COVID
There Are No Licensed COVID Vaccines for Kids Under 12 — But CDC Wants Babies to Get 3 Pfizer Shots by Age 9 Months
According to the latest CDC guidance, 9-month-old babies must receive multiple doses of an unlicensed mRNA COVID-19 vaccine to be considered “up to date” with their COVID-19 vaccination.
The CDC’s updated guidance, issued Aug. 30, states that children — as young as 6 months old — should get either two doses of the 2024-2025 Moderna vaccine or three doses of the 2024-2025 Pfizer-BioNTech vaccine.
If getting the new Pfizer shot, the baby is supposed to receive the first dose at 6 months, the second dose three weeks later and the third dose at least eight weeks after the second dose — meaning, that by 9 months old, babies are supposed to have received three Pfizer shots.
If getting the latest Moderna shot, the CDC recommends babies get the first dose at age 6 months and the second dose a month later.
The latest Pfizer and Moderna COVID-19 shots for children under 12 are unlicensed in the U.S. The U.S. Food and Drug Administration (FDA) has granted only emergency use authorization (EUA) for the vaccines.
Children’s Health Defense (CHD) CEO Mary Holland told The Defender, “The earlier COVID shots have been proven unsafe and ineffective. Now we’re asked to believe that newer versions are miraculously safe and effective?”
“This is an insult to people’s intelligence,” she said, “I pray that parents will have the good sense to say no to these dangerous and unnecessary shots for babies.”
As of July 28, 37,814 deaths following COVID-19 vaccination had been reported to VAERS, the Vaccine Adverse Event Reporting System, run by the FDA and CDC.
Of those, 187 reports were for children and teens under 18. Nearly 13,000 reports listed the age as “unknown.”
VAERS analyst and expert Albert Benavides recently told The Defender he believes VAERS is “throttling” and underreporting deaths of all ages following COVID-19 vaccination.
Meanwhile, the CDC continues to tell the public that COVID-19 vaccines are “safe and effective.”
CDC ‘absolutely misleading’ public on safety of EUA vaccines
Holland said the CDC is “absolutely misleading” the public by asserting that COVID-19 EUA vaccines are safe and effective because EUA vaccines are not held to the same safety or efficacy standards as licensed vaccines.
“By law,” she explained, “EUA products ‘may be effective,’ and they have not undergone the safety testing required to permit licensing.”
“This is one more horrific example of the CDC putting profits before people and acting as an unethical arm of Big Pharma’s marketing operation,” Holland added.
CHD Chief Scientific Officer Brian Hooker agreed. “It is criminal that these untested vaccines are being recommended to infants and children, especially given the fraudulent tactics to market them to an unsuspecting public,” Hooker told The Defender.
There’s no licensed COVID vaccine for kids under 12
There are still no licensed COVID-19 vaccines available for children under 12, Hooker said — so all COVID-19 vaccines given to young kids are EUA products.
The FDA’s website on EUA for medical products states that EUA vaccines only have to meet the standard of “may be effective” as long as if, “based on the totality of the scientific evidence, it is reasonable to believe that the product may be effective for the specified use.”
“The ‘may be effective’ standard for EUAs provides for a lower level of evidence than the ‘effectiveness’ standard that FDA uses for product approvals,” the website states.
Before a vaccine can be fully licensed, the vaccine maker typically is required to conduct numerous clinical trials to demonstrate that the product is safe. However, the safety requirements for EUA are more flexible.
According to the FDA:
“The amount and type(s) of safety information that FDA recommends be submitted as part of a request for an EUA will differ depending upon a number of factors, including whether the product is approved for another indication and, in the case of an unapproved product, the product’s stage of development.”
Despite this, the first statement on the CDC’s “6 Things to Know about COVID-19 Vaccination for Children” says, “COVID-19 vaccination for children is safe.”
Risks outweigh benefits for kids
Hooker said the CDC’s actions are especially problematic as, historically, the meaning of “safe” has been interpreted by regulatory authorities as meaning that the benefits of a drug outweigh its risks.
“With the risk to children of dying from a COVID-19 infection being statistically zero, it is unclear if there is any benefit,” he said.
Meanwhile, the CDC still claims that “while adverse reactions are rare, the benefits of COVID-19 vaccination outweigh the known risks of COVID-19 and possible severe complications.”
Pfizer fact sheet more forthcoming about risks
For licensed vaccines, the CDC typically provides an official vaccine information statement (VIS) that describes the vaccine’s risks and potential benefits.
According to the CDC website, “Federal law requires that healthcare staff provide a VIS to a patient, parent, or legal representative before each dose of certain vaccines.”
However, for EUA COVID-19 vaccines, the CDC directs people to “fact sheets” — produced by the vaccine manufacturer, not the CDC, and authorized by the FDA — which detail the product’s risks and benefits.
There is no federal law requiring healthcare providers to share these fact sheets with patients, or parents of minors, before a COVID-19 vaccination.
“Pfizer’s own ‘fact sheet’ for its latest COVID-19 vaccine appears to give a more accurate picture [of the vaccine’s risks] than the CDC’s own websites,” Hooker said. “Shouldn’t the CDC be more a watchdog than Pfizer?”
For example, Pfizer’s fact sheet states, “A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product.”
The Pfizer fact sheet also acknowledges that its vaccine “may not protect everyone” and that reported side effects associated with the Pfizer vaccines include myocarditis and pericarditis.
Hooker pointed out that research has shown that vaccine-induced myocarditis, inflammation of the heart, and pericarditis, inflammation of the tissue surrounding the heart, can be fatal.
He urged parents to “read between the lines” when assessing the CDC’s COVID-19 vaccination recommendation for babies and children.
“Most of all,” he added, “use common sense to decide if the CDC’s and the FDA’s logic is sound.”
Ray L. Flores II, Esq.
Ray Flores is a health freedom rights attorney. His interest in natural living started in the 1980's when he began working in the burgeoning natural foods industry.
Suzanne Burdick, Ph.D.
Suzanne Burdick, Ph.D., is a reporter and researcher for The Defender based in Fairfield, Iowa.
No comments:
Post a Comment