mRNA Vax Pseudoscience: Dosing by Age, Not Weight
Pfizer’s creation of arbitrary age brackets for dosing its Covid vaccine hit a snag in the trial for children under age five. The company’s solution could place children at even greater risk of harm.
The Covid-19 mRNA vaccines require different doses to produce comparable antibody responses in human beings of different sizes. To address this issue, Pfizer created age brackets when testing the vaccine in its clinical trials.
The resulting Pfizer mRNA vaccines are dosed exclusively by age. Teens and adults ages 12 and older get two doses of 30 micrograms spaced three weeks apart. Children ages 5 years, 0 days to 11 years, 364 days get one-third that amount – two doses of 10 micrograms spaced three weeks apart. A child who turns 12 between doses one and two is instructed by the CDC to get the adult version for Dose Two. Apparently, Pfizer and the feds consider a child who is 11 years, 365 days to be more similar physically to a full-grown adult than to himself or herself just one day prior.
From the CDC’s Frequently Asked Questions:
The clinical trial of children ages 6 months, 0 days to 4 years, 364 days has tested two doses that are one-third the size of the dose for children five to eleven (i.e., two doses of 3 micrograms spaced three weeks apart.) That dose for children ages two to five failed in the clinical trial to achieve the target immune response. The company responded to this failure by announcing it would test a third dose, not just for the two- to five-year-olds but for all children in the trial.
Authorization of the vaccine for children under five is now in limbo. FDA Commissioner Janet Woodcock initially said she saw no need to wait to see whether the third dose worked. The FDA’s committee of “outside experts” was scheduled to meet on Feb. 15 to rubber stamp the Biden Administration’s decision to authorize the Pfizer vaccine in all children six months and older. The administration wanted parents to get a jump-start on injecting their children, regardless of whether the third dose was found to make a difference.
Then suddenly on Friday, Pfizer and the FDA reversed course and announced they would wait until results from the third dose are in before Pfizer submits its application for authorization of the Covid-19 vaccine in children under five.
Why the sudden cold feet? No one seems to know for certain. What we do know is that the FDA received more than 40,000 public comments (thank you!) – most of which no doubt were hostile to the agency’s proposed plan.
Meanwhile, the list of things that don’t make sense about this clinical trial for children is growing:
· By design, the clinical trials for children are far too small to test the vaccine’s ability to prevent serious infection. Covid-19 poses such little threat to children that only large trials could detect any such benefit from the vaccine. Instead, Pfizer is only measuring antibody production.
· The vaccine is being tested for antibody production against the original Wuhan strain, not the currently dominant Omicron strain, which differs significantly from the original.
· Doctors were on national television just a few days ago proclaiming that vaccination of children under five would begin in their offices on Feb. 21 (next week!), even though no vaccine had yet been authorized for this age group.
· While Pfizer acknowledged that the two-dose series failed to achieve the target immune response in children two to five, it claimed two doses had proved effective in children six months to two years old.[1] Yet, the company has now announced it will delay its application for authorization of the vaccine for these children, too, while giving them a third dose.[2] Why do they need a third dose if two doses worked? And, if infants and young toddlers are truly in mortal danger from Covid, as Pfizer and the feds would have us believe, then why are they not moving forward with authorization of the vaccine for children in this smaller age group?
· Pfizer says the third dose is being tested in children at least two months after the second dose.[3] Why such a long gap between doses two and three?
What is Pfizer hiding? Beyond all the other well-known, very serious problems with both the safety and efficacy of these injections, has the company’s attempt to dose this experimental gene therapy by arbitrary age brackets finally caught up with it? And how will its proposed solution affect safety?
Where’s the Science?
I must pause here to remind my readers that I’m only an elementary school teacher, not a doctor or scientist. Yet I am unaware of a single aspect of human physiology that is tied exclusively to age. Teething can begin anywhere between four months and a year. The ability to crawl appears between five months and 13 months. The ability to walk, between 9 and 18 months. Puberty, which ushers in major changes to the human body, starts in males between the ages of 9 and 14 and in females between 8 and 13.
These are just a few of the most obvious examples of milestones in child development that are tied directly to physiology and not specifically to age.
That children who are the same age can vary widely in their physiology is the reason drug dosages for children usually are determined by weight. Dosing decisions can also be influenced by body size, lab values, stage of illness, and/or stage of treatment.
The most commonly prescribed antibiotics, including Penicillin, Amoxicillin, and Cephalexin, all are dosed by weight in children. The analgesics Acetaminophen and Ibuprofen also are dosed by weight in children,[4] as are Benadryl for allergies and Dextromethorphan for cough.[5]
While some over-the-counter medicines for children can be dosed by age brackets, the practice is frowned upon by scientists who have studied it. From The British Journal of Clinical Pharmacology:
“This method does not take into account the changes due to developmental growth that occur within each age group… Furthermore, categorizing dosing regimens by age ranges creates an artificial discontinuity in the dose–exposure relationship across each age group, hardly substantiated by scientific evidence.” [6]
But, but, but, claims the CDC, vaccines are different than drugs. Vaccines for children can be safely and effectively dosed by age.
This claim is not supported by the facts. For starters, the childhood vaccine program in the U.S. is an unmitigated disaster. While the government has successfully blocked large studies comparing vaccinated to unvaccinated children, the results of smaller studies by independent researchers have been devastating. One such study found that children who were up to date with their vaccines were significantly more likely than their unvaccinated peers to be diagnosed with severe allergies, autism, gastrointestinal disorders, asthma, attention deficit-hyperactivity disorder (ADHD), and chronic ear infections. [7]
Another study found that vaccinated school-age children were less likely than their unvaccinated counterparts to contract chickenpox and whooping cough, but more likely to be diagnosed with pneumonia, ear infections, allergies, and neurodevelopmental disorders, including autism and ADHD. The risk of neurodevelopmental disorders in vaccinated children who had been born prematurely was found to be especially pronounced. These low- birthweight children were 6.6 times more likely than their unvaccinated peers to be diagnosed with chronic, debilitating conditions. [8]
The US childhood immunization schedule specifies 26 vaccine doses for infants by age one —the most in the world—yet the U.S. experiences a higher infant mortality rate than 33 other developed countries.[9]
Vaccines, along with the frequent use of antibiotics to treat infections caused by the vaccines, are prime suspects in our abysmal child health rankings.
Whether the childhood vaccine program would be less dangerous if the vaccines were dosed differently is anybody’s guess. The dosages for some childhood vaccines, including MMR and chicken pox, do not vary. Everyone receives the same dose. Dosages for other vaccines vary according to age. For example, the Hepatitis B vaccine, which is given to most infants in the U.S. at birth, is the same dose for everyone up to age 20, at which point the dose doubles.
That a newborn baby is given the same dose of the highly toxic Hep B series as a 19-year-old may in fact be quite dangerous. The two clinical trials for the licensed Hepatitis B vaccines offer little reassurance. One trial included only 147 children from birth to age ten (for a vaccine given to almost all newborns on their second day of life) and both trials monitored vaccine recipients for fewer than six days! [10]
Meanwhile, the Hep B vaccines have been implicated in neurodevelopmental disorders, autoimmune disease, and even death. Vaccination for Hep B is linked to hundreds of infant deaths in the CDC’s Vaccine Adverse Events Reporting System (VAERS),[11] which captures only a small percentage of the total number of adverse events.
Some doctors have pointed out that these Covid-19 injections have far more in common with gene therapy drugs than they do with traditional vaccines. So, I also reviewed the dosing regimens for gene therapy drugs. I found none that were dosed by age. When dosing varied, gene therapy drugs were dosed by either weight or lab values:
Kymriah – for acute lymphoblastic leukemia in children and young adults, is dosed by weight
Yescarta – for large B-cell lymphoma or follicular lymphoma in adults, is dosed by weight
Zolgensma – for spinal muscular atrophy in children under two, is the same dose for everyone
Breyanzi – for B-cell lymphoma in adults, is dosed based on the number of chimeric antigen receptor (CAR)-positive viable T-cells
Abecma – for multiple myeloma in adults, is dosed the same as Breyanzi
Lumakras – for lung cancer in adults, is the same dose for everyone “until disease progression or unacceptable toxicity” [12]
Rather than investigate whether arbitrary dosing decisions affect the safety of the childhood vaccine program, government officials have spent the past three decades denying the existence of widespread illness and injury from the program, just as they are now doing with the Covid-19 vaccines.
One Size Fits All!
What the CDC really seems to be saying when it claims vaccines can be dosed safely and effectively by age is that the pharmaceutical companies no longer want to run legitimate clinical trials for vaccines. They want show trials, and the CDC is only too happy to oblige.
For example, the Salk polio vaccine field trials of 1954 enrolled more than 600,000 children ages six to nine in the U.S. [13] By stark contrast, the Pfizer Covid-19 vaccine trials have enrolled a grand total of 8,300 children ages six months to 12 years. (Pfizer also spread its tiny trials among numerous countries and more than 80 clinical trial sites. Like small sample sizes and short follow-up periods, pharmaceutical companies spread out their trials so that they can more easily hide any problems, including death, that occur during the trials.) [14]
The pharmaceutical companies can comfortably run show trials for all their childhood vaccines now because Congress created H.R. 5546, the National Childhood Vaccine Injury Act of 1986, which shields these companies from financial liability for vaccine injuries.[15] As a result, vaccine makers now have every incentive to maximize their profits and little incentive to ensure safety. (People mistakenly believe that companies are uniquely protected from lawsuits for their Covid-19 vaccines. In truth, while the Covid-19 vaccines receive additional legal protections under Emergency Use Authorization, the makers of all vaccines on the childhood immunization schedule enjoy broad immunity, regardless of the harm their products cause.)
Once the show trials are complete and the necessary paperwork is filed, the companies can market one-size-fits-all products across large age brackets. This is far more profitable than having to design, test, and package different dosages based on weight or other physical factors.
The following image of the recommended vaccine schedule for U.S. children before and after the 1986 law took effect shows the bonanza for vaccine makers that resulted from the creation of their unique liability shield. Our nation’s children have become human pin cushions for the pharmaceutical industry:
Third Time’s a Charm
Now they want to add three shots for Covid. However, Pfizer’s most recent show trial – for the Covid-19 vaccine in children ages six months to five years – has hit a snag. It appears that preschoolers do not have enough in commonly physically with children as young as six months to enable Pfizer even to fake efficacy across the entire age bracket using the same dose of mRNA gene therapy.
Rather than go back to the drawing board and try a different dose for older toddlers and preschoolers, Pfizer now seeks to remedy the situation simply by adding a third 3 microgram injection for all children under five years old. The third injection is being administered at least two months after the second injection.
Once again, it is not clear why infants and toddlers up to age two need a third dose if, as Pfizer claims, the two-dose regimen worked for them. It is likewise a mystery why children will now receive their third dose at least two months after their second dose. Is this because Pfizer is concerned about the escalating side effects with each dose, as are commonly occurring in older children and adults? Does the company think that spacing the shots out will reduce the risk of severe reactions – the very same reactions that Pfizer and the feds simultaneously deny are happening?
Beyond the serious safety and efficacy issues that exist with these gene therapy products across all age groups, I can think of several problems with this proposed three-dose regimen in children under five.
It is more difficult for parents to comply with a three-dose regimen. Three doses require three appointments; three trips, with young children in tow, to wherever the shots are administered; and quite possibly, numerous absences from work as parents are forced to stay home with children who develop fevers and other common side effects after each dose.
Already, tens of millions of older children and adults have dropped out of the Covid-19 vaccine program after Dose One.[16] Presumably, many are avoiding Dose Two because of troubling side effects from their first dose. Requiring three doses increases the odds that side effects will prevent many children from completing the series.
By Pfizer’s own admission, children ages two to five will be running around for at least 11 weeks with suboptimal vaccinal antibodies. This, in my opinion, is by far the biggest problem with a three-dose regimen, assuming, for the sake of argument, that it offers any benefit at all.
The Case for Quarantine
As other Substack writers have documented and published studies have intimated, these gene therapy injections are never neutral.[17] [18] [19] [20] They appear always to be demonstrating either positive or negative efficacy. Belgium virologist Geert Vanden Bossche warned us many months ago that the partially vaccinated are at heightened risk, relative to the unvaccinated, of contracting Covid due to suboptimal vaccinal antibodies, just as the fully vaccinated are heightened risk once their vaccinal antibodies fade. A three-dose regimen spread out over 11 weeks potentially means at least 11 weeks of negative efficacy right out of the gate for older toddlers and preschoolers, and increased risk of serious illness from a virus that poses little threat to unvaccinated children in this age group.
It is possible that last Friday’s announcement to delay authorization means that the data already are in, and that the three-dose regimen has failed, in which case the Covid vaccine for children under five may be sunk and Pfizer might simply be attempting to delay the bad news for its shareholders.
However, if Pfizer goes forward with this three-dose regimen, which executives clearly see as their best option after flubbing the trial by creating arbitrary age brackets for dosing, then it seems to me that all vaccinated children should be placed in strict quarantine for the entire 11 weeks between Dose One and Dose Three. Vaccinees should be shielded from any chance of Covid exposure until their vaccinal antibodies are optimized.
This, of course, is entirely impractical, so Pfizer and the feds will never mention it. Instead, they simply will count all children under five as unvaccinated until the children have completed the three-dose series. That way if toddlers and preschoolers suffer a poor outcome from Covid because of suboptimal vaccinal antibodies brought on by doses one and two, the public can blame the virus, not the vaccine. To date all CDC studies of Covid-19 vaccine efficacy have either 1) counted adults and teens who are between doses one and two as unvaccinated; or 2) screened these partially vaccinated individuals out of their studies altogether.[21]
There is a method to the CDC’s madness, and as usual, it has nothing to do with health or safety.
Please scroll down past the references to share your thoughts.
Thank you for reading!
[1] Pfizer and BioNTech Provide Update on Ongoing Studies of COVID-19 Vaccine | Pfizer
[2] Pfizer and BioNTech Provide Update on Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age | Pfizer
[3] Pfizer and BioNTech Provide Update on Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age | Pfizer
[4] rs_commonmeds.pdf (aapd.org)
[5] Children's Medicine Dosage by Weight and Age | St. Louis Childrens Hospital (stlouischildrens.org)
[6] What is the right dose for children? (nih.gov)
[7] JTS-7-459.pdf (oatext.com)
[8] JTS-3-186.pdf (oatext.com)
[9] Infant mortality rates regressed against number of vaccine doses routinely given: Is there a biochemical or synergistic toxicity? (nih.gov)
[10] MEET ICAN ATTORNEY AARON SIRI - The HighWire: Screen shot at 1:24:15. Relevant discussion starts at 1 hr, 16 min.
[11] The Flawed Logic of Hepatitis B Vaccine Mandates • Children's Health Defense (childrenshealthdefense.org)
[12] Lumakras (Sotorasib Tablets): Uses, Dosage, Side Effects, Interactions, Warning (rxlist.com)
[13] “A calculated risk”: the Salk polio vaccine field trials of 1954 (nih.gov)
[14] Pfizer and BioNTech Provide Update on Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age | Pfizer
[15] H.R.5546 - 99th Congress (1985-1986): National Childhood Vaccine Injury Act of 1986 | Congress.gov | Library of Congress
[16] Crickets from Media as Millions Skip 2nd Vax Dose (substack.com)
[17] Covid infections and deaths SOAR after the first vaccine dose (substack.com)
[18] BNT162b2 induces SARS-CoV-2-neutralising antibodies and T cells in humans | medRxiv
[19] Vaccination status and COVID-19 related mortality: A hospital based cross sectional study (nih.gov)
[21] New England Journal of Medicine Puts Lipstick on a [CDC] Pig, Again (substack.com)
Very informative and very well written. Thank you. There was a time when a mainstream magazine or newspaper would publish an article of this caliber and praise would be heaped upon the author.
Fantastic article!!! 🙌