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--- covid-19_vaccines:children [2022/02/08 20:32]
pamela
+++ covid-19_vaccines:children [2022/09/30 17:36] (current)
dennis [Risk-Benefit Analysis]
@@ Line 1: / Line 1: @@
 ====== 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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 === 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.
+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.