunity prior to getting vaccinated.120 That could be explained simply because the immunological im- printing from infection enables more broadly adaptive immune re- sponses compared to the antigenic fixation that occurs with people whose imprinting is from vaccination. The occurrence of original antigenic sin in vaccinated individu- als was again demonstrated in a study published at bioRxiv on June 2 appropriately titled “Imprinted antibody responses against SARS-CoV-2 Omicron sublineages”. The authors observed an “immunological imprinting” whereby antibodies derived from plasma cells or memory B cells in vac- cinated individuals with an Omicron breakthrough infection were characteristic of a response to the ancestral strain that happened to cross-react with Omicron variants, whereas antibodies in individu- als whose acquired immunity came from primary infection with Omicron were specific to the infecting variant. As the authors bluntly stated, “Omicron breakthrough infec- tions failed to elicit BA.1- or BA.2 [subvariant] RBD-specific anti- bodies”, which findings “illustrate how immunological imprinting from prior exposure, i.e., ‘original antigenic sin’, can strongly affect the response to antigenically novel antigens.” The Absence of Evidence for Vaccine Efficacy 74 Their findings indicated that, due to this immunologic imprint- ing, “an Omicron-based vaccine might only elicit narrow antibody responses directed towards the vaccine-matched antigen”, whereas Omicron infection in people with previously acquired natural im- munity “recalls cross-reactive memory B cells which may further mature over time to enhance their affinity and neutralizing potency against Omicron, but also to broaden their neutralizing activity against past and future variants.”121 A study published in Science on June 14, 2022, further confirmed that the phenomenon of original antigenic sin is relevant for cellu- lar immunity as well as for humoral immunity of vaccinated people. While sterilizing immunity depends on the ability of antibodies to neutralize the virus before it has a chance to infect cells, the au- thors noted that cellular immune responses are critical for limiting and clearing infection and thereby protecting against severe COVID-19. They therefore set out to examine both B cell and T cell responses to Omicron breakthrough infection among triple- vaccinated individuals. (“Sterilizing” immunity refers to protection against infection, distinct from protection against disease in the event of infection. B cells are involved in the production of antibodies, including but not limited to those capable of neutralizing the virus. T cells are also involved in helping B cells produce antibodies, but cellular im- munity includes a wide array of separate responses. B cells get their name from being produced in the bone marrow, while T cells are produced in the thymus.) Looking at B cell immunity, they found that those who were in- fected early in the pandemic with the ancestral Wuhan strain and who subsequently received the two-dose primary series plus a booster dose of COVID-19 vaccine showed “a significantly re- duced” level of antibodies targeting the respective receptor binding domains of Beta, Gamma, and Omicron variants. The Absence of Evidence for Vaccine Efficacy 75 Although this effect was most pronounced for people infected with the Wuhan strain, cross-reactive antibodies against Omicron “were significantly reduced” compared to other variants “irrespec- tive of previous SARS-CoV-2 infection history”. Frequencies of memory B cells against Omicron after receipt of the third dose of vaccine were also significantly reduced. Astonishingly, they found that compared to 8 percent of triple- vaccinated people making no T cell response to the spike protein of the Wuhan strain, 54 percent of triple-vaccinated individuals “made no T cell response” against the part of the spike protein of Omicron where the receptor binding domain is located. This effect was also observed “irrespective of previous SARS-CoV-2 infection history”. Looking beyond that part of the spike protein, they found that 42 percent of triple-vaccinated people “make no T cell response at all” against mutated Omicron peptides that distinguish this variant from the Wuhan strain. (A peptide is a chain of amino acids typi- cally shorter than a protein, either of which can be an “epitope”, which is a molecular region of an antigen capable of eliciting an immune response.) Additionally, breakthrough infection with Omicron “produced potent cross-reactive antibody” against earlier variants, “but less so” against Omicron itself. Triple-vaccinated individuals without Omicron breakthrough in- fection, by contrast, made no neutralizing antibodies against Omi- cron by fourteen weeks after the third vaccine dose, “indicating rapid waning” of the neutralizing antibodies induced by the booster shot. Similarly, fourteen weeks after the third dose, 90 percent of tri- ple-vaccinated individuals without prior history of infection “showed no cross-reactive T cell immunity” against the Omicron spike protein. None of those with a history of infection with the The Absence of Evidence for Vaccine Efficacy 76 ancestral strain showed such immunity, indicating that three doses of vaccine were “unable to boost T cell immunity” against Omi- cron in these individuals. The effect of original antigenic sin was observed to be greatest among those who were infected with the ancestral strain and then later got fully vaccinated and boosted. Whereas Omicron break- through infection was seen to boost cross-reactive antibodies capa- ble of neutralizing the Omicron variant in triple-vaccinated individ- uals without a history of prior infection, this did not occur at all in those previously infected with the Wuhan strain. The authors remarked that “Immune imprinting by prior Wu- han Hu-1 infection completely abrogated any enhanced nAb [neu- tralizing antibody] responses against B.1.1.529 (Omicron) and other VOC [variants of concern]”. However, what they really meant, logically, is that immune im- printing by prior infection with the ancestral strain followed by three doses of a vaccine designed to imprint immune responses specific to the spike protein of that same strain completely abrogated the antibody re- sponse against other variants. Similarly, they commented that “immune imprinting from prior Wuhan Hu-1 infection resulted in absence of a T cell response” against the S1 domain of the Omicron spike protein, meaning again, of course, that this immune imprinting was the effect of in- fection plus three doses of a vaccine designed imprint immune responses spe- cific to the spike protein of the Wuhan strain. In yet another illustration of cognitive dissonance, the authors curiously blamed the effect of immune imprinting on natural infec- tion by stating, “That previous SARS-CoV-2 infection history can imprint such a profound, negative impact on subsequent protective immunity is an unexpected consequence of COVID-19.”122 Shockingly, although it has been understood for over half a cen- tury that the detrimental effect of original antigenic sin is The Absence of Evidence for Vaccine Efficacy 77 exacerbated by “repeated stimulation” with the same antigen,123 the authors of the Science paper appear to have completely dismissed the possibility that it may have been the subsequent three-dose vac- cination of these individuals that resulted in this intense immuno- logic fixation on the spike protein of a strain of SARS-CoV-2 that has long since disappeared. Their implicit claim that three doses of vaccine did not exacer- bate the problem of original antigenic sin in those with a history of prior infection with the ancestral strain is unsupportable by their data, which did not include a comparison of the immune responses of unvaccinated individuals originally infected with the Wuhan strain and then reinfected with Omicron.124 Given the results of other studies showing the greater adapta- bility of natural immunity, we can anticipate that, had they done such a comparison, the results would have been most unfavorable for the vaccinated. The repeated confirmations in the medical literature that origi- nal antigenic sin does occur with COVID-19 vaccines is a plausible explanation for repeated observations of significantly negative vac- cine effectiveness. Yet the FDA completely ignored the repeated findings in the literature of negative effectiveness, and it completely ignored the numerous confirmations of a detrimental effect of vac- cination on the immune system. The FDA completely failed to consider the superior immunity induced by infection as an opportunity cost of vaccination, and this failure falsifies its claim to have conducted a “rigorous”, “thorough”, and “comprehensive” risk-benefit analysis. Additionally, despite the CDC’s own data indicating that 75 per- cent of children aged six months to four years already had evidence of natural immunity as of February 2022, again, the FDA fraudu- lently conducted its risk-benefit analysis as though all children in the US were immunologically naïve. The Absence of Evidence for Vaccine Efficacy 78 As already noted, the FDA’s immunobridging analysis excluded children with a history of prior infection, and while previously in- fected children were not excluded from the overall trial population, the FDA’s “efficacy analyses do not include cases in previously in- fected participants”. The FDA acknowledges that one limitation of its risk-benefit analysis is that it remains unknown whether vaccination will confer a benefit outweighing the risks to children aged six months to four years who have already acquired natural immunity.125 The FDA further acknowledges that trial safety data in children previously infected with SARS-CoV-2 are “limited”, which, as we’ve already seen, is a term used euphemistically by the FDA to mean that the data do not enable scientists to have any confidence that the shots will confer a benefit outweighing the risks to these children.126 In sum, the FDA utterly failed to produce data demonstrating that three doses of Pfizer’s mRNA COVID-19 vaccine will confer a benefit to naturally immune children that outweighs the risks. The FDA knows that its ostensible risk-benefit analysis is simply inap- plicable to the vast majority of children in the US, and yet it went ahead and fraudulently generalized its analysis to the entire child- hood population anyway. Likewise, the FDA utterly failed to produce data demonstrating that vaccination will confer a benefit even to previously unexposed children that would outweigh the risks, which include a detrimental imprinting of the immune response to fixate suboptimally on the spike protein of an extinct variant at the opportunity cost of more durable and adaptive natural immunity.127 In sum, the scientific evidence supports the conclusion that by authorizing this vaccine for “emergency use” and recommending it for infants and toddlers, the federal government is responsible for The Absence of Evidence for Vaccine Efficacy 79 making children more vulnerable to COVID-19 throughout their life- times. 80 he trial safety population for participants aged six to twenty- three months totaled 1,776, with 1,178 in the vaccine group and 598 in the placebo group. For those aged two to four years, the total was 2,750, with 1,835 in the vaccine group and 915 in the placebo group. Thus, the trial was powered to detect only fairly common ad- verse events and would be unlikely to detect serious adverse events that might occur more rarely, such as one in every three-thousand vaccinated children. For the older age group, the FDA reported that the rate of se- rious adverse events was higher in the placebo group than the vac- cine group: eight events, or 0.9 percent, compared to twelve events, or 0.7 percent, respectively. Since the placebo was reportedly inert saline, this likely represents the lack of statistical significance of the data, an outcome of random chance. Among the younger children, the FDA reported that 3.1 per- cent of those vaccinated experienced a severe adverse event com- pared to 2.3 percent of those in the placebo group. This might also reflect mere random chance, but the FDA was unreasonably dis- missive of this higher rate of serious adverse events among vaccine recipients. None were “considered by the study investigator or by FDA to be related to vaccination” because most “were gastrointes- tinal or respiratory illnesses/infections that occur commonly in this age group.”128 T Ignoring Possible “Non-Specific Effects” of COVID 19 Vaccines 81 The FDA thus demonstrated willful ignorance of a body of lit- erature on what are called “non-specific effects” of vaccines. This refers to unintended consequences that may be beneficial or detri- mental, and which are distinguished from the types of acute ad- verse events that are anticipated to occur due to vaccination. Whereas an adverse event like fever is easily attributable to vaccina- tion given the temporal relationship between the two, non-specific effects may not be observable in the data until years later. As explained in a Nature article by leading researchers in the field, “vaccines can also have non-specific effects on unrelated in- fections and diseases, with important implications for childhood mortality”. As an example of a detrimental non-specific effect, they noted how studies had shown that “non-live vaccines (such as DTP [diph- theria, tetanus, and whole-cell pertussis], the pentavalent vaccine for DTP, hepatitis B virus (HBV) and Haemophilus influenzae type b [Hib], inactivated polio vaccine, single HBV vaccine, the RTS,S/AS01 malaria vaccine, and the H1N1 influenza vaccine) seem to increase susceptibility to vaccine-unrelated infections, particularly in fe- males.”129 (Emphasis added.) As top researchers in the field remarked in a study of the non- specific effects of the DTP vaccine published in the Lancet journal EBioMedicine in 2017: It should be of concern that the effect of routine vac- cination on all-cause mortality was not tested in ran- domized trials. All currently available evidence sug- gests that DTP vaccine may kill more children from other causes than it saves from diphtheria, tetanus, or pertussis. Though a vaccine protects children against the target disease it may simultaneously increase sus- ceptibility to unrelated infections.130 Ignoring Possible “Non-Specific Effects” of COVID 19 Vaccines 82 Likewise, it should be of concern that the effect of COVID-19 vaccination on broader health outcomes, including all-cause mor- tality, was not tested in clinical trials. The FDA is also wrong to dismiss severe adverse events in the vaccine group as unrelated to the vaccine when it is known that vaccination can impact immunity to diseases other than the specific disease the vaccine is designed to prevent. Importantly, as also noted by leading researchers into the “non- specific effects” of vaccines, the clinical trials for mRNA COVID-19 vaccines have shown no mortality benefit of vaccina- tion, which is to say that they have not been shown to reduce the risk of death. This is explainable because, once again, while vac- cines might offer protection against dying from the target disease, they can simultaneously increase the risk of death from other causes.131 For instance, the data from Pfizer’s clinical trial for participants aged sixteen years or older through six-months of follow up showed that 0.07 percent of participants in the vaccine group died compared to 0.06 percent of those in the placebo group. While two people died from COVID-19 in the placebo group compared to one in the vaccine group, the most notable disparity is that four people in the vaccine group died of a heart attack compared to one in the placebo group.132 While we don’t know that these deaths were caused by the vac- cine since the trial wasn’t powered to answer that question, the fact that more people died in the vaccine group is certainly a cause for concern. Relatedly, the authors of a study published in Food and Chemical Toxicology on April 15, 2022, noted that “the immune response to the vaccine is very different from that to a SARS-CoV-2 infection”, and they presented evidence “that vaccination induces a profound Ignoring Possible “Non-Specific Effects” of COVID 19 Vaccines 83 impairment in type I interferon signaling, which has diverse adverse consequences to human health.” This impairment of innate immunity “could lead to increased susceptibility to COVID-19 in the two weeks following the first vaccine, before an antibody response has been initiated.” Further- more, “If the impairment by the vaccine is maintained as antibody levels wane over time, this could lead to a situation where the vac- cine causes a more severe disease expression than would have been the case in the absence of the vaccine.” Alluding to the possibility of detrimental non-specific effects of COVID-19 vaccination, they remarked that the “extensively docu- mented subversion of innate immunity”, or immune “suppres- sion”, would have “a wide range of consequences, not the least of which include the reactivation of latent viral infections and the re- duced ability to effectively combat future infections.”133 In sum, Pfizer’s clinical trial data show no significant protection in infants and toddlers from three doses of its COVID-19 vaccine against symptomatic infection, much less against severe disease or death; the trial was not powered to be able to meaningfully compare the rate of serious adverse events between vaccine and placebo groups; and the FDA illustrated willful ignorance of the literature on “non-specific effects” by dismissing the possibility that vaccina- tion might increase children’s risk of other infections. Finally, we could stipulate that the vaccine is relatively safe for young children in terms of the rate of acute adverse events, and it would certainly not follow that the risks are outweighed by the ben- efits since the clinical trial data fail to demonstrate a benefit, since observational data have indicated waning to significantly negative effectiveness, and since mechanistic studies have confirmed that original antigenic sin is a real problem with vaccination. 84 n the absence of large, randomized, placebo-controlled trials comparing long-term health outcomes, including all-cause mortality, between vaccinated and unvaccinated individuals, any claim that a vaccine is “safe” and “effective” is scientifically meaningless. The FDA has acted to ensure that we never have such data for COVID-19 vaccines. In fact, as already mentioned, there has already been unblinding of the clinical trial for children under five, with the placebo group largely having been vaccinated away. Six months after receipt of their second dose, trial participants assigned to the placebo group prior to the change of protocol add- ing the third dose were unblinded and offered the vaccine. Partici- pants enrolled after the protocol change “will be unblinded at their 6-month post-Dose 3 visit,” the decision memorandum states, “and those originally randomized to placebo will be offer ed BNT162b2 vaccination.”134 (BNT162b2 is the technical name of the Pfizer-BioNTech COVID-19 vaccine.) The first unblinding occurred on September 28, 2021, and vac- cination of participants in the placebo group commenced on No- vember 3, 2021. A third dose was first administered on January 31, 2022, and the protocol amendment adding the third dose to the primary series was implemented on February 1, 2022. So, I Ensuring that COVID 19 Vaccines Will Never Be Properly Assessed 85 vaccination of what’s left of the placebo group recommenced in August 2022. Vaccinating away the placebo group resulted in a median dura- tion of blinded follow-up of just 1.3 months for the younger safety population and 1.4 months for the older safety population. The maximum duration of follow-up for both populations was 3.2 months. Of the 598 original placebo-group participants in the safety population for children aged six to twenty-three months, 377 (63 percent) were unblinded, and of those, 344 (91.2 percent) were already vaccinated by the time the FDA conducted its review. Thus, 58 percent of the original placebo group had already been vac- cinated away. Of the 915 original placebo-group participants in the safety population for children aged two to four years, 424 (46.3 percent) were unblinded, and of those, 370 (87.3 percent) were vaccinated. Thus, 40 percent of the original placebo group was already vac- cinated away prior to the FDA’s issuance of emergency use author- ization.135 By allowing Pfizer to vaccinate away the placebo group, the FDA has ensured that scientists will never have clinical trial data from which to compare long-term health outcomes between vac- cinated and unvaccinated children. 86 s already discussed, the FDA fully anticipates that infants and toddlers receiving three doses of Pfizer’s COVID-19 vaccine will require booster shots. However, “public health” officials and policymakers are already confronted with a lack of demand for these risk-carrying pharmaceutical products. There is widespread awareness among the public that these vac- cines are highly ineffective against the circulating Omicron subvari- ants, and people understandably do not see the point of getting a booster dose of a vaccine that was not designed to protect against Omicron.136 Therefore, the government has been pushing for a new genera- tion of COVID-19 booster shots redesigned to cause the cells to produce the spike protein of Omicron subvariants, with the aim being to rush the new products to market without first being tested in new clinical trials. On November 29, 2021, President Biden announced that he was directing the FDA and CDC to use “the fastest process availa- ble” to authorize new vaccines “without cutting any corners for safety”.137 As the Wall Street Journal reported on December 3, 2021, the FDA had begun “laying the groundwork for the rapid review of Omicron-targeted vaccines”. The FDA’s intent for the “expedited A Ensuring that Omicron-Based Booster Shots Won’t Be Tested in Clinical Trials 87 review process” was for the new vaccines to not be evaluated for safety and efficacy in randomized controlled trials.138 Instead, the FDA would rely on evaluation of the immune re- sponses to the new products, just as it relied on its fraudulent im- munobridging analysis as the primary basis for authorizing Pfizer’s current product for use in children as young as six months. Thus, the government is preposterously asserting that skipping safety studies entirely is somehow not cutting corners for safety, which serves as yet another remarkable illustration of the institutionalized cognitive dissonance surrounding public vaccine policy. As reported by researcher Toby Rogers on May 31, 2022, the FDA had schemed to establish a “Future Framework” for pushing through new COVID-19 vaccines without requiring the manufactur- ers to conduct clinical trials demonstrating safety and efficacy. As Rogers explained: The purpose of the “Future Framework” is to rig the COVID-19 vaccine regulatory process in perpetuity in favor of the pharmaceutical industry. If this “Fu- ture Framework” is approved, all future COVID-19 shots—regardless of the formulation—will automat- ically be deemed “safe and effective” without addi- tional clinical trials, because they are considered “bio- logically similar” to existing shots. If you change a single molecule of the mRNA in these shots it will change health outcomes in ways that no one can anticipate. That necessarily requires new clinical trials—which is what the FDA is proposing to skip. The FDA’s “expert advisory committee” (VRBPAC) met on April 6, 2022 to discuss the “Future Ensuring that Omicron-Based Booster Shots Won’t Be Tested in Clinical Trials 88 Framework” for the first time. All of the committee members agreed that COVID-19 shots are not work- ing, that boosting multiple times a year was not feasi- ble, and that the shots need to be reformulated. They also unanimously agreed that there are no “correlates of protection” that one can use to predict what anti- body levels would be sufficient to prevent SARS-CoV-2 infection.139 As reported by the New York Times, the FDA’s vaccine advisory committee on June 28 recommended by a nineteen-to-two vote that the FDA “move to updated coronavirus booster shots target- ing some form of the Omicron variant that has dominated for months”, which “paves the way for the FDA to push manufacturers to make reformulated boosters in time for the Biden administration to offer them later this year, before an expected winter surge of the virus.” Both Pfizer and Moderna had already been working on new vac- cines to target Omicron, but Omicron had already been “squeezed out by subvariants” almost three months prior, “and regulators said in briefing materials that a booster targeting it would be ‘already somewhat outdated.’” Some on the advisory committee favored a formulation targeting the predominant BA.4 and BA.5 subvari- ants.140 A day after that vote, the US Department of Health and Human Services (HHS), which is the parent agency of both the FDA and CDC, announced that the Biden administration had signed a $3.2 billion contract with Pfizer to purchase 105 million booster doses of a COVID-19 vaccine formulated to target Omicron for a fall vaccination campaign, with an option to purchase as many as 300 million doses.141 Ensuring that Omicron-Based Booster Shots Won’t Be Tested in Clinical Trials 89 As the New York Times observed, the government was “betting on a next generation of boosters without knowing who might need one or how they will perform.”142 The day after the contract was announced, the FDA issued a statement from Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, acknowledging the ineffec- tiveness of three doses of COVID-19 vaccine against Omicron and announcing that the FDA had advised manufacturers to develop new booster shots containing both the original formulation and Omicron BA.4 and BA.5 components. “As we move into the fall and winter,” Marks said, “it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19.” Marks further declared, “The American public can be assured that any COVID-19 vaccine authorized or approved by the FDA meets our standards for safety and effectiveness.” The statement informed that the vaccine manufacturers “will also be asked to begin clinical trials with modified vaccines contain- ing an omicron BA.4/5 component”. However, the FDA notably did not indicate that clinical trials would be required for the new vac- cines to obtain authorization. Instead, the FDA remarked that data from new trials would merely be “of use as the pandemic further evolves.”143 However, as the case study of its authorization of Pfizer’s vac- cine for infants and toddlers clearly demonstrates, it is not just that the FDA’s standards are horrifically low, but the FDA has a demon- strated willingness to perpetrate outright scientific fraud in service to the pharmaceutical industry and clueless politicians. Even if new trials were required, we could easily anticipate that the FDA will only pretend to conduct a serious scientific analysis, once again masquerading its scientific fraud as a “rigorous”, Ensuring that Omicron-Based Booster Shots Won’t Be Tested in Clinical Trials 90 “comprehensive”, and “thorough” evaluation of the safety and ef- fectiveness of the new shots. But the FDA will not even pretend to do that science for refor- mulated vaccines. As the FDA subsequently clarified, new clinical trials would not be required for the new vaccines to receive author- ization. As reported by Reuters on June 30, 2022: The US Food and Drug Administration will not re- quire companies to submit clinical trial data on COVID-19 vaccines modified to protect against the BA.4 and BA.5 versions of Omicron in order to au- thorize those shots, a top FDA official said on Thurs- day. Dr. Peter Marks, head of the agency’s Center for Bio- logics Evaluation and Research, told Reuters the agency will rely on data from clinical trials vaccine makers have run on shots designed to combat the BA.1 lineage, as well as manufacturing data, for emer- gency use authorization submissions before the fall.144 Thus, we can see that it is the FDA transparently intends to per- petrate still more scientific fraud for the purpose of pushing through authorization of Omicron-targeting booster shots. 91 eporting on these developments, the New York Times noted that Pfizer and Moderna had already been working on vac- cines targeting Omicron, and both claimed that their devel- opmental products “induced higher levels of antibodies against the variant than the existing vaccines, but with a modest increase.” At the very end of the Times article came an acknowledgment that “the decision to update the booster to address BA.4 and BA.5 without robust data could in part be attributed t o pressures the Biden administration may face to appear prepared for another wave of virus cases.”145 One of the minority members of the FDA’s advisory committee who voted against the recommendation to add an Omicron compo- nent to fall COVID-19 booster shots was Dr. Paul Offit, who co- authored an article in STAT on June 29, 2022, titled, “FDA: Don’t rush a move to change the Covid-19 vaccine composition”.146 In one interview, Offit described the committee’s meeting as “unusual” and “upsetting”. Explaining his nay vote, Offit said, “I just didn’t see the bene- fits.” He was surprised that nineteen out of twenty-one voting members of VRBPAC voted in favor because he “just didn’t see the evidence for that.” As explanation, he suggested that “this was something that was desired by the Biden administration”. What Offit found unusual was that, normally, the committee is just presented with the data so that they can offer their advice, which the FDA was free to accept or ignore. This time, however, R Government Vaccine Policy Versus Science 92 an official from the World Health Organization (WHO) and an FDA official appeared to prejudice the outcome by both first pre- senting their opinions that this recommendation should be made. “Then the next day”, Offit continued, “you read a press release from the HHS that says the government has decided to purchase at least 105 million doses from Pfizer with up to 300 million doses.” Those circumstances led Offit to the conclusion that “the fix was in a little bit”. The data presented by both Moderna and Pfizer on their devel- opmental vaccine targeting Omicron, Offit said, “was not compel- ling.” He relayed that their data indicated that there was “a 1.75-fold increase in neutralizing antibodies against Omicron”. Offit contin- ued (emphasis added): Well, the question is, what does that mean? What does that number mean, and the answer is I think while sta- tistically significant, I don’t think that’s a clinically signifi- cant difference. The reason I say that is because if you look at the original vaccines when they were author- ized back in mid-December 2020, there was a two- fold difference between Moderna and Pfizer regard- ing neutralizing antibodies. Moderna had a two-fold in- crease in neutralizing antibodies, but it did not translate into a clinically significant difference in terms of protection against se- vere disease, which is the goal of this vaccine. The host of the interview, Dr. Zubin Damania, who goes by “ZDoggMD” and has described himself as “arguably the biggest advocate for vaccination on social media”, conceded that “it seems like the burden of proof for FDA seems to be going down and down and down instead of being at a level that you’re comfortable with.”147 Government Vaccine Policy Versus Science 93 As Offit further explained to JAMA, “It is not reasonable to assume that data generated for an Omicron BA.1 vaccine can easily be extrapolated to BA.4 and BA.5.” Also, the available data from the manufacturers on their devel- opmental BA.1 vaccines showed only a modest increase in neutral- izing antibodies. “Why would we think using BA.4 or BA.5 would be any different?” he rhetorically inquired, pointing out once again that the increased antibody titers weren’t necessarily clinically sig- nificant. The other dissenting member of the FDA’s advisory committee, Dr. Henry Bernstein, told JAMA, “There was no compelling evi- dence that adding the new element to the vaccine was going to in- crease vaccine effectiveness.”148 A critical unanswered question the FDA appears uninterested in learning the answer to is whether any increase in neutralizing anti- bodies from booster shots containing Omicron components would represent antibodies specific to Omicron or whether the antibodies remain specific to the Wuhan strain and merely happen to cross- react with the spike protein of Omicron. Given what scientists already know about original antigenic sin, we can anticipate that modified booster vaccines will not actually do anything to broaden immune responses to be more specific to any of the Omicron subvariants. Mainstream media have generally reported on the FDA’s author- ization uncritically, as though the supposed “regulatory” agency had done its due diligence to conduct a rigorous and thorough risk- benefit analysis. The New York Times, for example, lauded the au- thorization as “a relief to parents who have waited 18 months to protect their babies, toddlers and preschoolers since shots first be- came available.”149 The Wall Street Journal, by contrast, ran a sensible commentary by editorial board member Allysia Finley pointing out the low Government Vaccine Policy Versus Science 94 standards used by the FDA as the basis for its authorization. The headline asked, “Why the Rush for Toddler Vaccines?” Upon authorization, President Biden declared that “The United States is now the first country in the world to offer safe and effec- tive COVID-19 vaccines for children as young as 6 months old.” But as Finley correctly pointed out: In fact, we don’t know if the vaccines are safe and effective. The rushed FDA action was based on ex- tremely weak evidence. It’s one thing to show regula- tory flexibility during an emergency. But for children, Covid isn’t an emergency. The FDA bent its standards to an unusual degree and brushed aside troubling ev- idence that warrants more investigation. Finley rightly took issue with the fact that “the FDA authorized the vaccines for toddlers based on a comparison of the antibodies they generated to the original Wuhan variant”, which it did despite having knowledge that the vaccine offers “little if any protection against Omicron”. Additionally: Pfizer claimed its vaccine was 80% effective, but this is misleading. For one, Pfizer contravened numerous clinical-trial conventions. Its initial protocol involved only two doses, but this failed to generate the a nti- body levels required for FDA approval [sic]. Usually the agency won’t let drugmakers make a course cor- rection when a trial ends in failure. Pfizer then planned to track at least 21 cases to estab- lish a bare-bones measure of efficacy. By comparison, Moderna tracked more than 250 cases. Yet Pfizer truncated its data collection on April 29—the day Government Vaccine Policy Versus Science 95 after Moderna announced it had submitted its appli- cation for emergency-use authorization—even though a mere 10 cases had been recorded after the third dose. It’s hard not to conclude that Pfizer cut corners to avoid getting beaten by Moderna. But as a result too few cases were documented to measure with any degree of confidence Pfizer’s vaccine effi- cacy. Pfizer nonetheless proclaimed its vaccine was 80% effective. Tellingly, a Pfizer spokesperson said that “the FDA was more interested in vaccine ‘immunogenicity’ data than efficacy”. “More troubling,” Finley continued, “vaccinated toddlers in Pfizer’s trial were more likely to get severely ill with Covid than those who received a placebo. . . . Also worrisome: Most kids who developed multiple infections during the trial were vaccinated. This warranted more investigation, since experimental vaccines for other diseases sometimes increase susceptibility to infection.” Astonishingly for a mainstream media outlet, in addition to ac- knowledging the possibility of non-specific effects of vaccination, the Wall Street Journal commentary even acknowledged studies showing that original antigenic sin is a problem with these vaccines, stating that “immunological imprinting” was a possible explanation for “why children who received three Pfizer shots were more likely to get reinfected.” The FDA nevertheless “brushed aside the risk that inoculating infants against a variant no longer circulating could blunt their im- mune responses to Omicron and its offshoots.” In sum, the FDA “conspicuously lowered its standards to ap- prove Covid vaccines for toddlers.” The question was “Why?” The answer proposed by Finley was political pressure from the White House.150 Government Vaccine Policy Versus Science 96 It was an unusually honest commentary that contrasts with the mainstream media’s general tendency to try to sustain the illusion that the FDA had conducted a “rigorous”, “comprehensive”, and “thorough” risk-benefit analysis. Another unusually honest commentary appeared in Newsweek a week prior to the FDA’s authorization of Pfizer’s vaccine for use in children as young as six months, which article ran under the overly optimistic headline “Why America Doesn’t Trust the CDC”. (Too many Americans unfortunately still do place their faith in this agency despite its consistently demonstrated untrustworthiness.) The author, Dr. Marty Makary, a professor at the Johns Hopkins School Medicine, excoriated the CDC for effectively using the childhood population as subjects of a mass uncontrolled experi- ment. His article opened: Pe ople don’t trust the CDC. Here’s one example illus- trating why. Two weeks ago, with no outcomes data on COVID-19 booster shots for 5-to-11-year-olds, the Centers for Disease Control (CDC) vigorously recommended the booster for all 24 million American children in that age group. The CDC cited a small Pfizer study of 140 children that showed boosters el- evated their antibody levels—an outcome known to be transitory. When that study concluded, a Pfizer spokesperson said it did not determine the efficacy of the booster in the 5-to-11-year-olds. But that didn’t matter to the CDC. Seemingly hoping for a different answer, the agency put the matter before its own kangaroo court of curated experts, the Advisory Committee on Im- munization Practices (ACIP). Government Vaccine Policy Versus Science 97 I listened to the meeting and couldn’t believe what I heard. At times, the committee members sounded like a group of marketing executives. In lieu of a sound medical rationale for recommending the booster shot for young children, committee members seemed more interested in maintaining consistent public relations messaging. Members expressed the concern that to not recommend booster shots for kids would “create confusion” that might result in adoles- cents and adults questioning the utility of a booster dose. One member, Dr. Oliver Brooks, argued that the CDC recom- mend that younger children “should” get the booster shot rather than saying that they “may” get it. His reasoning was that “may is confusing and may sow doubt”, whereas “if we say should, more people will get boosted versus may, then we may have more data that helps us define where we’re going.” Hence, as Makary astutely observed, “Dr. Brooks was essentially suggesting that boosting in this age group would be a clinical trial conducted without informed consent. That doesn’t sound like fol- lowing the science to me.” The one dissenting vote in the meeting came from Dr. Keipp Talbot of Vanderbilt University, who noted that vaccination is not without risk, and who “questioned the sustainability of vaccinating the population every six months.” “Most remarkably,” Makary added, “it didn’t seem to matter to the CDC that 75.2 percent of children under age 11 already have natural immunity, according to a CDC study that concluded in Feb- ruary.” The CDC ignored this evidence despite its own data having “demonstrated that natural immunity was 2.8 times more effective in preventing hospitalization and 3.3 to 4.7 times more effective in Government Vaccine Policy Versus Science 98 preventing COVID infection compared to vaccination during the Delta wave.” Those findings were consistent with many other studies, “Yet natural immunity has consistently and inexplicably been dismissed by the medical establishment.” The result was that the CDC was “pushing boosters on healthy children who are already immune”. The FDA, for its part, had for the third time in a year “made sweeping and controversial authorizations without convening its vaccine experts.” In authorizing booster doses for children aged five to eleven, the FDA had bypassed VRBPAC. Makary concluded, “The Biden administration promised to lis- ten to the scientists. But the truth is, it only seems to listen to the ones who say what it wants to hear.”151 After the FDA’s authorization of Pfizer’s vaccine for infants as young as six months, Dr. Makary and Dr. Tracy Beth Høeg, a con- sultant epidemiologist with the Florida Department of Health, wrote an article titled “U.S. Public Health Agencies Aren’t ‘Follow- ing the Science,’ Officials Say”. In it, they described how top doc- tors and scientists in the National Institutes of Health (NIH), FDA, and CDC were reaching out to express frustration and exasperation about these agencies’ unscientific approach to policymaking. The officials agreed to be quoted only anonymously out of “fear of professional repercussions.” “It’s like a horror movie I’m being forced to watch and I can’t close my eyes,” one senior FDA official told them. “People are get- ting bad advice and we can’t say anything.” The official was refer- ring to how the FDA had bypassed its advisory committee to au- thorize booster shots for children aged five to eleven years and au- thorized COVID-19 vaccines for infants and toddlers in the ab- sence of solid clinical data. A “high level official at the CDC” put the rhetorical question to them: “Things have become so political, so what are we there for?” Government Vaccine Policy Versus Science 99 Another CDC scientist said, “I used to be proud to tell people I work at the CDC. Now I’m embarrassed.” The reason for such discontentment within these “public health” agencies, Makary explained, was that “the heads of their agencies are using weak or flawed data to make critically important public health decisions. That such decisions are being driven by what’s politically palatable to people in Washington or to the Biden administration. And that they have a myopic focus on one virus instead of overall health.” Examples of this institutional myopia include demanding that young children be masked in schools, a policy that studies had found to make no difference in rates of transmission while hinder- ing children’s social and linguistic development, for which they need to see the faces of others. The agencies were also “catastrophically” wrong to close schools. One CDC scientists conceded: CDC failed to balance the risks of Covid with other risks that come from closing schools. . . . Learning loss, mental health exacerbations were obvious early on and those worsened as the guidance insisted on keeping schools virtual. CDC guidance worsened ra- cial equity for generations to come. It failed this gen- eration of children. “Then they ignored natural immunity”, Makary continued. “Wrong again.”152 (Indeed, prior to its own researchers publishing data falsifying the claim, the CDC had been lying to the public that the vaccines offered better protection than natural immunity.153) One FDA official told them, “I can’t tell you how many people at the FDA have told me, ‘I don’t like any of this, but I just need to make it to my retirement.” Government Vaccine Policy Versus Science 100 Referring to the absence of clinical trial data from Pfizer demonstrating efficacy in young children, a “high-level CDC offi- cial” joked, “You can inject them with it or squirt it in their face, and you’ll get the same benefit.” (Moderna’s results “were not much better”, the authors remarked.) A CDC physician told them, “It seems criminal that we put out the recommendation to give mRNA Covid vaccines to babies with- out good data. We really don’t know what the risks are yet. So why push it so hard?” A “high-level FDA official” similarly lamented, “The public has no idea how bad this data really is. It would not pass muster for any other authorization.” One CDC scientist related having been discriminated against for not receiving a booster shot. The individual was unable to go on a trip with a group of parents due to a requirement that everyone show proof of having received the booster dose. “I asked for someone to show me the data,” the CDC scientist related. “They said the policy was based on the CDC recommendation.” An NIH scientists explained, “There’s a silence, an unwilling- ness for agency scientists to say anything. Even though they know that some of what’s being said out of the agency is absurd.” An FDA staffer similarly explained, “You get labeled based on what you say. If you talk about it you will suffer, I’m convinced. Another person from the FDA said, “If you speak honestly, you get treated differently.”154 This culture of corruption and dishonesty within the so-called “public health” establishment helps to explain the unbridgeable gap between public vaccine policy and the science. 101 nce the FDA had authorized COVID-19 vaccines for in- fants and toddlers, the CDC rushed to recommend the shots universally for this age group. CDC Director Ro- chelle Walensky enthusiastically issued this public statement (em- phasis added): COVID-19 vaccines are now available for children under five. With this recent authorization from FDA and recommendation from CDC, nearly 20 million children are now able to get vaccinated against COVID-19. I know many parents with very young children have been anticipating this day. We now know, based on rigorous scientific review, that the vaccines available here in the United States can be used safely and effectively in children under five. Vaccinating young chil- dren is a critical opportunity to protect them against hos- pitalization and death from COVID-19.155 Walensky’s claims illustrate the extent to which “public health” officials are willing to blatantly lie to parents in order to persuade them to vaccinate their children. Once again, the characterization of the FDA’s review as “rigor- ous” is demonstrably false. It was the opposite of rigorous, charac- terized instead by sloppy research, logical fallacies, factual errors, and willful deception. Furthermore, Walensky’s implicit claim that the data reviewed by the FDA showed that the vaccines are effective at preventing O Conclusion 102 hospitalization and death is a bald-faced lie. While an examination of the FDA’s decision memorandum for its authorization of Moderna’s product is beyond the scope of this paper (which is lengthy enough just detailing the scientific fraud underlying the au- thorization of Pfizer’s product), with respect to Pfizer’s vaccine, there was a notable absence of data demonstrating efficacy in pre- venting symptomatic infection, much less in preventing hospitali- zation and death (and Moderna’s clinical trial was also not designed to determine effectiveness against hospitalization and death). The CDC Director cannot be unaware that by conveying the message that the clinical trial data showed that the vacc ines can be “safely and effectively” used in children under five to prevent hos- pitalization and death from COVID-19, she is deceiving parents into getting their kids vaccinated. The good news is that there is a growing awareness of just how anti-science the “public health” establishment really is, and how de- cisions are made with reckless disregard for people’s wellbeing, in- cluding callous disregard for the health of children. While the mainstream media continue to decry parents’ “hesi- tancy” to get their children COVID-19 vaccines as though this was worrisome, we should rather be encouraged that so many parents today are doing their own research, thinking for themselves, and trusting their own judgment rather than placing blind faith in the recommendations of government agencies that have repeatedly proven their willingness to lie to the public in furtherance of their policy goal of achieving high vaccine uptake.156 By authorizing Pfizer’s vaccine on scientifically fraudulent grounds, the FDA has revealed its true colors unmistakably for even the most hardened advocates of public vaccine policy, thus proving what many of us have been saying since long before the COVID-19 pandemic, which is that government “health” officials are completely unworthy of our trust and are willing to place our Conclusion 103 children’s health and lives at risk in furtherance of their own agenda, which is to serve the financial interests of the pharmaceu- tical industry at the expense of public health. 104 1 Food and Drug Administration, “Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age”, Press Release, FDA.gov, June 17, 2002, https://www.fda.gov/news-events/press-announce- ments/coronavirus-covid-19-update-fda-authorizes-moderna- and-pfizer-biontech-covid-19-vaccines-children. My analysis focuses only on the Pfizer-BioNTech vaccine because I have reviewed the FDA’s decision memorandum for this product but not yet for Moderna’s. 2 Food and Drug Administration, Letter of Authorization to Pfizer, FDA.gov, June 17, 2022, https://www.fda.gov/me- dia/150386/download. 3 This is known formally as the petitio principii fallacy, also known as circular reasoning or begging the question. 4 Food and Drug Administration, “Emergency Use Authoriza- tion (EUA) for an Unapproved Product Review Memoran- dum”, FDA.gov, June 17, 2022, p. 8, https://www.fda.gov/me- dia/159393/download. (Hereafter “FDA, ‘Decision Memoran- dum’”.) 5 World Health Organization, “Preliminary Report for the Scien- tific Advisory Group for the Origins of Novel Pathog ens (SAGO)”, WHO.int, June 9, 2022, https://www.who.int/publi- cations/m/item/scientific-advisory-group-on-the-origins-of- novel-pathogens-report. Yujia Alina Chan and Shing Hei Zhan, “The Emergence of the Spike Furin Cleavage Site in Notes 105 SARS-CoV-2”, Molecular Biology and Evolution, November 12, 2021, https://doi.org/10.1093/molbev/msab327. Jacques van Helden et al., “An appeal for an objective, open, and transpar- ent scientific debate about the origin of SARS-CoV-2”, The Lancet, September 17, 2021, https://doi.org/10.1016/S0140- 6736(21)02019-5. US House of Representatives, Letter from James Comer and Jim Jordan to the Secretary of the US De- partment of Health and Human Services, January 11, 2022, https://republicans-oversight.house.gov/wp-content/up- loads/2022/01/Letter-Re.-Feb-1-Emails-011122.pdf. 6 FDA, “Decision Memorandum”, p. 8. 7 Elisha Fieldstadt, “Fauci says drop in Covid cases not due to vaccine: ‘We don't want to get complacent’”, NBC News, June 25, 2021, https://www.nbcnews.com/news/us-news/fauci- says-drop-covid-cases-not-due-vaccine-we-don-n1255505. 8 Centers for Disease Control and Prevention, “Trends in Num- ber of COVID-19 Cases and Deaths in the US Reported to CDC, by State/Territory”, CDC.gov, accessed June 28, 2022, https://covid.cdc.gov/covid-data-tracker/#trends_dailycases. Centers for Disease Control and Prevention, “Trends in Num- ber of COVID-19 Vaccinations in the US”, CDC.gov, accessed June 28, 2022, https://covid.cdc.gov/covid-data- tracker/#vaccination-trends. To illustrate, for the screenshots, I have selected January 16, at which time the trend of falling cases was already underway. 9 Catherine M. Brown et al., “Outbreak of SARS-CoV-2 Infec- tions, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021”, MMWR, July 30, 2021, http://dx.doi.org/10.15585/mmwr.mm7031e2. Michael Nedelman, “CDC shares 'pivotal discovery' on Covid-19 breakthrough infections that led to new mask guidance”, Notes 106 CNN, July 30, 2021, https://www.cnn.com/2021/07/30/health/breakthrough-in- fection-masks-cdc-provincetown-study/index.html. Madeline Holcombe and Christina Maxouris, “Fully vaccinated people who get a Covid-19 breakthrough infection can transmit the virus, CDC chief says”, CNN, August 6, 2021, https://www.cnn.com/2021/08/05/health/us-coronavirus- thursday/index.html. CDC Director Rochelle Walensky admit- ted that “public health” officials’ declarations that the vaccines would end the pandemic by inducing durable sterilizing im- munity were based on hope not evidence during an interview 10 For extensive documentation of how “public health” officials perpetually lied about natural immunity versus vaccine-induced immunity, see my series of articles compiled at: https://www.jeremyrhammond.com/natural-immunity-to- sars-cov-2/. See especially: Jeremy R. Hammond, “The CDC Finally Admits That Natural Immunity to SARS-CoV-2 Is Su- perior to the Immunity Induced by COVID-19 Vaccines”, Jere- myRHammond.com, February 10, 2022, https://www.jere- myrhammond.com/2022/02/10/the-cdc-finally-admits-that- natural-immunity-to-sars-cov-2-is-superior-to-the-immunity- induced-by-covid-19-vaccines/. 11 Washington University School of Medicine, “CDC director Rochelle Walensky visits #WashUMed”, YouTube, March 3, 2022, https://www.youtube.com/watch?v=I_hYgIpxM4A. 12 Rochelle Walensky, “The science is clear”, Twitter, May 17, 2021, https://twitter.com/CDCDirector/sta- tus/1394346871900999697. 13 The Rachel Maddow Show, Transcript, MSNBC, March 29, 2021, https://www.msnbc.com/transcripts/transcript-rachel- maddow-show-3-29-21-n1262442. Notes 107 14 Dr. Deborah Birx, Testimony to the House Oversight and Re- form Subcommittee on Select Coronavirus Crisis, C-SPAN, June 23, 2022, https://www.c-span.org/video/?c5021092/dr- birx-knew-natural-covid-19-reinfections-early-december-2020. 15 Lawrence Smith, “Dr. Deborah Birx applauds Beshear's 'pro- active' handling of the coronavirus”, WDRB, December 15, 2020, https://www.wdrb.com/news/dr-deborah-birx-ap- plauds-beshears-proactive-handling-of-the-coronavirus/arti- cle_72b4f436-3f18-11eb-ac9d-4be187f7f7a6.html. 16 Jonah Kaplan, “White House Task Force's Dr. Birx urges 'vigi- lance' until millions get vaccinated but sees hope for normal summer”, ABC7, December 17, 2020, https://abc7.com/dr- birx-deborah-white-house-coronavirus-covid-19/8854405/. 17 Fox News Staff, “Dr. Deborah Birx says she ‘knew’ COVID vaccines would not ‘protect against infection’”, Fox News, July 22, 2022, https://www.foxnews.com/media/dr-deborah-birx- knew-covid-vaccines-not-protect-against-infection. 18 Food and Drug Administration, “Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 12 Years of Age and Older”, FDA.gov, archived July 16, 2021, https://web.ar- chive.org/web/20210716140737/https://www.fda.gov/me- dia/144414/download. Food and Drug Administration, “Emergency Use Authorization for Vaccines Explained”, FDA.gov, archived November 12, 2021, https://web.ar- chive.org/web/20211112165238/https://www.fda.gov/vac- cines-blood-biologics/vaccines/emergency-use-authorization- vaccines-explained. Food and Drug Administration, “Investi- gational New Drug (IND) Application”, FDA.gov, archived November 12, 2021, https://web.ar- chive.org/web/20211112165405/https://www.fda.gov/drugs Notes 108 /types-applications/investigational-new-drug-ind-application. Peter Doshi, “Covid-19 vaccines: In the rush for regulatory ap- proval, do we need more data?”, The BMJ, May 18, 2021, https://doi.org/10.1136/bmj.n1244. 19 FDA, “Decision Memorandum”, p. 8. 20 FDA, “Decision Memorandum”, p. 9. 21 Centers for Disease Control and Prevention, “Provisional COVID-19 Death Counts by Age in Years”, CDC.gov, accessed June 30, 2022, https://data.cdc.gov/NCHS/Provisional- COVID-19-Death-Counts-by -Age-in-Years-/3apk-4u4f/data. 22 Kristie E.N. Clarke et al., “Seroprevalence of Infection-In- duced SARS-CoV-2 Antibodies — United States, September 2021–February 2022”, MMWR, April 26, 2022, http://dx.doi.org/10.15585/mmwr.mm7117e3. 23 For further discussion and documentation, see: Jeremy R. Hammond, “‘Original Antigenic Sin’ Is a Real Problem with COVID-19 Vaccines”, JeremyRHammond.com, June 22, 2022, https://www.jeremyrhammond.com/2022/06/22/original-an- tigenic-sin-is-a-real-problem-with-covid-19-vaccines/. 24 Clarke et al. 25 FDA, “Decision Memorandum”, p. 64. 26 The Annie E. Casey Foundation, “Child population by age group in the United States”, KidsCount.org, accessed June 30, 2022, https://datacenter.kidscount.org/data/tables/101-child- population-by-age-group. 27 CDC, “Provisional COVID-19 Death Counts”. 28 Marta Bertran et al., “COVID-19 Deaths in Children and Young People: Active Prospective National Surveillance, March 2020 to December 2021, England”, SSRN, June 20, 2022, https://dx.doi.org/10.2139/ssrn.4125501. 29 FDA, “Decision Memorandum”, pp. 22–24. 30 FDA, “Decision Memorandum”, p. 9. 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Rip- perger, “Orthogonal SARS-CoV-2 Serological Assays Enable Surveillance of Low-Prevalence Communities and Reveal Du- rable Humoral Immunity”, Immunity, October 13, 2020, https://doi.org/10.1016/j.immuni.2020.10.004. Mitchell H. Katz, “Neutralizing Antibodies Against SARS-CoV-2—Im- portant Questions, Unclear Answers”, JAMA Internal Medicine, August 18, 2020, https://doi.org/10.1001/jamaintern- med.2020.4624. Carolyn Rydyznski Moderbacher, “Antigen- Specific Adaptive Immunity to SARS-CoV-2 in Acute COVID-19 and Associations with Age and Disease Severity”, September 16, 2020, https://doi.org/10.1016/j.cell.2020.09.038. La Jolla In- stitute for Immunology, “T Cells Take the Lead in Controlling SARS-CoV-2 and Reducing COVID-19 Disease Sever- ity”, LJI.org, September 16, 2020, https://www.lji.org/news- events/news/post/t-cells-take-the-lead-in-controlling-sars- cov-2-and-reducing-covid-19-disease-severity/. Daniel F. Gud- bjartsson et al., “Humoral Immune Response to SARS-CoV-2 in Iceland”, New England Journal of Medicine, October 29, 2020, https://doi.org/10.1056/NEJMoa2026116. Jennifer M. Dan et al., “Immunological memory to SARS-CoV-2 assessed for greater than six months after infection”, bioRxiv, Novem- ber 16, 2020, https://doi.org/10.1101/2020.11.15.383323. Notes 114 71 La Jolla Institute for Immunology, “T Cells Take the Lead”. 72 FDA, “Decision Memorandum”, p. 16. 73 For further discussion of how the FDA has relied on the sci- entifically fraudulent method of using antibody titers as a surro- gate measure of immunity, see: Jeremy R. Hammond, “Paul Of- fit Unwittingly Exposes Scientific Fraud of FDA’s Vaccine Li- censure”, JeremyRHammond.com, July 26, 2019, https://www.jer- emyrhammond.com/2019/07/26/paul-offit-unwittingly-ex- poses-scientific-fraud-of-fdas-vaccine-licensure/. 74 FDA, “Decision Memorandum”, p. 18. 75 FDA, “Decision Memorandum”, p. 12. 76 For references and discussion, see: Jeremy R. Hammond, “An- tibodies Are More Durable with Natural Immunity Than with Vaccination”, JeremyRHammond.com, November 5, 2021, https://www.jeremyrhammond.com/2021/11/05/antibodies- are-more-durable-with-natural-immunity-than-with-vaccina- tion/. 77 Michael Barbaro, “An Interview With Dr. Anthony Fauci”, New York Times, November 12, 2021, https://www.ny- times.com/2021/11/12/podcasts/the-daily/anthony-fauci- vaccine-mandates-booster-shots.html. For further discussion, see: Jeremy R. Hammond, “The CDC Finally Admits That Natural Immunity to SARS-CoV-2 Is Superior to the Immun- ity Induced by COVID-19 Vaccines”, JeremyRHammond.com, February 10, 2022, https://www.jeremyrham- mond.com/2022/02/10/the-cdc-finally-admits-that-natural- immunity-to-sars-cov-2-is-superior-to-the-immunity-induced- by-covid-19-vaccines/. 78 FDA, “Decision Memorandum”, p. 64. 79 Paul Offit, “Covid-19 Boosters—Where from Here?”, New England Journal of Medicine, April 28, 2022, https://doi.org/10.1056/NEJMe2203329. Notes 115 80 Leah Barkoukis, “Should We Be Boosting Our Way Out of Covid? The European Medicines Agency Is Issuing a Warn- ing”, Townhall, January 12, 2022, https://townhall.com/tip- sheet/leahbarkoukis/2022/01/12/repeated-booster-warning- n2601750. 81 Hammond, “‘Original Antigenic Sin’ Is a Real Problem with COVID-19 Vaccines”. Jeremy R. 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Courtney Subramanian and Elizabeth Weise, “Biden administration expected to recom- mend COVID-19 booster shots for Pfizer, Moderna vaccines”, USA Today, August 17, 2021, https://www.usato- day.com/story/news/health/2021/08/16/covid-booster- shots-vaccination-united-states-biden-administra- tion/8160915002/. Courtney Subramanian, “COVID-19 booster shot for Pfizer, Moderna vaccines will be available Sept. 20”, USA Today, August 18, 2021, https://www.usato- day.com/story/news/politics/2021/08/18/covid-vaccine- booster-shots-coming-sept-20-biden-administration- says/8178505002/. 93 FDA, “Decision Memorandum”, p. 17. 94 FDA, “Decision Memorandum”, pp. 22–24. 95 FDA, “Decision Memorandum”, p. 36. 96 FDA, “Decision Memorandum”, pp. 37–38. Notes 117 97 FDA, “Decision Memorandum”, p. 40. Eric Sagonowsky, “FDA will require 50% efficacy for COVID-19 vaccines. 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Buchan et al., “Effectiveness of COVID-19 vaccines against Omicron or Delta symptomatic infection and severe outcomes”, medRxiv, January 1, 2022 (version 1), https://www.medrxiv.org/con- tent/10.1101/2021.12.30.21268565v1. Notes 118 105 Sara A. Buchan et al., “Effectiveness of COVID-19 vaccines against Omicron or Delta symptomatic infection and severe outcomes”, medRxiv, January 28, 2022 (version 2), https://doi.org/10.1101/2021.12.30.21268565. 106 Rachel Aiello, “Unvaccinated Canadian truckers will have to quarantine under new mandate, feds say”, CTV News, January 12, 2022, https://www.ctvnews.ca/health/coronavirus/unvac- cinated-canadian-truckers-will-have-to-quarantine-under-new- mandate-feds-say-1.5738185. 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Emani et al., “Increasing SARS-CoV2 cases, hospi- talizations and deaths among the vaccinated elderly popula- tions during the Omicron (B.1.1.529) variant surge in UK”, medRxiv, July 11, 2022, https://doi.org/10.1101/2022.06.28.22276926. 112 Emani et al., “Increasing SARS-CoV2 cases, hospitalizations and deaths”. 113 Katharina Röltgen et al., “Immune imprinting, breadth of vari- ant recognition, and germinal center response in human SARS-CoV-2 infection and vaccination”, Cell, January 24, 2022, https://doi.org/10.1016/j.cell.2022.01.018. 114 Matthew Gagne et al., “mRNA-1273 or mRNA-Omicron boost in vaccinated macaques elicits similar B cell expansion, neutralizing responses, and protection from Omicron”, Cell, March 24, 2022, https://doi.org/10.1016/j.cell.2022.03.038. 115 Paul Offit, “Covid-19 Boosters—Where from Here?”, New England Journal of Medicine, April 28, 2022, https://doi.org/10.1056/NEJMe2203329. 116 Niamh Allen et al., “Serological markers of SARS-CoV-2 in- fection; anti-nucleocapsid antibody positivity may not be the ideal marker of natural infection in vaccinated individu- als”, Journal of Infection, October 1, 2021, https://doi.org/10.1016/j.jinf.2021.08.012. Heather J Whitaker et al., “Nucleocapsid antibody positivity as a marker of past SARS-CoV-2 infection in population serosurveillance Notes 120 studies: impact of variant, vaccination, and choice of assay cut-off”, medRxiv, October 26, 2021, https://doi.org/10.1101/2021.10.25.21264964. Dean Follmann et al., “Anti-nucleocapsid antibodies following SARS-CoV-2 infection in the blinded phase of the mRNA- 1273 Covid-19 vaccine efficacy clinical trial”, medRxiv, April 19, 2022, https://doi.org/10.1101/2022.04.18.22271936. 117 Hassen Kared et al., “Immunity in Omicron SARS-CoV-2 breakthrough COVID-19 in vaccinated adults”, medRxiv, Janu- ary 13, 2022, https://doi.org/10.1101/2022.01.13.22269213. 118 Röltgen et al., “Immune imprinting”. Curiously, the authors nevertheless speculated that “antibodies from infection may provide somewhat decreased protection against virus variants compared to comparable concentrations of antibodies stimu- lated by vaccination.” That conclusion appears to ignore their observation that correlates of immunity have not yet been es- tablished as well as their finding of greater adaptability of the immune response in people with natural immunity, whereas “vaccine-derived imprinting affects subsequent antibody re- sponses stimulated by vaccination as well as infection.” 119 Jasmin Quandt et al., “Omicron breakthrough infection drives cross-variant neutralization and memory B cell formation”, bio- Rxiv, April 1, 2022, https://doi.org/10.1101/2022.04.01.486695. 120 Margaret L. 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Offit, “FDA: Don’t rush a move to change the Covid-19 vaccine composition”, STAT News, June 29, 2022, https://www.statnews.com/2022/06/29/fda-dont- rush-to-change-covid-19-vaccine-composition/. 147 Megan Redshaw, “Paul Offit: It ‘Felt Like the Fix Was In’ Be- fore FDA Panel Voted to Reformulate COVID Booster Shots”, The Defender, July 7, 2022, https://childrenshealthde- fense.org/defender/dr-paul-offit-covid-vaccine-mandate/. ZDoggMD, “Omicron Boosters, Kids' Vaccine & More (w/Dr. Paul Offit)”, YouTube, July 6, 2022, https://www.youtube.com/watch?v=PLo2Wwa3NNA. Da- mania describes himself as arguably the biggest advocate of vaccination on social media here: ZDoggMD, “COVID Up- date LIVE: Supreme Cour t, CDC Masks, Tribalism, & More!”, Notes 124 YouTube, January 14, 2022, https://youtu.be/BSBIWn- skIuQ?t=770. 148 Rita Rubin, “COVID-19 Boosters This Fall to Include Omi- cron Antigen, but Questions Remain About Its Value”, JAMA, July 8, 2022, https://doi.org/10.1001/jama.2022.11252. 149 Sharon LaFraniere, Noah Weiland, and Apoorva Mandavilli, “F.D.A. Authorizes Moderna and Pfizer Covid Vaccines for Youngest Children”, New York Times, June 17, 2022, https://www.nytimes.com/2022/06/17/us/politics/pfizer- moderna-vaccines-kids-fda.html. 150 Allysia Finley, “Why the Rush for Toddler Vaccines?”, Wall Street Journal, July 4, 2022, https://www.wsj.com/articles/why- the-r ush-for-toddler-vaccines-covid-pandemic-children-fda- pfizer-moderna-medicine-evidence-11656951993. 151 Marty Makary, “Why America Doesn't Trust the CDC”, Newsweek, June 10, 2022, https://www.newsweek.com/why- america-doesnt-trust-cdc-opinion-1713145. 152 Marty Makary and Tracy Beth Høeg, “U.S. Public Health Agencies Aren't ‘Following the Science,’ Officials Say”, Com- mon Sense, July 14, 2022, https://www.com- monsense.news/p/us-public-health-agencies-arent-following. 153 Hammond, “The CDC Finally Admits That Natural Immunity to SARS-CoV-2 Is Superior”. 154 Makary and Høeg, “U.S. Public Health Agencies”. 155 Centers for Disease Control and Prevention, “Director De- brief”, CDC.gov, June 18, 2022, accessed July 19, 2022, https://www.cdc.gov/about/leadership/director-debrief- ing.html. Centers for Disease Control and Prevention, “Direc- tor Debrief: COVID-19 Vaccine for Young Children”, YouTube, June 18, 2022, https://www.youtube.com/watch?v=h62OpDVdkoA. Notes 125 156 Krista Mahr and Lauren Gardner, “Low demand for young kids’ Covid vaccines is alarming doctors”, Politico, July 14, 2022, https://www.politico.com/news/2022/07/14/young- kids-covid-vaccines-low-demand-00045706.