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Friday, October 7, 2022

Moderna and Pfizer Seek Booster Authorization for Children

 

Moderna and Pfizer Seek Booster Authorization for Children

Pfizer and Moderna are both seeking emergency use authorization for their bivalent COVID boosters for children.

STORY AT-A-GLANCE

  • Pfizer and Moderna are both seeking emergency use authorization for their bivalent COVID boosters for children. Moderna is seeking authorization for children ages 6 through 17, while Pfizer’s shot is for children aged 5 through 11

  • The U.S. Centers for Disease Control and Prevention expects the bivalent boosters will be available for children aged 5 to 11 by mid-October 2022

  • In the U.S., both bivalent boosters will contain mRNA against the original Wuhan strain and Omicron variants BA.4 and BA.5. (In the U.K., Moderna’s booster targets the Wuhan strain and BA.1, an earlier Omicron strain no longer in circulation)

  • The effectiveness of Pfizer’s booster is based on antibody levels in eight mice, which cannot tell you anything about the level of protection you might receive. Moderna’s booster is also based on antibody levels in mice, although the exact number is unknown

  • When it comes to safety, there’s not even mouse data. The safety is assumed based on the original shots, even though the safety data on those is shocking beyond belief. As of September 16, 2022, the U.S. Vaccine Adverse Events Reporting System (VAERS) had logged 55,733 reports of injuries and deaths in children under the age of 18


Even as more damning data are coming to light, Pfizer and Moderna are both seeking emergency use authorization (EUA) for their bivalent COVID boosters for children. Moderna is seeking authorization for children ages 6 through 17, while Pfizer’s shot is for children aged 5 through 11.1

According to Reuters,2 “the U.S. Centers for Disease Control and Prevention ... expects COVID-19 vaccine boosters targeting circulating variants of the virus to be available for children aged 5-11 years by mid-October.”

Moderna’s new bivalent COVID booster, mRNA-1273.222, sold under the brand name “Spikevax bivalent Original/Omicron,” was authorized for adults over the age of 18 at the end of August 2022.3

In the U.S., the adult dose contains 25 micrograms of mRNA against the original Wuhan strain and 25 mcg of mRNA targeting Omicron variants BA.4 and BA.5.4 In the U.K., Moderna’s bivalent booster (mRNA-1273.2145) contains mRNA against the original Wuhan strain and BA.1,6 an earlier Omicron strain that is no longer in circulation.7 8

Pfizer’s bivalent booster also contain mRNA against the Wuhan strain, BA.4 and BA.5. The two bivalent boosters are only be available to those who have already received the primary two-dose series and/or a monovalent booster at least two months ago.9

It’s probably safe to assume the same rule will apply to children. As of late September 2022,10 38% of American children aged 5 to 11 had received one initial dose and 31% have received two doses.11 In the 12- to 17-year-old age group, 67% have had one dose and 57% two doses. Those with two doses are likely the only ones who will be eligible for the bivalent booster, if authorized.

Bivalent Boosters Have Only Been Tested on Mice

friday roundtable new booster

For decades, the U.S. Food and Drug Administration has had additional safeguards in place for children who participate in medical research.12 With the advent of COVID shots, all of that has been tossed out the window, as children are now being used as medical guinea pigs without any safeguards whatsoever.

It’s really important to realize that these bivalent boosters have been reformulated with new, untested mRNA, yet they’ve only been tested on mice. Despite that, the FDA is now considering giving them to young children.

The effectiveness of Pfizer’s booster is based on antibody levels in eight mice,13 which cannot tell you anything about the level of protection you might receive. Moderna’s booster is also based on antibody levels in mice, although the exact number is unknown.

“Safety is assumed based on the original shots, even though the safety data on those is shocking beyond belief. As of September 16, 2022, the U.S. Vaccine Adverse Events Reporting System (VAERS) had logged 55,733 reports of injuries and deaths in children under the age of 18.”

When it comes to safety, there’s not even mouse data. The safety is assumed based on the original shots, even though the safety data on those is shocking beyond belief. In the short-term, the original COVID shots have between them resulted in 1,417,671 adverse event reports (logged with the U.S. Vaccine Adverse Events Reporting System or VAERS as of September 16, 202214).

That includes 177,973 hospitalizations, 58,024 permanent disabilities, 34,107 life threatening events and 31,071 deaths. For children under the age of 18 alone, there are 55,733 reports of injuries and deaths.

If that’s not cause for alarm, I don’t know what is. It’s certainly not “strong evidence” for safety! What’s more, due to widespread underreporting, you have to multiply those already staggering numbers by underreporting factor of 41 (or more) to get an idea of the true impact.

And, if you still believe the pediatric trials were exhaustive, understand that the monovalent Pfizer booster authorized for children aged 5 to 11, back in May 2022, was based on the antibody levels of just 67 children.15 This is so far outside the norm of what’s historically been required for a drug trial, it’s just ridiculous.

1 in 800 Absolute Risk of Serious Side Effects

While VAERS data paint a clear picture of what’s at stake for parents who opt to inject their children with this genetically engineered bioweapon, we now also have other data showing just how bad of an idea that is.

A recent study16 17 in the journal Vaccine — coauthored by some of the most trusted medical scientists in the world, including Peter Doshi, an associate professor of pharmaceutical services research and a senior editor at The BMJ — looked at data from the FDA, Health Canada and the Pfizer and Moderna trials to assess the risks of Pfizer’s and Moderna’s COVID shots.

They concluded the absolute risk of a serious adverse event from the mRNA shots was 1 in 800, which massively exceeds the risk of COVID-19 hospitalization found in randomized controlled trials.

The risk COVID infection poses to children is even more infinitesimal — especially Omicron infection, which presents as a mild cold in most people — making a 1 in 800 risk of a serious side effect unacceptable beyond description.

Statistics show the rate of COVID-19 associated hospitalization among children aged 5 to 11 is 0.0008%.18 In real-world terms, that’s so close to zero you cannot lower it any further. Additionally, as reported by Clark County Today,19 “Pfizer trial data20 [show] the chance of death in children from the shot is 107 times higher than death from COVID-19.”

Other Data That Confirm Lack of Safety

is the covid vaccine safe for my kids

Other data are also reviewed in a recent paper21 22 by cardiologist Dr. Aseem Malhotra, who initially recommended the shots but has since changed his mind about their safety. For example, Israeli data show post-jab myocarditis is occurring at a rate of 1 in 6,000. Data from male children and teens in Hong Kong found myocarditis at a rate of 1 in 2,700.

As noted by the Vaccine Safety Research Foundation in the video above, myocarditis — one of the recognized effects of the COVID jab — “has a mortality rate of 25% to 56% within three to 10 years, owing to progressive heart failure and sudden cardiac death.”

Norwegian data show the rate of serious adverse events post-jab is 1 in 1,000 after two doses of Pfizer, and the British Yellow Card system shows 1 in 120 people who have received at least one mRNA injection suffer an adverse event “that is beyond mild.” These are simply extraordinary risk ratios, and there’s no telling what the long-term effects might be, say 10 or 20 years from now.

Trial Showed COVID Jab Increases Infection Risk in Babies

dr craig exposes how pfizer twisted their clinical trial data for young children

According to CDC director Dr. Rochelle Walensky, “rigorous scientific review” has proven the COVID shots to be safe and effective in infants and young children.23 However, as detailed by diagnostic pathologist Dr. Clare Craig24 (video above), Pfizer twisted its clinical data for young children to achieve a desired result.

Craig points out that of the 4,526 children, aged 6 months to 4 years, who participated in Pfizer’s trial, 3,000 didn’t make it to the end of the trial. Why did two-thirds of the children drop out? Oftentimes, this happens when side effects are too severe for the participant to continue. Here, we don’t know why two-thirds of the participants were eliminated, and “on that basis alone, this trial should be deemed null and void,” Craig says. Moreover:

  • Six of the children, aged 2 to 4 years, in the vaccinated group were diagnosed with “severe COVID,” compared to just one in the placebo group. So, what this actually shows is that the likelihood the shot is causing severe COVID is higher than the likelihood that it’s preventing it.

  • The only child who required hospitalization for COVID was also in the “vaccinated” group.

  • In the three weeks following the first dose, 34 of the children in the vaccinated group and 13 of the unvaccinated children were diagnosed with COVID. That means the children’s risk of developing symptoms of COVID within the first three weeks of the first dose actually increased by 30%! These data were ignored.

    Between doses two and three, there was an eight-week gap, and the vaccinated arm again experienced higher rates of COVID. This too was ignored. After the third dose, incidence of COVID was again raised in the vaccine group, and this was ignored as well.

    In the end, they only counted three cases of COVID in the vaccine arm and seven cases in the placebo group. They literally ignored 97% of all the COVID cases that occurred during the trial to conclude that the shots were “effective” in preventing COVID.

  • While they claim the triple-dose regimen reduced COVID, 12 of the children actually caught COVID twice in the two-month follow-up, and 11 of them were vaccinated.

  • The confidence interval for Pfizer’s jab is -370% at the lower end of the 95%, which suggests children who get the jab are nearly four times more likely of getting sick with COVID than their unvaccinated peers.25

Why Are They Targeting Children Who Don’t Need These Shots?

Ever since the COVID shots were first authorized for young children,26 the question of why has been raised. Certainly, it’s not because children are in grave danger of dying from COVID.

The most likely explanation for the FDA’s and CDC’s irrational behavior is that they’re helping the drug makers to get the mRNA shots onto the childhood vaccination schedule, as that is the fastest and easiest route to get permanent liability shielding.

Once the vaccine is on the childhood vaccination schedule, the vaccine makers are permanently shielded from liability for injuries and deaths that occur in any age group, including adults. You can learn more about this indemnification process in “The Real Reason They Want to Give COVID Jabs to Kids.”

So, the end goal is likely to get permanent immunity against liability for injury and death from the COVID shots in all age groups, and to get there, they first need the EUA to cover all children. And, since the FDA is now authorizing reformulated mRNA shots without additional testing, using the flu vaccine model, it seems they want to make sure they have annually updated boosters included in the EUA for children as well.

UK Bans COVID Jab for Under-12

Meanwhile, the U.K. recently rescinded the COVID jab for children under the age of 12, unless they’re in a high-risk medical category. As reported by The Guardian September 6, 2022:27

“The UK Health Security Agency (UKHSA) said children who had not turned 5 by the end of last month would not be offered a vaccination, in line with advice published by the UK’s Joint Committee on Vaccination and Immunisation (JCVI) in February 2022. UKHSA said the offer of COVID jabs to healthy 5- to 11-year-olds was always meant to be temporary.”

Similarly, as of September 1, 2022, Denmark no longer offers the COVID jab to children between the ages of 5 and 17, citing the low risk posed by COVID infection.28 Children with only one dose will not be required to get a second, and no boosters will be offered to this age group.

Sweden opted not to recommend the shot for children between 5 and 11 from the start, as the Swedish Health Agency felt the benefits did not outweigh the risks,29 so boosters for kids are unlikely to be an issue there either.

In the U.S., Florida has gone on record rejecting all COVID shots for children under 5.30 Parents who want to get their toddlers jabbed have the freedom to do so, but it’s not recommended by the state.

Protect Your Children From Medical Experimentation

If you’re still unsure whether the COVID shot is the “right” choice for your child, please read through Dr. Byram Bridle’s “COVID-19 Vaccines and Children: A Scientist’s Guide for Parents,”31 published by the Canadian COVID Care Alliance. It goes through how the shots work, what the known side effects are, results from the clinical trial, the effects of the spike protein and much more.

Side effects from the new bivalent boosters are assumed to be about the same as for the original shots,32 but there’s no guarantee of that. They could be milder, or they could be worse.

In my view, the chances of them being worse is higher, for the simple reason that they’re delivering more than one type of mRNA. Will the BA.4/BA.5 mRNA have different effects? Will they cause cross-reactions? Who knows? There’s no data. At bare minimum, if the adverse effects of the original shots are an indication, there’s every reason to suspect the bivalent boosters will be just as dangerous.

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