FDA Approval of Vaccines

Health
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FDA Approval of Vaccines and Manufacturer Liability

Purpose

This policy outlines the conditions under which vaccines may receive FDA approval, emphasizing the importance of comprehensive testing for interactions among vaccines, addressing manufacturer liability, and mandating reporting of adverse reactions.

Background

The landscape of vaccination has dramatically changed since 1986, evolving from 7 routine vaccine injections to over 200 by 2025. This increase raises concerns about safety, efficacy, and the potential risks associated with multiple vaccines administered simultaneously.

Policy Statements

1. FDA Approval Contingency

  • All vaccines seeking FDA approval must undergo rigorous testing to evaluate their interactions with other currently approved vaccines. This includes:
    • Clinical trials that specifically assess the safety and efficacy of the vaccine in combination with other approved vaccines.
    • Comprehensive studies on potential adverse reactions when administered concurrently with other vaccines.

2. Manufacturer Liability

  • Vaccine manufacturers shall maintain liability for any injuries or adverse reactions resulting from Excipients used in their vaccines. This includes:
    • Accountability for long-term side effects that may arise post-approval.
    • Requirement for manufacturers to provide funding for independent research on vaccine safety and efficacy.
    • No liability waiver for extra DNA or Excipients! These are the other ingredients in vaccines that are added for specific purposes. These include:
      Preservatives: Prevent contamination. For example, thimerosal.
      Adjuvants: Stimulate a stronger immune response. For example, aluminum salts.
      Stabilizers: Keep the vaccine potent during storage and transportation. For example, gelatin or sugars.
      Inactivating ingredients: Kill viruses or inactivate toxins. For example, mercury formaldehyde.
      Antibiotics: Prevent contamination by bacteria. For example, neomycin.
      Cell culture materials: Used to grow the vaccine antigens. For example, egg protein or various culture media.

3. Monitoring and Reporting

  • Establish a robust post-marketing surveillance system to monitor adverse events following vaccination. This system should:
    • Collect and analyze data on adverse reactions, with a focus on those occurring in conjunction with other vaccines.
    • All immune response disorders shall be assumed to be caused by vaccination unless disproven by other scientifically recognized causes such as organ transplant.
    • Ensure all adverse reactions or suspected adverse reactions are reported to the Vaccine Adverse Event Reporting System (VAERS) within 90 days of occurrence.
    • Ensure transparency by publicly reporting findings to healthcare providers and the public.

4. Public Education

  • Develop educational programs to inform healthcare providers and the public about the benefits and risks associated with the expanded vaccination schedule. This initiative should:
    • Highlight the importance of understanding vaccine interactions and the necessity of informed consent.
    • Provide resources to help individuals make educated decisions regarding vaccination.

5. Regular Review and Update

  • The CDC’s vaccination schedule shall be reviewed regularly, with adjustments made based on emerging research regarding vaccine interactions and safety. This process should involve:
    • Collaboration with independent experts and stakeholders in the field of immunization.
    • Continuous evaluation of the public health impacts of the vaccination schedule.

6. Patient Vaccination Rate Collection and Use

Insurance companies are prohibited from adjusting doctor and medical payment based on vaccination rates of patients.
Pharmaceutical companies are prohibited from adjusting doctor and medical costs based on vaccination rates of patients.

Conclusion

This policy aims to ensure that the increasing complexity of vaccination schedules is met with stringent safety measures and accountability from manufacturers. By requiring thorough testing of vaccine interactions, maintaining liability for manufacturers, and mandating timely reporting of adverse reactions to VAERS, we can foster a safer immunization environment for all individuals across their lifespan.

1 Like
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The foundation of this proposal is disturbing, in that it seems to assume that appropriate testing on currently approved vaccines has been done.

Sometime in the spring or summer of 2024, a court hearing produced an acknowledgement from an agency - I think CDC rather than FDA - acknowledged that they had not responded to ICAN FOIA requests because they had zero data supporting their assertion that autism is not caused by vaccines given during the first year of life. In a July 6, '24 letter to the editor of New England Journal of Medicine, the authors detoured around admitting that they have been lying to the public and the medical profession for the past 40 years by instead bemoaning the lack of funding to perform appropriate pre- and post- approval studies.

Other data suggests that at least some “safety studies” have used already approved vaccines as the “placebo”. As a potential customer, the question being asked in such a case avoids asking what I really want to know.

I believe there is no vaccine for which the followup interval has exceeded six months, and that case is the outlier. If a vaccine is anticipated to have an effect on the body for a number of years - if not decades, then the followup needs to extend to a somewhat proportional interval. Many disorders are known to take years to develop. Some are difficult to diagnose and take years to be identified.

Unfortunately, I think every vaccine on the market needs to be more closely examined, including the aspects suggested in this policy proposal.

Before we vaccuum the carpet, we will need clear the dirt underneath.

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Vaccines must be evaluted against a true placebo like pure saline. Currently then are not. Independent study evaluations must be done to eliminate poorly constructed studies, studies which have been tampered with, studies whose abstracts or conclusions are inconsistent with the study itself. Vaccines must be evaluated for safety for extended periods of time and a need must exist for the vaccine. A vaccine must be proved better than no vaccine at all. Natural immunity must be acknowledged. Physician experience with patient outcomes must be taken into account.

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Actually if the new interactions testing is to focus on only one specific vaccine but it must be tested with each of the already 200 approved vaccines they will need to test them as well to be able to to say those side affects are from 151 not 210. It’s a back door to get the testing done that’s should have been done initially.

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We must also make public officials who approve or mandate products for use in humans financially and criminally responsible for the results.

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