FDA Making COVID Vax Decision Based on a Study of 10

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Might 23, 2022, Pfizer-BioNTech1 introduced preliminary outcomes from their Part 2/3 trial evaluating a three-dose vaccine schedule for youngsters 6 months to below 5 years of age could be submitted to the FDA for emergency use authorization (EUA).

Many in mainstream media are hailing this improvement as vital to kids’s well being, writing, “many dad and mom of those very younger kids have been actually anxious to get their children vaccinated”2 and “Dad and mom hoping to get their youngest kids vaccinated in opposition to COVID-19 bought some encouraging information Monday.”3

But, regardless of the continued push by mainstream media to encourage dad and mom to vaccinate the very younger, the Vaccine Monitor Survey from KFF4 discovered solely 18% of fogeys with kids below age 5 are planning to get their baby vaccinated instantly.

Dad and mom Expressing Concern for Youngsters’s Security

KFF studies {that a} bigger quantity — 38% — are planning to attend to see the unwanted effects the vaccine could have in youthful kids earlier than making a call and 27% have indicated they’ll positively not have their baby injected. Importantly, the survey additionally discovered that “Simply over half of fogeys of kids on this age vary say they don’t have sufficient details about the vaccines’ security and effectiveness for youngsters below age 5.”5

Whereas details about vaccine accidents from the COVID-19 jab has been troublesome to seek out on mainstream media, it’s obvious from these numbers that many dad and mom are involved about their kids’s security and need extra data earlier than they’re prepared to threat their well being.

A paper printed December 15, 2021, in JAMA6 referenced the earlier survey by KFF,7 which discovered 27% of fogeys of kids 5 to 11 years outdated have been taken with giving their kids the jab, which is a 9% drop from the survey in 2022. The paper8 sought to easy the waters with dad and mom who have been hesitant to vaccinate their kids by attributing concern to misinformation and a misunderstanding of what “EUA” means.

It’s fascinating to notice that the writer of the paper has obtained analysis grants from Pfizer and Moderna, and in addition serves on the advisory boards for Johnson & Johnson, Pfizer, and Merck.

The JAMA paper states the KFF survey discovered the first purpose dad and mom have been involved have been fairly the “long-term and severe antagonistic results, together with future fertility points.”9 In line with the writer, these issues have been addressed and disproven based mostly on only one yr’s value of information.

Pfizer’s 80.3% Effectiveness Is Primarily based on 10 Youngsters

Pfizer’s announcement that they have been in search of an EUA from the FDA for youngsters 6 months to below 5 years is “based mostly on 10 symptomatic COVID-19 instances recognized from seven days after the third dose and accrued as of April 29, 2022.”10

Whereas the research included 1,678 kids who obtained three doses of the formulation, the said 80.3% efficacy in kids relies on simply 10 instances. The quantity is so low that even outspoken vaccine advocate Dr. Paul Offit — co-inventor of a rotavirus vaccine11 — expressed dismay on the quantity, saying:12

“I imply, 10 kids — you are speaking about 10 kids. It is a small quantity, so it is actually exhausting to remark or this as one thing extra normal since you do not know as a result of the numbers are so small.”

Pfizer introduced these outcomes after delaying the EUA software course of to assemble extra information.13 Initially, kids within the research didn’t produce a major immune response after two doses, so the corporate delayed the request till they might give the kids a 3rd dose.

The trial reportedly was evaluating “the protection, tolerability and immunogenicity of three doses of the Pfizer-BioNTech COVID-19 Vaccine.”14 Curiously, Pfizer’s declare of 80.3% effectiveness in kids comes on the heels of a New York state Division of Well being research that confirmed vaccine efficacy in kids ages 5 to 11 years outdated fell to 12% in two months after vaccination.15

In different phrases, 7 out of 8 children who have been vaccinated had no profit from the vaccine two months after receiving the jab. The information taken from 365,502 kids confirmed a putting distinction between kids ages 11 and 12. The effectiveness in opposition to an infection in 12 yr olds was 67%, however in 11-year-old kids, it dropped to 11%.16

The information from the U.S. have been according to a report from Britain17 that confirmed effectiveness in opposition to symptomatic an infection dropped 22.6% after two months in adolescents aged 16 to 17 years.

Apparently, the Pfizer press launch printed Might 23, 2022, talked about the phrase “security” 22 occasions whereas discussing the COVID-19 vaccine for youngsters, and wrote the shot was “well-tolerated amongst 1,678 kids below 5 years of age with a security profile just like placebo.”18 The vaccine getting used on the youthful kids is one-tenth the power given to adults.19

But, the Vaccine Opposed Occasion Reporting System (VAERS)20 recorded 1,878 antagonistic occasions in kids aged 5 and 10,029 in kids aged 6 to 11 from information printed as of Might 13, 2022.

In line with the American Academy of Pediatrics,21 as of Might 2022, 35% of 5- to 11-year-olds obtained one dose and solely 28% obtained each doses of the vaccine. Should you extrapolate the antagonistic occasion numbers utilizing 35% of the pediatric inhabitants that obtained a minimum of one dose, there would have been 34,020 antagonistic occasions if 100% of kids within the U.S. aged 5 to 11 years had been given the shot.

It appears extremely unlikely that 11,907 antagonistic occasions in kids 5 to 11 reported to VAERS after a minimum of one injection would have resulted in solely “gentle or average”22 occasions in kids aged 6 months to below 5 years, or that the shot might have “a security profile just like placebo.”

Moderna Is Additionally Requesting an EUA for Youngsters Underneath 5

Moderna can also be stepping as much as the plate and requesting an EUA for a low dose shot in kids youthful than age 5. The information they’ve submitted present the vaccine is efficient 37% to 51% of the time in opposition to the COVID variant omicron.23

Paul Burton, chief medical officer for Moderna, spoke with ABC Information, saying,24 “I feel for these little kids, they actually signify an unmet medical want. I’d be hopeful that the evaluation will go on shortly and rigorously — but when it is approvable, this might be made accessible to those little kids as shortly as potential.”

It is extra probably that younger kids signify an untapped monetary windfall for the corporate, because the vaccine has confirmed to have harmful unwanted effects,25 whereas the demise fee in kids from the an infection itself is much beneath every other age group.26 However, if the vaccine is added to the pediatric vaccine schedule, and if it’s mandated like different childhood vaccines, it’ll change into an evergreen market representing billions of {dollars} to the drug firms.

Every year the CDC information vaccine effectiveness for flu photographs for all vaccine varieties in all age teams. The FDA could discover the COVID jab’s 37% effectiveness fee acceptable because the flu vaccine’s adjusted effectiveness is analogous, starting from 34% to 68% in kids ages 6 months to eight years throughout the 2015-2016 by the 2019-2020 flu seasons.27

Whereas the flu shot is a one-jab, annual occasion, so far, the CDC recommends a number of jabs with the COVID vaccine.28 This implies an grownup could obtain as much as 5 injections of an mRNA shot with unknown long-term results, which has not confirmed to successfully shield individuals in opposition to an an infection.29

For the reason that effectiveness of the COVID jab in adults and kids drops in simply weeks, it’s extremely probably the identical will occur in kids 6 months to below 5 years. Once more, the mix of a mutating virus, waning immunity and federal approval for a vaccine is a main instance of an evergreen enterprise mannequin.

Extra Individuals Are Turning Away From the Jab

In line with information launched by the CDC,30 82.7% of the U.S. inhabitants over age 5 have obtained a minimum of one dose of the COVID vaccine. In line with the CDC, that is 258,133,282 individuals as of Might 24, 2022. That is the sound chunk you’ve probably been listening to within the information. However there’s one thing else that’s worthy of noting.

Whereas the information present that 70.8% of the inhabitants are absolutely vaccinated by CDC standards, 11.9% of the inhabitants who initially obtained the primary vaccine haven’t gone again for the second dose.

The CDC additionally retains information on the quantity of people that have had their first booster or second booster, and as of Might 24, 2022, 48.4% of eligible individuals 12 years or older have obtained their first booster and simply 20.5% of eligible individuals 50 years or older have obtained their second booster.

It is very important word that the CDC recommends boosters for individuals 5 and older31 however they aren’t at present publicly monitoring that information. This implies roughly 17.3% of the inhabitants eligible for the vaccine didn’t obtain any doses. Once you add that along with the 11.9% who didn’t return for his or her second dose, it seems that 29.2% of the inhabitants have now determined they both is not going to take the vaccine in any respect or is not going to take one other.32

Why They Are Pushing Youngsters’s Vaccine Approval

On this fascinating interview with Alix Mayer, we focus on the nefarious the reason why our youngsters are being aggressively focused for the COVID-19 injection, although CDC information present they aren’t a severe threat. Mayer is board president of the Youngsters’s Well being protection California chapter and is herself vaccine injured from a sequence of vaccines she obtained 20 years in the past, earlier than touring in another country.

She’s a graduate of Duke College and Northwestern College with an MBA in finance and administration technique. Traditionally, VAERS has proven that many vaccines have a questionable security profile, particularly after they’re mixed. But information from 2021 and 2022 have instructed there’s by no means been a vaccine as harmful because the experimental mRNA gene switch injections for COVID.33

The shortage of transparency and accountability has been a power drawback inside the business, however the hazards related to the COVID jabs have actually highlighted this challenge. As a result of the injections are nonetheless below EUA, they’ve authorized immunity in opposition to legal responsibility for vaccine harm.34

As Mayer factors out, what it’s possible you’ll not understand is that though the FDA appeared to approve and license BioNTech’s Comirnaty,35 the shot continues to be administered below the EUA. One purpose for that is that after a product is absolutely licensed, the corporate additionally turns into chargeable for accidents.36

And, because the pharmaceutical firms perceive how harmful the photographs are, they do not wish to be financially chargeable for accidents. So, to get immunity for a vaccine not administered below an EUA, they should have the product positioned on the childhood vaccination schedule, below which they’re not personally liable if their vaccines injure somebody.37,38

As soon as on the kids’s schedule, it additionally permits the federal government to mandate the shot. As famous by Mayer: “That is the holy grail in case you’re a vaccine producer of a COVID vaccine proper now. You need it to be absolutely licensed, however not promote it till you get it on the kids’s schedule.”39

The explanation the pharmaceutical business is pushing for vaccines in younger kids is clearly based mostly on monetary pursuits. VAERS information present 117 kids below 18 have died due to the vaccine and 48,833 have reported antagonistic occasions and accidents as of Might 13, 2022.40

It’s essential to share this data with dad and mom who’re making lifelong choices for his or her kids and to help your native politicians whose said targets are to guard your freedoms.



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