COVID-19 Vaccines and Children

COVID-19 vaccines and children is a highly controversial topic for many reasons. For simplicity, children here are defined as those persons under 18 years of age. The arguments for vaccinating youth are generally similar among those under 18 years of age, though there exists some variation in the risk profile within this age group. Where necessary, those arguments are separated by more specific age classes.

Risk-Benefit Analysis

  • Feb 7, 2022 - Claim: Pfizer Covid-19 Vaccine increases Children’s risk of Death by 5100% according to the Office for National Statistics.1)
  • February 20, 2022 - in a blog post, Stats Jamie shows how “it would take around four million vaccine doses to two million children [aged 5-11] to prevent one admission to ICU”.2)

Proposed Justifications for Vaccinating Youth

Johns Hopkins Medicine encouraged “all families to have eligible children vaccinated with the COVID-19 vaccine”3) and provided five benefits as justification of this decision:

  1. The vaccine helps prevent kids from getting COVID-19
  2. The vaccine helps prevent or reduce the spread of COVID-19
  3. Getting vaccinated for COVID-19 can help stop other variants from emerging
  4. Having your child vaccinated for COVID can help restore a more normal life
  5. COVID-19 vaccines help protect the community

The data in support and in opposition to each of these claims is evaluated below to understand the strength of the benefits in the risk-benefit analysis of vaccinating youth against COVID-19.

1. The vaccine helps prevent kids from getting COVID-19

There are four metrics to evaluate within this claim: the efficacy of vaccines in preventing 1) cases 2) symptomatic cases 3) hospitalization cases and 4) deaths.

2. The vaccine helps prevent or reduce the spread of COVID-19

[data here]

3. Getting vaccinated for COVID-19 can help stop other variants from emerging

There is no evidence that vaccines protect against the emergence of novel virus variants. A 2015 study illustrated one potential mechanism under which leaky vaccines enhance the transmission of virulent pathogens.4)

4. Having your child vaccinated for COVID can help restore a more normal life

The notion of needing to “restore a more normal life” rests on the premise that an emergency is ongoing. While COVID-19 does pose a threat to some populations, children are not among them. As stated by the Canadian Academics for Covid Ethics, the emergency as passed. In battling COVID-19, “we won. We should be celebrating and resuming life, not vaccinating children, a group for whom the threat of COVID-19 never constituted an emergency.”5)

5. COVID-19 vaccines help protect the community

[data here]

Opposition to COVID-19 Vaccines for Children

Dr. Steven Pelech of the Canadian Covid Care Alliance submitted a petition to the House of Commons demanding a halt to COVID-19 vaccinations for children, pregnant women and young adults of childbearing age, sponsored by Member of Provincial Parliament (MPP) Dean Allison.6) 7) 8) It finished on January 6, 2022 with 33,083 signatures.9)

COVID-19 Risk Profiles of Children

Children have suffered far lower rates of COVID-19 illness during the SARS-CoV-2 pandemic.

https://docs.google.com/document/d/12Qu5qpPbR4xzcRzIdC-dwSmytC6-T03djrdxMKBQ4Es/edit#

Children and COVID mortality https://www.medrxiv.org/content/10.1101/2021.07.01.21259785v1 https://www.bmj.com/content/370/bmj.m3249 “The CDC’s MMWR in Sept or Dec 2020 published an article about the kids who had died from Covid. I blogged about it. There were roughly 100, and CDC claimed 3/4 of them had preexisting conditions.

Risk of Hospitalization, severe disease, and mortality due to COVID-19 and PIMS-TS in children with SARS-CoV-2 infection in Germany https://www.medrxiv.org/content/10.1101/2021.11.30.21267048v1.full.pdf

So I wonder where Makary got his data.

There have been two papers I am aware of published about pedi hospitalizations from Covid at two pedi hospitals in CA. In one paper, 4 kids died, all of whom had severe preexisting conditions. Perhaps that is what he was referring to. “ https://www.cdc.gov/mmwr/volumes/70/wr/mm7023e1.htm “admitted during January 1–March 31, 2021, and hospitalization rates (hospitalizations per 100,000 persons) among adolescents during March 1, 2020–April 24, 2021. Among 204 adolescents who were likely hospitalized primarily for COVID-19 during January 1–March 31, 2021, 31.4% were admitted to an intensive care unit (ICU), and 4.9% required invasive mechanical ventilation; there were no associated deaths.” Estimation, what? https://www.cdc.gov/mmwr/volumes/70/wr/mm7042e1.htm

Authorizations for COVID-19 Vaccines in Children

Pfizer Vaccine Approved for US Children 5-11 Years Old

On November 2, 2021, the Pfizer-BioNTech Covid vaccine was approved by the CDC, after the agency’s Advisory Committee on Immunization Practices (ACIP) favored the move in a unanimous vote (14-0).10) This action came four days after the FDA granted emergency use authorization of the vaccine in ages as young as five.11) About 28 million children in this age group reside in the US. The ongoing clinical trial (C4591007), conducted on about 3,100 children, administered a dose of 10 micrograms, followed by the same dose 21 days later. The BNT162b2 vaccine for 5-11 year-olds was administered at 1/3 the dose of the 12 years and older vaccine. Interestingly, the 5-11 year-old vaccine was also reformulated after the trial assessment was performed, to “improve stability”, per the FDA Briefing Document provided by Pfizer on Oct. 26, 2021. The phosphate-buffered saline (PBS) has been removed, as have the sodium chloride and potassium chloride. In their place, PfizerBioNTech uses tromethamine (aka TRIS) buffer.12) The vials of BNT162b have a bright orange cap, to distinguish them from the adult vaccine, and each one provides 10 doses, once diluted with 1.3mL of .9% sodium chloride. 13)

14 ACIP Members Who Voted to Jab Your Young Children — and Their Big Ties to Big Pharma

On Nov. 2, members of the CDC Centers for Disease Control and Prevention’s vaccine advisory committee voted 14–0 to recommend Pfizer’s pediatric COVID shot for children 5 –11 years old.

Committee members readily voted “yes” despite many unknowns about long-term safety, including a complete lack of data on the risk of heart problems like the ones experienced by some adolescents who received COVID vaccines.

Neither the disgracefully unscientific vote nor CDC Director Rochelle Walensky’s prompt endorsement came as a surprise. Though billed as “independent,” the 14 ACIP members — like the 17 members of FDA’s VRBPAC who voted the same way the previous week — have deep ties to pharma, with careers that hinge on promoting and rubber-stamping the United States’ destructive one-size-fits-all vaccination agenda.

Describing the VRBPAC and ACIP meetings as “a total sham,” Children’s Health Defense President Mary Holland said, “Sadly, approval from these committees means nothing in terms of safety.”

https://childrenshealthdefense.org/defender/cdc-acip-pfizer-pediatric-covid-vaccine-big-pharma/

Pfizer Vaccine Approved for British Children 5-11 Years Old

On December 22, 2021, the UK health regulator quietly announced that “A new paediatric formulation of the Pfizer BioNTech COVID-19 vaccine has been approved for children aged 5 to 11 after meeting the required safety, quality and effectiveness standards.”

COVID-19 Vaccine Adverse Event Risks in Children

Cardiac Adverse Event Risks

An analysis of reports filed with the Vaccine Adverse Event Reporting System (VAERS) of adolescents ages 12-17 who received mRNA vaccination against COVID-19 between January 1, 2021 and June 18, 2021 found that these adverse events exceed their expected 120-day COVID-19 hospitalization rate at both moderate (August 21, 2021 rates) and high COVID-19 hospitalization incidence.14)

In response to increasing rates of youth cardiac injury, multiple jurisdictions including in Ontario, Canada and Norway, released guidance on managing myocarditis and pericarditis in youth post-Pfizer and Moderna vaccination.15) 16) 17)

Myocarditis

Pediatric myocarditis symptoms can be mild or as extreme as sudden cardiac arrest. Early identification of the severity of illness and timely provision of critical care is helpful; however, the risk factors associated with mortality remain unclear and controversial.18) Clinical outcomes to avoid early mortality after onset of myocarditis involves urgent procedures such heart transplant and immunosuppression.19)

Periocarditis

Mortality

Risk Benefit Analysis of COVID-19 Vaccines in Children

Given that the risks of COVID-19 in children are relatively low, COVID-19 vaccines fail to provide sterile immunity, vaccine efficacy is in question, and these vaccines seem to result in an array of deadly and potential deadly adverse events, there seems to be a starkly negative risk-benefit associated with vaccinating children.20)

A July 6, 2021 study affirmed that mild or even asymptomatic infection with SARS-CoV-2 results in “durable neutralizing antibody responses in children and adolescents.”21)

In a letter to the BMJ in July, 2021, a Danish professor, Christine S Benn, from the University of Southern Denmark, wrote to the BMJ questioning the policy of vaccinating children. The letter is heavily referenced.

In a Substack post by Corey Mitchell, dated December 9, 2021 and called Comprehensive Risk/Benefit Analysis for Administering COVID-19 Vaccines to Children, Mitchell points out that, in the US, there were 200 total deaths involving COVID-19 for age group 5-14 as of November 27, 2021 (compared to 334 for pneumonia over the same time period), demonstrating the virus presents a virtually zero risk to healthy children.

Politics Surrounding COVID-19 Vaccines for Children

Rigged votes in FDA/CDC hearings?

NEJM - Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

Emmanuel B. Walter, M.D., Kawsar R. Talaat, M.D., Charu Sabharwal, M.D., M.P.H., Alejandra Gurtman, M.D., Stephen Lockhart, D.M., Grant C. Paulsen, M.D., Elizabeth D. Barnett, M.D., Flor M. Muñoz, M.D., Yvonne Maldonado, M.D., Barbara A. Pahud, M.D., M.P.H., Joseph B. Domachowske, M.D., Eric A.F. Simões, M.B., B.S., D.C.H., M.D., Uzma N. Sarwar, M.D., Nicholas Kitchin, M.D., Luke Cunliffe, B.Sc., Pablo Rojo, M.D., Ernest Kuchar, M.D., Ph.D., Mika Rämet, M.D., Ph.D., Iona Munjal, M.D., John L. Perez, M.D., M.A., Robert W. Frenck, Jr., M.D., Eleni Lagkadinou, M.D., Ph.D., Kena A. Swanson, Ph.D., Hua Ma, Ph.D., Xia Xu, Ph.D., Kenneth Koury, Ph.D., Susan Mather, M.D., Todd J. Belanger, M.S., David Cooper, Ph.D., Özlem Türeci, M.D., Philip R. Dormitzer, M.D., Ph.D., Uğur Şahin, M.D., Kathrin U. Jansen, Ph.D., and William C. Gruber, M.D. for the C4591007 Clinical Trial Group 22)

Background

Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age.

Methods

A phase 1, dose-finding study and an ongoing phase 2–3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2–3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed. Results

During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2–3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3). Conclusions

A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643. opens in new tab.)23)

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children and Young Adults

DISCLAIMER - The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.24)

  • How Are Participants Protected?
  • Informed consent is a process used by researchers to provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document before joining a study to show that he or she was given information on the risks, potential benefits, and alternatives and that he or she understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over. See the Questions to Ask section on this page for questions to ask a health care provider or researcher about participating in a clinical study.
  • Institutional review boards. Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community. Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other responsibilities. The IRB also reviews the informed consent document.
  • In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards).
  • Various Federal agencies, including the Office of Human Subjects Research Protection and FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.

Brief Summary; This is a Phase 1/2/3 study in healthy children and young adults.

Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants <6 months of age may subsequently be evaluated.

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at; URL Pfizer link last active 2017. 25)26)

RBA by el gato malo (steel-man's the case for vaccinating kids): https://boriquagato.substack.com/p/pfizer-says-their-covid-vaccine-works?

10 Red Flags by Toby Rogers (raises some glaring statistical problems with FDA/Pfizer's RBA): https://tobyrogers.substack.com/p/ten-red-flags-in-the-fdas-risk-benefit

Matthew Memoli (NIH) gave presentation on Dec. 1 during NIH's Grand Rounds, arguing against vaccine mandates because only elderly have a clearly positive risk-benefit ratio. Good support from “credible,” NIH source. https://www.campfire.wiki/doku.php?id=matthew_memoli

https://www.euronews.com/next/2021/09/14/covid-vaccine-for-children-who-in-europe-is-leading-the-race https://twitter.com/dontcensorme21/status/1455708319826550784?s=20

PFIZER AND BIONTECH RECEIVE FIRST U.S. FDA EMERGENCY USE AUTHORIZATION OF A COVID-19 VACCINE IN CHILDREN AGES 5 THROUGH 11 YEARS

Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years

From CDC Provisional COVID-19 Deaths: Focus on Ages 0-18 Years

Covid-19 and Vaccination Risks in Children A Resource for Parents

S K, [04.11.21 13:39] <500 C19 deaths in 5-18 age group. Which is almost certainly inflated

Connor Charchuk, [04.11.21 13:40] Yeah all the data I've found (and what appears to be what the FDA based this decision on) is state data which is reported as 0-17 years or 0-19 years - nothing about 5-11 years specifically.

S K, [04.11.21 13:41] [In reply to Connor Charchuk] CDC provisional I liked above is 5-18

S K, [04.11.21 13:42] And 0-4

Connor Charchuk, [04.11.21 13:43] Is there similar data for cases and hospitalizations?

Brian, [04.11.21 13:43] [In reply to Connor Charchuk] https://tobyrogers.substack.com/p/what-is-the-number-needed-to-vaccinate

Brian, [04.11.21 13:44] [In reply to S K] 173 in the 5-11 age group have died From COVID according to the CDC

S K, [04.11.21 13:45] [In reply to Connor Charchuk] Maybe, but I haven’t seen it. I would think there’s some kind of provisional data that the CDC queue rates for that. The question of data integrity is pretty serious with all that though. The definition of a case really depends on when the testing was done and by whom

Andrew, [04.11.21 13:47] Of course the risk is inflated. 86-92% of pediatric hospitalizations are NOT for COVID. They simply test positive during screening while being hospitalized for something else. https://hosppeds.aappublications.org/content/11/8/e159

Andrew, [04.11.21 13:47] “For COVID” or “With COVID”: Classification of SARS-CoV-2 Hospitalizations in Children https://pubmed.ncbi.nlm.nih.gov/34011566/ Northern California. “reported hospitalization rates likely lead to overestimation of the true disease burden.”

Andrew, [04.11.21 13:47] Characteristics of Hospitalized Children Positive for SARS-CoV-2: Experience of a Large Center https://pubmed.ncbi.nlm.nih.gov/34011567/ “Most hospitalized patients who test positive for SARS-CoV-2 are asymptomatic or have a reason for hospitalization other than coronavirus disease 2019. ”

Cody Porter, [04.11.21 13:55] Ugh. One day I'm going to stop being surprised by how blatant they are.

Cody Porter, [04.11.21 13:55] https://www.fda.gov/media/150386/download

Cody Porter, [04.11.21 13:56] Midway through page 8 and into page 9

Cody Porter, [04.11.21 13:56] Pfizer doesn't make any comirnaty

Cody Porter, [04.11.21 13:57] Therefore there's no “available alternative” to their EUA vaccine

Diane linked to the FDA briefing document above, but I feel it needs a prominent place on this page. Link to document: https://www.fda.gov/media/153447/download. Risk Benefit analysis begins on page 32. The following can be found on pg 33: “Under Scenario 3 (lowest incidence), the model predicts more excess hospitalizations due to vaccine-related myocarditis/pericarditis compared to prevented hospitalizations due to COVID-19 in males and in both sexes combined.” This is taken out of context, so read carefully, but it is an important statement, as long as context is observed.

Great Britain: Excess Mortality Among Children After Vaccine Rollout

https://alternative-hypothesis.com/covid19-vaccine-adverse-effects-uncertainty

5)
Andrée, A., PhD, Capurri, V., PhD, Chaufan, C., Chow, C., C. Dir. ,. DBA, MBA, MSc, B(Eng), CFA, Christian, C., DPhil, de Ruiter, A., PhD, Durante, A., PhD, Forte, M. C., PhD, Francis, D., PhD, RN, Graham, J., BA, MA, PhD, Leduc, L., PhD, Price, R., PhD, Rancourt, D., PhD, Rinner, C., PhD, Turan, M., PhD, BCBA, & Canadian Academics for Covid Ethics. (2021, November 24). Five facts all parents should know about the mRNA vaccines. Troy Media. Retrieved November 26, 2021, from https://troymedia.com/health/five-facts-all-parents-should-know-about-the-mrna-vaccines/
6)
Sturgess, W. (2021, December 11). Petition to Halt COVID-19 Vaccines for Children, Pregnant Women, Young Adults. Canadian Covid Care Alliance. https://archive.ph/IwWYI
7)
Pelech, S. (2021, December 7). Petition e-3696. Parliament of Canada. https://archive.ph/E6eSh
8)
Walia, A. (2021, December 21). UBC Immunologist Petitions Canadian Government To Stop COVID-19 Vaccination. The Pulse. https://web.archive.org/web/20211224185304/https://thepulse.one/2021/12/21/ubc-immunologist-petitions-canadian-government-to-stop-covid-19-vaccination/
9)
Pelech, S. (2022, January 6). Petition e-3696 - Petitions. House of Commons; Parliament of Canada. https://archive.ph/0NQ8m
14)
Høeg, T. B., Krug, A., Stevenson, J., & Mandrola, J. (2021). SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12–17: A Stratified National Database Analysis. medRxiv. Preprint. https://doi.org/10.1101/2021.08.30.21262866
15)
Groves, H. (2021, August 6). Myocarditis and pericarditis after mRNA COVID-19 vaccination in children: Interim guidance. SickKids. Retrieved November 17, 2021, from https://www.sickkids.ca/contentassets/50c1bd3c95e74dcf9fa7c9f6fd707bd7/interim-guidance_myocarditis-pericarditis-after-mrna-covid-19-vaccination-in-children.pdf
16)
Ontario Agency for Health Protection and Promotion. (2021). Myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in Ontario: December 13, 2020 to September 4, 2021. Public Health Ontario. https://www.publichealthontario.ca/-/media/documents/ncov/epi/covid-19-myocarditis-pericarditis-vaccines-epi.pdf?sc_lang=en
17)
Myocarditis in boys and young men can occur more often after the Spikevax vaccine from Moderna. (2021, June 10). Norwegian Institute of Public Health. https://www.fhi.no/en/news/2021/myocarditis-in-boys-and-young-men-can-occur-more-often-after-the-spikevax-v/
18)
Chang, Y.-J., Hsiao, H.-J., Hsia, S.-H., Lin, J.-J., Hwang, M.-S., Chung, H.-T., Chen, C.-L., Huang, Y.-C., & Tsai, M.-H. (2019). Analysis of clinical parameters and echocardiography as predictors of fatal pediatric myocarditis. PLOS ONE, 14(3), e0214087. https://doi.org/10.1371/journal.pone.0214087
19)
Lee KJ, McCrindle BW, Bohn DJ, Wilson GJ, Taylor GP, Freedom RM, et al. Clinical outcomes of acute myocarditis in childhood. Heart 1999; 82: 226–233. pmid:10409542
20)
Abi-Jaoude, E., & Doshi, P. (2021, July 13). Covid-19 vaccines for children: hypothetical benefits to adults do not outweigh risks to children. The BMJ. Retrieved November 24, 2021, from https://blogs.bmj.com/bmj/2021/07/13/covid-19-vaccines-for-children-hypothetical-benefits-to-adults-do-not-outweigh-risks-to-children/
21)
Garrido, C., Hurst, J. H., Lorang, C. G., Aquino, J. N., Rodriguez, J., Pfeiffer, T. S., Singh, T., Semmes, E. C., Lugo, D. J., Rotta, A. T., Turner, N. A., Burke, T. W., McClain, M. T., Petzold, E. A., Permar, S. R., Moody, M. A., Woods, C. W., Kelly, M. S., & Fouda, G. G. (2021). Asymptomatic or mild symptomatic SARS-CoV-2 infection elicits durable neutralizing antibody responses in children and adolescents. JCI Insight, 6(17). https://doi.org/10.1172/jci.insight.150909
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