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--- covid-19_vaccines:children [2022/01/10 03:01]
liam [Opposition to COVID-19 Vaccines for Children]
+++ covid-19_vaccines:children [2022/09/30 17:36] (current)
dennis [Risk-Benefit Analysis]
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 ====== COVID-19 Vaccines and Children ======
-{{:covid-19_vaccines:kidsvaccinespic.jpeg?200 |}}
+{{ :covid-19_vaccines:kidsvaccinespic.jpeg?200|}}
+**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.((February 7, 2022 | [[:The Expose]] | [[https://dailyexpose.uk/2022/02/07/covid-vaccinated-children-5100-percent-more-likely-to-die/|Pfizer Covid-19 Vaccine increases Children’s risk of Death by 5100% according to the Office for National Statistics]]))
+  * 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".((https://www.statsjamie.co.uk/4-million-doses-in-children-needed-to-prevent-1-icu-admission/))
+  * The FDA did its own analysis that tried to compare the risk of vaccine myocarditis versus the risk of hospitalization or death from infection on page 34 [[https://www.fda.gov/media/153447/download|Vaccines and Related Biological Products Advisory Committee Meeting-October 26, 2021]]. One can glean from this a Number Needed to Vaccinate to save one child's life at 1 million, so 2 million shots.  One could then go further and wonder how many close calls with anaphylactic shock before the vaccines actually cost more lives than they save for this age group.  Not sure if natural immunity from natural infection was included in their calculations or not.
+{{:covid-19_vaccines:nntvfdakids.png?400|}}
-**COVID-19 vaccines and children** is a highly controversial topic for many reasons. For simplicity, child here is defined as those <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.
 ===== Proposed Justifications for Vaccinating Youth =====
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 ===== 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]].((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)) ((Pelech, S. (2021, December 7). //Petition e-3696.// Parliament of Canada. https://archive.ph/E6eSh)) ((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/))
+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]].((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)) ((Pelech, S. (2021, December 7). //Petition e-3696.// Parliament of Canada. https://archive.ph/E6eSh)) ((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/)) It finished on January 6, 2022 with 33,083 signatures.((Pelech, S. (2022, January 6). //Petition e-3696 - Petitions.// House of Commons; Parliament of Canada. https://archive.ph/0NQ8m))
 ===== COVID-19 Risk Profiles of Children =====
@@ Line 115: / Line 122: @@
 ==== 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
+((https://web.archive.org/web/20220208002155/https://www.nejm.org/doi/full/10.1056/NEJMoa2116298))
+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.)((https://web.archive.org/web/20220130143341/http://clinicaltrials.gov/ct2/show/NCT04816643))
+=== 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.((https://web.archive.org/web/20220130215938/https://clinicaltrials.gov/ct2/about-studies/learn#Considerations))
+  * 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. ((https://web.archive.org/web/20170624123250/https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests | Pfizer link last active 2017))((https://web.archive.org/web/20220130143341/http://clinicaltrials.gov/ct2/show/NCT04816643))
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