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vaccine_law_and_lawbreaking [2021/11/12 20:48]
cody 		vaccine_law_and_lawbreaking [2021/12/18 13:45] (current)
pamela
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-[[National Childhood Vaccine Injury Act of 1986]]+====National Childhood Vaccine Injury Act of 1986====
  
  
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 99th Congress (1985-1986) 99th Congress (1985-1986)
  
-National Childhood Vaccine Injury Act of 1986 - Title I: Vaccines - Subtitle 1: [[National Vaccine Program]] - Amends the Public Health Service Act to establish in the Department of Health and Human Services a National Vaccine Program to: (1) direct vaccine research and development within the Federal Government; (2) ensure the production and procurement of [[safe and effective vaccines[[; (3) direct the distribution and use of vaccines; and (4) coordinate governmental and nongovernmental activities ...+[[National Childhood Vaccine Injury Act of 1986]] - Title I: Vaccines - Subtitle 1: [[National Vaccine Program]] - Amends the Public Health Service Act to establish in the Department of Health and Human Services a National Vaccine Program to: (1) direct vaccine research and development within the Federal Government; (2) ensure the production and procurement of [[safe and effective vaccines[[; (3) direct the distribution and use of vaccines; and (4) coordinate governmental and nongovernmental activities ...
  
 Title I: Vaccines - Subtitle 1: National Vaccine Program - Amends the Public Health Service Act to establish in the Department of Health and Human Services a National Vaccine Program to: (1) direct vaccine research and development within the Federal Government; (2) ensure the production and procurement of safe and effective vaccines; (3) direct the distribution and use of vaccines; and (4) coordinate governmental and nongovernmental activities. Requires the Director of the Program to report to specified congressional committees. Title I: Vaccines - Subtitle 1: National Vaccine Program - Amends the Public Health Service Act to establish in the Department of Health and Human Services a National Vaccine Program to: (1) direct vaccine research and development within the Federal Government; (2) ensure the production and procurement of safe and effective vaccines; (3) direct the distribution and use of vaccines; and (4) coordinate governmental and nongovernmental activities. Requires the Director of the Program to report to specified congressional committees.
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 **Provides that no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death**: (1) resulting from **unavoidable side effects; or (2) solely due to the manufacturer's failure to provide direct warnings. Provides that a manufacturer may be held liable where: (1) such manufacturer engaged in the fraudulent or intentional withholding of information; or (2) such manufacturer failed to exercise due care. Permits punitive damages in such civil actions under certain circumstances.** **Provides that no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death**: (1) resulting from **unavoidable side effects; or (2) solely due to the manufacturer's failure to provide direct warnings. Provides that a manufacturer may be held liable where: (1) such manufacturer engaged in the fraudulent or intentional withholding of information; or (2) such manufacturer failed to exercise due care. Permits punitive damages in such civil actions under certain circumstances.**
  
-===Part C: Assuring a Safer Childhood Vaccination Program=== in the United States +====Part C: Assuring a Safer Childhood Vaccination Program in the United States====  
  
 Requires each health care provider who administers a vaccine listed in the [[Vaccine Injury Table]] to record certain information with respect to each such vaccine. Requires each health care provider and vaccine manufacturer to report certain information to the Secretary.//  Requires each health care provider who administers a vaccine listed in the [[Vaccine Injury Table]] to record certain information with respect to each such vaccine. Requires each health care provider and vaccine manufacturer to report certain information to the Secretary.// 
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 https://www.congress.gov/bill/99th-congress/house-bill/5546 https://www.congress.gov/bill/99th-congress/house-bill/5546
  
-===CDC Vaccine Safety and Law===+====CDC Vaccine Safety and Law====
  
 To ensure the continued success of vaccines in the United States, it’s crucial to make sure that vaccines are safe.  Before vaccines are approved by the Food and Drug Administration [[FDA]], they are tested extensively by scientists to ensure they are effective and safe To ensure the continued success of vaccines in the United States, it’s crucial to make sure that vaccines are safe.  Before vaccines are approved by the Food and Drug Administration [[FDA]], they are tested extensively by scientists to ensure they are effective and safe
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 ***Specifically, the IOM identified the following problems:*** ***Specifically, the IOM identified the following problems:***
  
-   1. Limited understanding of biological processes that underlie adverse events. +1. Limited understanding of biological processes that underlie adverse events. 
-   2. Incomplete and inconsistent information from individual reports. +2. Incomplete and inconsistent information from individual reports. 
-   3. Poorly constructed research studies (not enough people enrolled for the period of time). +3. Poorly constructed research studies (not enough people enrolled for the period of time). 
-   4. Inadequate systems to track vaccine side effects. +4. Inadequate systems to track vaccine side effects. 
-   5. Few experimental studies were published in the medical literature. +5. Few experimental studies were published in the medical literature. 
        
        
-===Monitoring Vaccine Safety: Pre-Licensure===+====Monitoring Vaccine Safety: Pre-Licensure====
  
 Before vaccines are licensed by the FDA, they are **tested extensively** in the laboratory and with human subjects to ensure their safety. First, researchers use computers to predict how the vaccine will interact with the human immune system. Then researchers test the vaccine on animals including mice, guinea pigs, rabbits, and monkeys.   Before vaccines are licensed by the FDA, they are **tested extensively** in the laboratory and with human subjects to ensure their safety. First, researchers use computers to predict how the vaccine will interact with the human immune system. Then researchers test the vaccine on animals including mice, guinea pigs, rabbits, and monkeys.  
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 **If the clinical trials demonstrate that the vaccine is safe and effective** the manufacturer applies to the FDA for two licenses: one for the vaccine (product license), and one for the production plant (establishment license). During the application process, the [[FDA]] reviews the **clinical trial data** and proposed product labeling. In addition, the FDA inspects the plant and goes over manufacturing protocols to ensure vaccines are produced in a safe and consistent manner. Only after the FDA is satisfied that the vaccine is safe is it licensed for use in the general population    **If the clinical trials demonstrate that the vaccine is safe and effective** the manufacturer applies to the FDA for two licenses: one for the vaccine (product license), and one for the production plant (establishment license). During the application process, the [[FDA]] reviews the **clinical trial data** and proposed product labeling. In addition, the FDA inspects the plant and goes over manufacturing protocols to ensure vaccines are produced in a safe and consistent manner. Only after the FDA is satisfied that the vaccine is safe is it licensed for use in the general population   
  
-===Monitoring Vaccine Safety: Post-Licensing===+====Monitoring Vaccine Safety: Post-Licensing====
  
 After a vaccine is licensed for public use, its safety is monitored continually. The FDA requires all manufacturers to submit samples from each vaccine lot prior to its release. In addition, the manufacturers must provide the FDA with their test results for vaccine safety, potency, and purity. Each lot must be tested because vaccines are sensitive to environmental factors like temperature, and can be contaminated during production. The FDA rarely has recalled vaccine lots, for concerns such as mislabeling, contamination during production, and potential manufacturing problems at a production plant.  After a vaccine is licensed for public use, its safety is monitored continually. The FDA requires all manufacturers to submit samples from each vaccine lot prior to its release. In addition, the manufacturers must provide the FDA with their test results for vaccine safety, potency, and purity. Each lot must be tested because vaccines are sensitive to environmental factors like temperature, and can be contaminated during production. The FDA rarely has recalled vaccine lots, for concerns such as mislabeling, contamination during production, and potential manufacturing problems at a production plant. 
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 https://web.archive.org/web/20150902133540/https://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html https://web.archive.org/web/20150902133540/https://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html
 +
 +
 +=== FDA Lawsuits ===
 +
 +FDA Produces the First 91+ pages of Documents from Pfizer’s COVID-19 Vaccine File by Aaron Siri
 +
 +Two months and one day after it was sued, and close to 3 months since it licensed Pfizer’s Covid-19 vaccine, the FDA released the first round of documents it reviewed before licensing this product.  The production consisted of 91 pdf pages, one xpt file, and one txt file. You can download them here.
 +
 +While it is for the scientists to properly analyze, let me share one observation.  One of the documents produced is a Cumulative Analysis of [[Post-Authorization Adverse Event Reports]] of [the Vaccine] Received Through 28-Feb-2021, which is a mere 2 ½ months after the vaccine received emergency use authorization (EUA).  This document reflects adverse events following vaccination that have completed Pfizer’s “workflow cycle,” both in and outside the U.S., up to February 28, 2021.
 +
 +Pfizer explains, on page 6, that ***“Due to the large numbers of spontaneous adverse event reports received for the product, [Pfizer] has prioritised the processing of serious cases…”*** and that Pfizer “has also taken a [sic] multiple actions to help alleviate the large increase of adverse event reports” including “increasing the number of data entry and case processing colleagues” and “has onboarded approximately [REDACTED] additional fulltime employees (FTEs).”  Query why it is proprietary to share how many people Pfizer had to hire to track all of the adverse events being reported shortly after launching its product.
 +
 +As for the volume of reports, **in the 2 ½ months following EUA, Pfizer received a total of 42,086 reports containing 158,893 “events.”**  Most of these reports were from the U.S. and disproportionately involved women (29,914 vs. 9,182 provided by men) and those between 31 and 50 years old (13,886 vs 21,325 for all other age groups combined, with another 6,876 whose ages were unknown).  Also, 25,957 of the events were classified as “Nervous system disorders”
 +
 +Females between the ages of 30 and 51. Nervous system disorders. That sounds familiar.  As a matter of fact, that sounds similar to the concerns raised by some of the women testifying or described in the videos below.
 +
 +But no cause for alarm since Pfizer explains to the FDA: “The findings of these signal detection analyses are consistent with the known safety profile of the vaccine.”  So if they knew these issues were going to arise, then why didn’t they appear to have enough staff to process this expected volume of reports?  The grand conclusion by Pfizer to the FDA: “The data do not reveal any novel safety concerns or risks requiring label changes and support a favorable benefit risk profile of to the BNT162b2 vaccine.” 
 +
 +Nothing to see here.  Just ask all those women. (more...)
 +
 +https://aaronsiri.substack.com/p/fda-produces-the-first-91-pages-of
 +
 +https://phmpt.org/wp-content/uploads/2021/10/001-Complaint-101021.pdf
 +
 +
 +===== Vaccine Mandate Lawsuits =====
 +
 +2021 December 13 - [[Boeing]] and [[Raytheon]] employees filed suit in federal court in North Alabama against the federal contractor. The suit challenges the employers' vaccine mandate policies. On Tuesday, Being received notice of the complaint. Boeing announced that it is SUSPENDING its unlawful mandate policies. 
 +
 +The lawsuits are:
 +
 +Case 5:21-cv-01646-LCB Document 1 Filed 12/13/21 Page 1 of 28 FILED IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ALABAMA
 +
 +JAMES LIEBBE, RYAN MING, ) HUNTER QUINLAN, NICHOLAS ) HOGAN, BLAKE JOHNSON, ) RUSSELL OWEN, and TIM TODD, Plaintiffs, v. SAFER FEDERAL WORKFORCE TASK FORCE; KIRAN AHUJA, in her official capacity as co-chair of the Safer Federal Workforce Task Force and the director of the Office of Personnel Management; ROBIN CARNAHAN, in her official capacity as co-chair of the Safer Federal Workforce Task Force and Administrator of the General Services Administration; and JEFFREY ZIENTS, in his official capacity as a co-chair of the Safer Federal Workforce Task Force and COVID-19 Response Coordinator; THE BOEING COMPANY, and RAYTHEON TECHNOLOGIES, Defendants.
 +
 +AND:
 +
 +Case 5:21-cv-01668-HNJ Document 1 Filed 12/16/21 Page 1 of 25 FILED IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ALABAMA
 +
 +MICHAEL ZMUDA, KYLE ) BRICKHOUSE, DONAL DOHERTY, ) LESLIE DYER, CHRIS HENKE, ) ROBERT HALOWAY, SEAN ) MARTIN, KYLE MURPHREE, ) JONATHAN REINER, THEODORE ) STROUP, JEANA RUPP, ) v. LLOYD AUSTIN, III, in his official capacity as Secretary of Defense, U.S. Department of Defense, Defendant.
 +
 +COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF LUCILLE PONIATOWSKI, MICHAEL STEELMAN, and RICHARD SZCEPANSKI, Plaintiffs, v. LLOYD AUSTIN, III, in his official capacity as Secretary of Defense, U.S. [[Department of Defense]], Defendant.
  
  
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