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FDA, CDC Green Light Pfizer’s Experimental COVID Biologic for Children 5 to 11 Years Old

child getting vaccinated

One Oct 29, 2021, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the experimental messenger RNA (mRNA) Pfizer/BioNTech COVID-19 biologic BNT162b2 for children five to 11 years old. The FDA’s decision, which is based on a clinical trial earlier this year involving 2,268 kindergartners and elementary school-aged kids and an ongoing trial involving more than 4,600 participants, comes two weeks after the Biden administration outlined plans to begin administering the biologic to children in this age range against COVID.1 2 3

FDA Uses Modeling to Predict If Giving Pfizer COVID Shots to Young Children is Worth the Potential Risks

In a press release, the FDA stated:

The FDA has determined this Pfizer vaccine has met the criteria for emergency use authorization. Based on the totality of scientific evidence available, the known and potential benefits of the Pfizer/BioNTech COVID-19 vaccine in individuals down to five years of age outweigh the known and potential risks.1 2

The FDA noted that the potential risks include “increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with Pfizer/BioNTech COVID-19 Vaccine, particularly following the second dose, and with the observed risk highest in males 12 through 17 years of age.”2 According to the FDA, the agency legally responsible for licensing drugs and biological products distributed in the U.S., it has…

conducted its own benefit-risk assessment using modeling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine in children five through 11 years of age would prevent versus the number of potential myocarditis cases, hospitalizations, ICU admissions and deaths that the vaccine might cause.2

The FDA’s model “predicts that, overall, the benefits of the vaccine would outweigh its risks in children five through 11 years of age.”2

The Pfizer/BioNTech COVID shot for children aged five to 11 years old would be administered in two doses 21 days apart, which is the same regimen used for those 12 years and older. The dosage, however, would be two-thirds smaller—10 μg (micrograms) rather than the 30 μg given to older children and adults.1 2 3

CDC Committee Gives Unanimous Approval to Give Pfizer COVID Shots to Children 5 to 11 Years Old

The FDA’s EUA approval was followed on Nov. 2 by a unanimous recommendation (14-0 vote) by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) to administer Pfizer/BioNTech COVID biologic to all children five to 11 years of age—a total of about 28 million children in the United States. The recommendation was endorsed later that day by CDC director Rochelle Walensky, MD.4 5 6 7

According to Jeff Zients, the White House Coronavirus Response Coordinator, the program to give children five to 11 years old the Pfizer/BioNTech biologic will begin in earnest this week. “Parents will be able to schedule appointments at convenient sites they know and trust to get their kids vaccinated. And the number of sites will continue to increase throughout the month as more vaccine sites open their doors and administer vaccine, “Zients said.5 6


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Click here to view References:

1 Barrabi T. FDA approves Pfizer vaccine for emergency use in children aged 5 to 11. Fox Business Oct. 29, 2021.
2 Press release. FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age. U.S. Food and Drug Administration Oct 29, 2021.
3 TVR Staff. White House Reveals Plans to Give COVID Shots to All 5 to 11 Year Old Children. The Vaccine Reaction Oct. 25, 2021.
4 Associated Press. CDC gives final approval for Pfizer’s COVID shot for kids 5-11. MarketWatch Nov. 2,2 021.
5 Branswell H. CDC advisers endorse Pfizer’s Covid-19 vaccine for kids 5-11. STAT Nov. 2, 2021.
6 McKenna J. ACIP Recommends Pfizer-BioNTech Covid-19 Vax for Kids Ages 5-11. Physician’s Weekly Nov. 3, 2021.
7 Press release. CDC Recommends Pediatric COVID-19 Vaccine for Children 5 to 11 Years. U.S. Centers for Disease Control and Prevention Nov. 2, 2021.

35 Responses

  1. How sad that NVIC is not telling the truth here and warning parents. Is it because you believe you will lose your funding? Why republish what the FDA and the criminals behind these deadly shots are saying here? What is the purpose of this publication? Are you now receiving funding from the pharmaceutical industry? Has someone paid you or threatened you to be quiet, like they did to Joe Mercola?

    The blood of these children will be on your hands also.

    1. Uhhhhhhhhh………… TruthSpeaker, Im Totally with you on this one!!! Like where is the REST of the story, you know the part where the NVIC refutes these awful measures with their own Scientific, unbiased Commentary??? This is kinda suspicious and I hope it was an oversight, but we must remain vigilant on keeping an eye on this- Peace

    2. Get triggered. Then go off the page on the public boards by not understanding the very basic principals of this NVIC group, their funding, and their methods. Go to NVIC.org to learn more.

    3. please tell more about what NVIC and dr. Mercola … what’s going on.. Please.. I have supported NVIC and Mercola for over 10 yrs.. what did I miss.. need sources as to where you are getting this information… I am a TRUTHER.. no matter what… the TRUTH is always FIRST with me… thank you

    4. Hi there….so, I’m relatively new to this site, and don’t understand why this article was put on this platform…is “the vaccine reaction” just putting EVERYTHING regarding new authoritarian mandates, etc., out for us all to see IN ADDITION TO the adverse effects, the (actual) truth in regards to the (non)vaccines as well?

      Is this publication sharing both sides of the proverbial coin or has it truly sold out?

      1. Ultimately, Parents are responsible for their children, so why are parents not protecting their children. There have been books out there for years, to read, on this subject matter.
        Just look at the “non-nutritional” food in baskets at the grocery store. How many times do your children eat Fast Food, because adults are too busy to cook fresh foods. What goes through that tube from the mouth to the anus of your child? Really, do you not realize the pressure these folks that are trying to protect children are under, when it is the Parents role.

  2. One thing is for certain and rarely mentioned….more and more adults in authority over us regarding these vaccines….do not have children.
    May God give parents the wisdom and the courage to refuse these experimental injections.

  3. Doctors and parents should be ashamed of themselves to allow this to happen to children and healthy adults as well. It’s especially true when the so-called virus has never been seen in a lab or tested on animals and even at age 80, has a 99% cure rate with simple supplements and/or Ivermectin or Hydroxychloroquine.

  4. The operative word is experimental. I do not want to be a component of an unnecessary experiment and I do not want any child to be one either. I feel like we have been invaded by the body snatchers or in the lab of mad scientists, which we are, or we are being led by the Pied Piper, or by satan himself. Adults stand a better chance of survival, their brains and organs are fully developed, a huge percentage have already given birth to the children they wanted, a large percent have already lived full,healthy lives. A lot of parents are making the decision to vaccinate their children because they did not experience any significant side effects from the vaccine, but, they must factor in future side effects.

  5. Some logic challenges are in order.

    How do people think these companies are so good and adept at; manipulating safety studies, consistently proving their pharmaceutical products safe and effective despite most follow up analysis proving otherwise, obtaining consistent fast tracks to approval, having so much clout to push a never ending series of legislative actions seeking to compel people to consume their products, burying criticism, intimidating professionals into silence, intimidating parents, denying people basic access, and so on and so forth.

    Because these pharmaceutical companies have been manipulating safety study data and spending more on marketing than research for longer than most of us have been alive.

    “I’m not against vaccines, but am not for THIS vaccine.” Logical fault.

    There really is only 3% of the population holding this line. Those whom refused to vaccinate their children. How does one not realize that the falsified safety data is not limited to this one product? These are ongoing events, and well oiled falsification methods.

    Learn to say no on principal. Good ideas do not require force. One does not need to even pick a side. Simply wait until any given product or idea stands the test of time and scrutiny, before participating. If the government would have done absolutely nothing we’d be past this by now. People are dying from medical malpractice, which is why before the vaccine hit, they primarily only died in hospitals. Now the vaccines are killing them by priming them to be unable to resist basic illness. This is masterful data manipulation and propaganda.

    “To deny natural immunity is to deny the very basis for vaccination.” That’s going viral.

    Just like all the other hundreds of thousands of product recalls in the past, they’ll be unpacking covid issues for the next decade. That’s too long to wait, we opted out on principal. Problem solved. All medical products are safe and effective when they’re making billions of dollars. How do people not see through this fraud?

    https://www.federalregister.gov/documents/2021/11/05/2021-23643/covid-19-vaccination-and-testing-emergency-temporary-standard
    Tell me they put that together in a single month…

    https://www.law.com/texaslawyer/2021/10/14/texas-joins-montana-in-banning-private-employer-covid-19-vaccine-mandates/?slreturn=20211008153441
    Stay aware of legislative rules regarding discrimination based on vaccine status.

  6. Uhhhhhhhhh………… TruthSpeaker, Im Totally with you on this one!!! Like where is the REST of the story, you know the part where the NVIC refutes these awful measures with their own Scientific, unbiased Commentary??? This is kinda suspicious and I hope it was an oversight, but we must remain vigilant on keeping an eye on this- Peace

  7. The committee that approved this latest
    all have ties to Pfizer in one way or another.. Talk about biases…This approval is criminal as far as I am concerned. Time to protest the results because of this??????

  8. Once Pandora’s box has been opened, how can we stop the damage & future unknown consequences? It’s truly unconscionable how we’re being manipulated!! Juanita

  9. Uhhhhhhhhhhhhhh……. Where is the REST of the story???? Like how you REFUTE THESE BIASED CLAIMS AND THE POISONOUS implementation of jabs in our PRECIOUS LITTLE ONES BODIES???? Hope this was just an oversight, as Im sure it was, because this just does not seem like you to re-publish whats already out there WITHOUT ANY REBUTTAL whatsoever-

  10. These organizations are full of ex or future big pHarma executives. Consistently. We have seen how useless ACIP is. We have seen hours of people sharing horrendous recollections of negative experiences including death of loved ones. The members do not even look at the people. Then after gut wrenching painful testimony they do what they are likely paid to do with cash or promises, and they vote affirmative to use a dangerous product. Totally discarding the factual traumas presented. It is obvious who is calling the shots, literally and figuratively.

    1. https://childrenshealthdefense.org/defender/fda-pfizer-covid-kids-pharma/
      11/01/21
      17 Pharma Henchmen Who Voted to Experiment on Your Kids — and How to Shun Them
      The 17 members of the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee who voted 17-0 in favor of authorizing Pfizer’s COVID vaccine for kids ages 5 to 11 all have deep ties to pharma.
      By Children’s Health Defense Team

      https://dossier.substack.com/p/the-revolving-door-all-3-fda-authorized
      The Revolving Door: All 3 FDA-authorized COVID shot companies now employ former FDA commissioners
      System of corruption.
      Jordan Schachtel
      Oct 16

      https://theexpose.uk/2021/11/01/pfizer-adds-ingredient-to-vaccine-for-kids-that-treats-heart-attacks/
      Why has Pfizer changed the formulation of its Covid-19 Vaccine for Children to include an ingredient that stabilises people suffering a Heart Attack?
      BY THE EXPOSÉ ON NOVEMBER 1, 2021

      https://tobyrogers.substack.com/p/the-fdas-use-of-temporary-voting
      The FDA’s use of Temporary Voting Members is corrupt, unscientific, and an affront to democratic norms
      Toby Rogers
      Oct 23

      https://tobyrogers.substack.com/p/ten-red-flags-in-the-fdas-risk-benefit
      Ten red flags in the FDA’s risk-benefit analysis of Pfizer’s EUA application to inject American children 5 to 11 with its mRNA product
      The FDA briefing document is preposterous junk science and it must be withdrawn immediately
      Toby Rogers
      Oct 25

  11. Don’t know why someone would castigate TVR for publishing a dry, non-partisan, non-judgmental, non-biased article which simply states some facts about what the FDA and the WH have done. Most of us are smart enough to find all the biased articles we could desire to read. Most of us.

  12. So how is it in the UK there are now more covid (?) deaths and serious hospitalised injuries of those who have had two shots of the toxic chemical pathogen devices than those who did not take the failed injections. When are you traitor Pharma owned agencies going to stop the Clinical trials of this experimental pathogen which now has the worst clinical trial record in the entire world. If the Globalist Pharma Agencies around the world were not so afraid of losing their Pharma donations this disastrous trial would have been stopped a long while ago. Even the Pharma want the feeding frenzy to continue otherwise in previous times they would have stopped their trials with just a few deaths and sae’s now one wonders if they are an important and key part of the Globalist genocide. The Ceo and Boards must be very confident they will get the Globalists full protection from any consequences of their actions.

  13. After replying/commenting my confusion regarding the rational for posting this article, and not understanding the WHY, in addition to reading some comments that initially led me to believe that perhaps this publication supported this articles’ content….I was definitely CONFUSED!

    I then read the mission statement, which publishes BOTH SIDES so that an INFORMED decision can be made by the readers, and to keep the readers informed of what is indeed what is being authorized by the government. Important especially if you choose not to get sucked into TV.

    I can only hope that folks “wake up” and May God help all of the innocent children from a NON-vaccine that children don’t even need. (To me this is a real life nightmare!)

  14. I have always appreciated NVIC because they present the FACTS in an unbiased manner and let the reader form his/her own opinion. That’s what I see is being done here. We know where NVIC stands on the issue, but that is not conveyed in their reporting of the facts.

  15. I don’t know that this article is an instance of selling out – I think that having access to the exact verbiage of what the FDA is publishing as their basis for recommending the vaccine is what is important here. This is because these exact words will NOT generally be quoted or published by the media. This article seeks to show that even though a very small and recent study has been done with actual children on short term side effects (which most of us here would likely say in itself is highly inadequate), that the FDA is recommending this vaccine for children based on “predictions” via models done by their own idea of “risk-assessment,” rather than actual data. To me, that’s what’s important in this article.

  16. Kerala, approximately 35 million people, 28 day count (from Johns Hopkins) 220,705 cases 7458 deaths. mRNA

    Uttar Pradesh approximately 240 million people 28 day count (from Johns Hopkins) 250 cases and 7 deaths. Early treatment protocol with home kit.

    Each home kit contained the following: Paracetamol tablets [tylenol], Vitamin C, Multivitamin, Zinc, Vitamin D3, Ivermectin 12 mg [quantity #10 tablets], Doxycycline 100 mg [quantity #10 tablets]. Other non-medication components included face masks, sanitizer, gloves and alcohol wipes, a digital thermometer, and a pulse oximeter.

  17. I’m not an advocate either way, I am pro vaccine, when there is a real vaccine that prevents infection.

    This is some interesting information gleaned today from JHU to share, simply the case counts.

    JHU does not tell what the difference is, but the trace and home kit information that Uttar Pradesh is using is readily available with a search. (Not the mainstream search engine)

    Kerala, approximately 35 million people, 28 day count (from John’s Hopkins) 220,705 cases 7458 deaths. mRNA

    Uttar Pradesh approximately 240 million people 28 day count (from John’s Hopkins) 250 cases and 7 deaths. Early treatment protocol with home kit.

  18. Here in NZ, govt has purchased Pfizer 5-11 yr awaiting FDA approval. Govt and workplaces are starting to role out mandatory vaccinations for most jobs and venues like concerts. A small minority are holding back. It’s getting tough here. I too have been watching the UK. I know they had AstraZeneca, did they have Pfizer too?

  19. We know wat CDC, FDA say so do not need to hear this. Where’s the rest of the story? I had hoped for better on your site.

  20. With 70% of the US population vaccinated, and a better than 99% survival rate if you’re not vaccinated, why are the ‘powers that be’ trying to do forced vaccinations on everyone? Where are all these millions of people that have already had Covid, either knowingly or having been asymptomatic, being accounted for? I would like to have an HONEST accounting of how many in the medical/scientific community that are truly ‘in the know’ about Covid have actually gotten the jabs. And I am not talking about people unable to think for themselves. People really in the know.

  21. Someone asked about animal testing…..from what I understand a veterinary student stated on a national television program this year that when they tested animals with the m rna all the animals died.

  22. October 24, 2021 Child Deaths Are 52% Higher than the 5-year-average Since They Were Offered the COVID-19 Vaccine, after Previously Being 14% Down According to ONS Data

    New data published by the Office for National Statistics has revealed that the number of children to have died since Chris Whitty advised the Government they should be offered the Covid-19 vaccine is 52% higher than the five-year-average, after previously being 14% down on the five-year-average up until the Joint Committee on Vaccination and Immunisation being overruled.

    https://theexpose.uk/2021/10/20/child-deaths-are-52-percent-higher-since-they-were-offered-the-covid-19-vaccine/

  23. To you people who are trashing NVIC for not standing up for use and offering an apposing view, Truethspeaker, Tim and a few others.
    It is clear that you must be new to this site and know absolutely nothing about the hard work and dedication that NVIC puts forth on a daily basis to help keep government Bills that are harmful to your health and your liberties from being past.
    If you are a true follower of NVIC you already know their stand on this issue.

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