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Pfizer Says It Needs to Study a Third Dose for Toddlers
-Pfizer announced their experiments on children 6 months and older were unsuccessful in 2- to 5-year-olds as they didn't produce an immune response, leading to a recommendation for a third shot and delaying the EUA for the youngest citizens
-Although the experiments produced a strong response in children 6 months to 24 months and 5 to 12 years, the company announced they were evaluating increasing these doses as well
-The study is listed as a phase 1, 2 and 3 model, evaluating the safety, dose and efficacy simultaneously, a strategy seldom, if ever, used.
Data collection and analysis will be completed in one year on a population with little risk of the illness
-Despite the readily available and public data, some continue to call for a shot for children for the sake of herd immunity. Yet, according to a recent engineering analysis more people have died from the shot in less time than from the disease
Children are the future. Over the centuries, many have suffered atrocities at the hands of adults. Yet the recent push to inject children with a genetic experiment may be one of the worst public health offenses perpetrated on a population of people who are unable to speak for themselves, do not have a legal voice and depend on adults to protect them.
In the push to ensure there is a shot in every arm, Pfizer recently announced the clinical trials for the COVID jab in children has hit a snag.1 And yet, you would be hard-pressed to call the “Warp Speed” creation, testing and manufacture of this shot anything but implausible.
Historically, Vaccines Have Been Pulled After Reported Damage
At no other time in history have “vaccines” been created and distributed with such impunity. The closest scenario occurred in 1976 when one young soldier died from a new form of flu that triggered fear and the subsequent development of a flu vaccine aimed at 80% of the American public.2 While the World Health Organization took a “wait and see” approach, the CDC jumped in with both feet.
It was a pandemic that never materialized and those who were the real victims were the roughly 450 people who developed Guillain-Barre syndrome,3 a rare neurological disorder, and the roughly 53 who died from the vaccine.4
The rush to produce the newest vaccine iteration ostensibly began in early 2020 after the WHO announced SARS-CoV-2 would produce a worldwide pandemic5 and an early, flawed mathematical model predicted millions of deaths in America.6 Yet, this was not a medical product that fit the definition of a “vaccine.”
It was something never heard of before in vaccinology, based on an experimental mRNA technology that triggers your body to produce a spike protein. It was so new, in fact, that the CDC decided the definition of “vaccine” had to be changed7 and scientists were unsure of how the body would react to the genetic therapy injection. While the swine flu injection was pulled after 45 million shots were given when 53 people died,8 the COVID-19 injection will have a different history.
According to data from the Vaccine Adverse Events Reporting System (VAERS), collected by the CDC and FDA, there have been 20,244 deaths recorded in conjunction with the COVID jabs as of December 10, 2021,9 12 months after the first shot was given in the U.S.10 According to Bloomberg, as of December 23, 2021, there have been 499 million doses given in America.11
It is difficult to compare these numbers since two of the three available COVID shots require a double shot, so there haven’t been 497 million people vaccinated. Yet, the adverse events and deaths are also occurring after just one shot.
Taken at face value, the U.S. shut down the vaccination program in 1976 after 0.000117% of people died, while the VAERS estimate is that 0.00407% of people have died after a COVID injection (using Bloomberg’s December 21 dose numbers of 497 million).
In other words, based on the percentage of people who have died, 3,378% more died after the COVID injection than from the swine flu injection. There have been 965,841 adverse events reported, including permanent disabilities and heart attacks in young people. And yet, stakeholders in the shot insist the next generation of Americans must take it.
Pfizer Announced Youngest Kids Not Responding to the Shot
Pfizer has been working on a clinical trial12 to evaluate the safety of the mRNA jab in healthy children, intending to create a dose for children 6 months and older. Endpoints reports Pfizer recently announced “non-inferiority was not met for children between the ages of 2 and 5 when compared to older teenagers in the current trial.”13
Originally, the company hoped to apply for an emergency use authorization (EUA) for the youngest by the end of December 2021. However, since the data have not proven successful, they hope to submit for the EUA “in the first half of 2022,”14 one short year after starting the experiment. The company said it has made a shift to giving three doses in smaller amounts to raise the immune response.15 They explain the decision this way:
“Compared to the 16- to 25-year-old population in which high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population but not for the 2- to under 5-year-old population in this analysis …
The decision to evaluate a third dose of 3 µg for children 6 months to under 5 years of age reflects the companies’ commitment to carefully select the right dose to maximize the risk-benefit profile …
Pfizer and BioNTech also plan to evaluate a third dose of the 10 µg formulation in children 5 to under 12 years of age.”
If the two-dose regimen makes the changes to the immune system in the 6- to 24-months group and 5- to 12-year age groups that the company is looking for, why move to a three-dose regimen for them if not for financial gain?
Pfizer Pushing the Envelope With a Phase 1-2-3 Trial
It is important to note that the trial is listed in Clinical Trials as a phase 1-2-3 study.16 Phase 1 trials17 are generally concerned with establishing drug safety and dose range in a small number of healthy volunteers. Phase 2 trials determine the effectiveness of the drug using approximately 100 to 300 volunteers and often last from several months to two years.
Phase 3 studies are the final evaluation performed over multiple centers with up to several thousand patients to test the drug safety and efficacy. A search of the Clinical Trials database shows only one study in several hundred thousand studies listed that are simultaneously in Phase 1, 2 and 3.18
But not all parents and scientists are appalled by the experimentation on 6-month-old babies in the face of massive adverse events and permanent damage to adults. One mother and epidemiologist, Katelyn Jetelina,19 wrote she finds comfort that the clinical trial found errors and was surprised when it failed. She wrote:20
“As a mom, I was shocked and heartbroken. My girls were so close to getting their shot. We’ve waited so long and really needed a win.”
Children Are Not at Risk From COVID
Despite low rates of infection and death, the American Academy of Pediatrics calls “vaccines our best hope to end the COVID-19 pandemic.”21 However, we do know that the risk to children birth to 17 years is so small as to be inconsequential.
The CDC22 reports a total number of deaths in 2020 and 2021 from COVID-19 in this age group as 668 as of December 23, 2021. One study23 posted July 7, 2021, looked at deaths in the U.K. during the first 12 months of the pandemic and found that 99.995% of children survived.
Between March 2020 and February 2021 only 25 children under the age of 18 had died in the U.K. as a direct result of the infection. The researchers found there were 61 children with positive test results, but 36 deaths were attributed to other causes. This is a 2-in-1 million absolute mortality rate for children.24
More Children Have Died From the Shot Than the Illness
To compare the number of deaths from COVID illness against those who have died from the genetic therapy injection, we must address the known under-reporting factor (URF) in VAERS,25 which is a passive reporting system and the only area where the public can voluntarily report adverse events, including death.
The VAERS document is long and time-consuming,26 and while much of the information is necessary, the form can easily become overwhelming when doctors have multiple patients with adverse events from the COVID-19 shot.27 Several factors likely contribute to the URF, including the length of the form, lack of knowledge of the system and a growing physician shortage.28
One investigative team updated the URF in November 2021.29 The original number had been set in an early grant report submitted by the U.S. Department of Health and Human Services, stating “fewer than 1% of vaccine adverse events are reported.”30 Using an engineering analysis of the available data and judgment based on peer-reviewed literature and expertise of the scientists, a URF of 41 was determined.31
One of the paper’s writers, Steve Kirsch, recognized the URF would affect the number of children who died after taking the vaccine versus the number who have died from the illness. He used CDC data ending December 8, 2021, which showed 757 children younger than 18 were casualties of COVID-19. As of December 22, 2021, that number had grown to 790 casualties.32
He then found 32 deaths from the vaccine in VAERS data ending December 3, 2021.33 Using the URF of 41 and the data Kirsch took from VAERS and the CDC, this suggests there have been 1,312 deaths that likely were caused by the injection as compared to the 757 deaths caused by the illness. If you do the math, this means the shot has killed roughly 173% more children than the illness.
Using the same URF of 41 and the current VAERS data34 ending December 10, 2021, we can estimate there are likely 39,599,481 adverse events and 830,004 deaths caused by the injection. This is vitally important as the total number of deaths recorded for COVID-19 as of December 22, 2021, is 807,787.35 This means the shot possibly has killed more children and adults than the virus, and in less time.
Additionally, when you look at the data from the CDC,36 you note that there were 36,931 more deaths recorded in 2021 after the release of the vaccine than in 2020 when the illness first emerged from Wuhan. Although WHO didn’t declare the pandemic until March 2020, the U.S. has reclassified deaths before that, finding the first from COVID happened January 9, 2020.37
Vaccinating Children for Herd Immunity Is Unethical
Despite the readily available data, the American Academy of Pediatrics, CDC, FDA and others continue to call for vaccination in the most vulnerable in the population: our children. Their developing immune system and inability to protect themselves create a vulnerability that opens them up to unfathomable damage.
Sadly, medical professionals who express their concern are roundly ignored, despite the growing number of those health care professionals who are stepping forward. Among them is cardiac surgeon and patient advocate Dr. Hooman Noorchashm, who sent a public letter38 to the FDA commissioner in January 2021.
In it, he detailed the risks of vaccinating individuals who have previously been infected with SARS-CoV-2, or who have an active SARS-CoV-2 infection. It was subsequently removed from Medium.com.39
Immunologist Dr. Bart Classen also warned in early 2021 there is troubling evidence suggesting some mRNA shots may cause prion diseases such as Alzheimer’s and ALS,40 and Dr. J. Patrick Whelan, a pediatric rheumatologist specializing in multisystem inflammatory syndrome, has expressed concern about mRNA shots’ ability to cause “microvascular injury to the brain, heart, liver and kidneys in a way that is not currently being assessed in safety trials.”41
Health officials are telling parents that children should be vaccinated for the sake of herd immunity. What is largely ignored are the studies that show children are not driving the pandemic and, in fact, appear less likely to transmit the virus than adults.42 The Children’s Health Defense notes:43
"In short, public health leaders say, parents must 'vaccinate the young to protect the old.' Given the federal government's estimate that one vaccine injury results from every 39 vaccines administered, it seems clear that officials expect children to shoulder 100% of the risks of COVID vaccination in exchange for zero benefit.”
An opinion piece in The BMJ24 by Peter Doshi, Elia Abi-Jaoude and Claudina Michal-Teitelbaum highlight why we must not force children to take the COVID shot simply because it might help vulnerable adults. They write:44
“Even if we were to assume this protection does exist, the number of children that would need to be vaccinated to protect just one adult from a bout of severe covid-19 — considering the low transmission rates, the high proportion of children already being post-covid, and most adults being vaccinated or post-covid — would be extraordinarily high.
Moreover, this number would likely compare unfavorably to the number of children that would be harmed, including for rare serious events. A separate, but crucial question is one of ethics. Should society be considering vaccinating children, subjecting them to any risk, not for the purpose of benefiting them but in order to protect adults? We believe the onus is on adults to protect themselves.”
Doshi was even more blunt in his June 10, 2021, public comment45 to the FDA’s Vaccines and Related Biological Products Advisory Committee. There, he pointed out that the FDA can only authorize the use of a medical product in a population if the benefit outweighs the risk in that same population.
This means that even if adults were to benefit, the COVID shots cannot be authorized for children unless children will actually benefit from it themselves. In the case of COVID-19 injections, children cannot benefit, seeing how they only have a 0.005% risk of death in the first place. Healthy children have died shortly after the jabs and dozens of cases of heart inflammation have been reported.
Since when, in the history of public health, have children been sacrificed to protect the sick and elderly? Public health authorities have completely reversed the conventional risk/reward analysis.
1 Endpoints News, December 17, 2021
2 Smithsonian Magazine, February 6, 2017
3 Smithsonian Magazine, February 6, 2017, paras 1, 4, 6, 10
4, 8 Fox News, May 6, 2021
5 Acata Biomed, 2020;91(1)
6 Cato Institute, April 21, 2020
7 Citizens Journal, September 13, 2021
8 Fox News, May 6, 2021
9 VAERS, COVID Data
10 Washington Post, December 14, 2020
11 Bloomberg, December 21, 2021
12, 16 Clinical Trials, NCT04816643
13, 14 Endpoints, December 17, 2021
15 Pfizer, December 17, 2021
17 University of Cincinnati College of Medicine, Clinical Trial Phases Defined
18 Clinical Trials, Search Details
19 Your Local Epidemiologist, December 20, 2021
20 Your Local Epidemiologist, December 20, 2021, para 2 under bullets
21 Healthy Children, When can kids get the COVID-19 vaccine or booster?
22 Centers for Disease Control and Prevention, Weekly Updates by Select Demographic and Geographic Characteristics, Table 1 Yearly tab, top line
23 Research Square July 7, 2021 DOI: 10.21203/rs.3.rs-689684/v1
24 Research Square July 7, 2021 DOI: 10.21203/rs.3.rs-689684/v1 Interpretation
25 Vaccine Adverse Event Reporting System
26 Vaccine Adverse Event Reporting System, Report an Adverse Event with a Writable PDF Form
27 The Catholic World Report, November 1, 2021
28 AAMC, June 26, 2020
29 Steve Kirsch, November 1, 2021
30 Health and Human Resources, Grant Final Report
31 Steve Kirsch, November 1, 2021, Summary page 61
32 Centers for Disease Control and Prevention, December 22, 2021, last table
33 Steve Kirsch, December 12, 2021
34 OpenVAERS COVID Data
35, 36 Centers for Disease Control and Prevention, Daily Updates of Totals by Week and State
37 Live Science, September 3, 2021
38 Citizen Wells, November 29, 2021
39 Medium February 15, 2021
40 Microbiology & Infectious Diseases 2021; 5(1): 1-3 (PDF)
41 University of California Public Comment related to consideration of vaccines against SARS-CoV-2, December 8, 2020 (PDF)
42 Pediatrics 2020; doi: 10.1542/peds.2020-004879
43 Children’s Health Defense February 11, 2021
44 The BMJ Blog July 13, 2021
45 YouTube VRBPAC June 10, 2021 Peter Doshi Minute 4:11:30
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