S.827 - National Childhood Vaccine Improvement Act of 1986 H.R.5546 - National Childhood Vaccine Injury Act of 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 Program Requirements - **Establishes the National Vaccine Injury Compensation Program as an alternative remedy to judicial action** for specified [[vaccine-related injuries

Prescribes the contents of any petition for compensation.

Grants U.S. district courts authority to determine eligibility and compensation Requires the district court in which the petition is filed to designate a special master to serve as an adjunct to the court. Sets forth the responsibilities of the court.

Lists factors to be considered when determining the amount of a compensation award. Sets forth a table of injuries deemed vaccine-related for compensation purposes Permits the Secretary of Health and Human Services to: (1) promulgate regulations to revise such table; and (2) recommend changes to the vaccines covered by the table.

Provides that compensation awarded under the Program shall be paid out of the National Vaccine Injury Compensation Trust Fund Limits awards for actual and projected pain and suffering and emotional distress to $250,000. Prohibits awards for punitive damages

Establishes the Advisory Commission on Childhood Vaccines to: (1) advise the Secretary on the implementation of the Program; (2) recommend changes to the Vaccine Injury Table; and (3) recommend research priorities.

Part B: Additional Remedies - Sets forth procedures under which the person who filed a petition for compensation under the program may elect to file a civil action for damages

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.

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 the Secretary to develop certain vaccine information materials for distribution to the legal representatives of any child receiving a vaccine listed in the Vaccine Injury Table. Directs the Secretary to promote the development of safer childhood vaccines.

Sets forth record keeping and reporting requirements for vaccine manufacturers. Imposes civil and criminal penalties for destroying, altering, or concealing any such report or record. Part D: General Provisions - Allows any person to commence a civil action against the Secretary where the Secretary allegedly has failed to perform a duty under this Act. Provides for judicial review of the Secretary's regulatory actions in a court of appeals of the United States.

Allows the Secretary to provide licensing for unpatented vaccines for naturally occurring human infectious diseases under certain circumstances.

Requires the Secretary to conduct studies on pertussis, rubella, and radiculoneuritis vaccines and publish the results of such studies.

Directs the Secretary to study the risks to children associated with each vaccine listed in the Vaccine Injury Table and establish guidelines respecting the administration of such vaccines. Directs the Secretary to periodically review and revise such guidelines.

Directs the Secretary to review the warnings, use instructions, and precautionary information presently used by manufacturers of vaccines listed in the Vaccine Injury Table. Directs the Secretary to require manufacturers to revise and reissue any warning, instruction, or information found inadequate.

Grants the Secretary recall authority with respect to any licensed virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other licensed product which presents a danger to public health. Establishes civil penalties for recall violations.

Directs the Secretary to make annual reports to specified congressional committees on the impact this Act has on the supply of vaccines.

Title II: Miscellaneous - Provides that certain Federal provisions designed to reduce paperwork shall not apply to information required to carry out this Act

https://www.congress.gov/bill/99th-congress/house-bill/5546

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

*National Childhood Vaccine Injury Act*

During the mid-1970s, there was an increased focus on personal health and more people became concerned about vaccine safety. Several *lawsuits were filed against vaccine manufacturers* and healthcare providers by people who believed they had been injured by the diphtheria, pertussis, tetanus (DPT) vaccine. Damages were awarded despite the lack of scientific evidence to support vaccine injury claims. [4] As a result of these decisions, liability and prices soared, and several vaccine manufacturers halted production. A vaccine shortage resulted and public health officials became concerned about the return of epidemic disease. To reduce liability and respond to public health concerns, Congress passed the National Childhood Vaccine Injury Act NCVIA in 1986.

The National Vaccine Program Office (NVPO) was established to coordinate immunization-related activities between all Department of Health and Human Services (DHHS) agencies including the Centers for Disease Control and Prevention CDC, Food and Drug Administration FDA National Institutes of Health NIH, and the Health Resources and Services Administration HRSA

The NCVIA requires health care providers who administer vaccines to provide a vaccine information statement (VIS) to the person getting the vaccine or his or her guardian. A VIS must be given with every vaccination including each dose in a multi-dose series Each VIS contains a brief description of the disease as well as the risks and benefits of the vaccine. CDC develops VISs and distributes them to state and local health departments as well as individual providers.

The NCVIA also requires health care providers to report certain adverse events (health effects occurring after immunization that may or may not be related to the vaccine) following vaccination to the Vaccine Adverse Event Reporting System VAERS

Under the NCVIA, the National Vaccine Injury Compensation Program (NVICP) was created to compensate those injured by vaccines on a “no fault” basis.

The NCVIA established a committee from the Institute of Medicine (IOM) to review the literature on vaccine reactions. This group concluded that there are limitations in our knowledge of the risks associated with vaccines. The group looked at 76 health problems to see if they were caused by vaccines. Of those, 50 (66%) had no or inadequate research to form a conclusion.

*Specifically, the IOM identified the following problems:*

1. Limited understanding of biological processes that underlie adverse events. 2. Incomplete and inconsistent information from individual reports. 3. Poorly constructed research studies (not enough people enrolled for the period of time). 4. Inadequate systems to track vaccine side effects. 5. Few experimental studies were published in the medical literature.

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.

After the vaccine completes these laboratory tests successfully, the FDA approves its use in clinical studies on human subjects. Participation in these studies is completely voluntary.Volunteers agree to receive the vaccine and undergo any medical testing necessary to assess its safety and efficacy.

Vaccine licensing is a lengthy process that may take 10 years or longer. The FDA requires that vaccines undergo three phases of clinical trials with human subjects before they can be licensed for use in the general public:

Phase one trials are small,involving only 20 to 100 volunteers, and last only a few months. The purpose of phase one trials is to evaluate basic safety and identify very common reactions.

Phase two trials are larger and involve several hundred participants. These studies last anywhere from several months to two years and collect additional information on safety and efficacy. Data gained from phase two trials can be used to determine the composition of the vaccine, how many doses are necessary, and a profile of common reactions.

Unless the vaccine is ineffective or causes health problems, the trials are expanded to Phase three trials, which involves several hundred to several thousand volunteers. Typically these trials last several years. Because the vaccinated group can be compared to those who have not received the vaccine, researchers are able to identify true reactions

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

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 vaccine lot must be tested because vaccines are sensitive to environmental factors like temperature, and can be contaminated during production.

While clinical trials provide important information on vaccine safety, the data are somewhat limited because of the relatively small number (hundreds to thousands) of study participants. Rare side effects and delayed reactions may not be evident until the vaccine is administered to millions of people. Therefore, the federal government established a surveillance system to monitor adverse events following vaccination. This project is known as the Vaccine Adverse Event Reporting System VAERS In addition, large-linked databases containing information on millions of individuals have been created to study rare vaccine adverse events.

https://web.archive.org/web/20150902133540/https://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html

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

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.