Restore Trust

To Legislators:

RESTORE TRUST IN PUBLIC HEALTH POLICIES: TRACK PRODUCT INJURIES NOT PRODUCT UPTAKE

OPPOSE:

H.R. 2527 Vaccinate All Children Act of 2019

H.R. 2862 Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act 

S.1619 Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act

S. 1895 Public Awareness Campaign on the Importance of Vaccination (Part of large bill titledthe Lower Health Care Costs Act)

WHY OPPOSE:

The bills do nothing to enhance the safety of the nation, rather they perpetuate the dangerous current state of immunizations policies which fail to recognize a) the actual capabilities, limitations, and unintended consequences of vaccine products; b) the need for personal medical decisions regarding any medical intervention—no pharmaceutical product line, including vaccines, are one size fits all; c) the growing distrust in Public Health Agencies which work in official collaboration with pharmaceutical companies.

“Vaccine hesitancy” has been thoroughly researched. A Pubmed[i]search of the term “vaccine hesitancy” retrieves more than 600 published papers, including many which found that those labeled “hesitant” or “refusers” are actually far more knowledgeable about vaccines than those who unquestioningly follow the CDC schedule. These parents know the science and history of vaccines and the infections they target. They know that the decline of infectious disease fatalities was shown to be due to clean water, improved sanitation, and better living conditions, as acknowledged by CDC scientists in 2000, in the Journal of Pediatrics: 

“Thus vaccination does not account for the impressive declines in mortality seen in the first half of the century…nearly 90% of the decline in infectious disease mortality among US children occurred before 1940, when few antibiotics or vaccines were available.”[ii]

The CDC is unable to honestly and accurately support the claim that vaccines are safe for both short-term andlong-term health; the data is not even being collected. The existing passive Vaccine Adverse Event Reporting System (VAERS) captures less than 1% of adverse events recorded In medical records[iii].

Whooping cough and mumps are breaking out in fully-vaccinated populations, and CDC’s own 2007 study estimated 1/3 of all fully-vaccinated 26 year-olds are susceptible to measles. Current vaccine products are incapable of protecting the immune-compromised. Between primary failure (never develop immunity), secondary failure (waning immunity), tertiary failure (strain replacement/mutation) and poor design (symptoms suppressed temporarily but infection & transmission not prevented)—the promised artificially-induced “herd” immunity simply cannot happen, not even with 100% vaccination rates. Clean water is safe and effective for all and should be mandated. Vaccines are not equally safe and effective for everyone and should never be mandated.

The first step toward restoring public faith in Public Health Policy, after striking the term “vaccine hesitancy” and the derogatory “anti-vaxxer” from the vernacular, is to address the major problems with public health policies and programs:

  • Mandate an automated vaccine adverse event reporting system as modeled in the CDC-funded Harvard-Pilgrim Study[iv]and give independent researchers access to the data
  • Implement a Practitioner & Public Awareness Campaign on the importance of recognizing and reporting vaccine adverse reactions to improve vaccine safety.
  • Restore market safety incentives: Repeal 1986 NCVIA and eliminate all vaccination incentives/rewards/awards
  • Eliminate the corporate capture of Public Health – Separate Pharma and State

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TWENTY PROBLEMS WITH VACCINE SCIENCE

by Alvin H. Moss, MD, FACP, FAAHPM*

  1. No placebo-controlled studies with saline injection as the placebo[v],[vi],[vii],[viii]
  2. Short duration of follow-up (as little as days to weeks)[ix],[x],[xi]
  3. Sixty percent of vaccines contain aluminum, but there are no human or animal studies involving SC or IM injections of aluminum to establish the safety of injecting infants and children with aluminum hydroxide, aluminum phosphate or amorphous aluminum hydroxyphosphate sulfate.[xii],[xiii]
  4. One-size-fits-all. Newborns have 20% of the kidney function of a 2 year old[xiv](excretion of aluminum through the kidneys is the main route to remove systemic aluminum) yet both receive the same dose of aluminum-containing vaccines; the one-size-fits-all approach is in stark contrast to precision medicine, an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.[xv]
  5. No safety studies on the entire vaccine schedule;[xvi],[xvii]Institute of Medicine (IOM) recommended studies which have not been done.IOM noted, “…studies designed to examine the long-term effects of the cumulative number of vaccines or other aspects of the immunization schedule have not been conducted.”12
  6. Monitoring largely for pre-specified and solicited adverse events in clinical trials leading to vaccine approval[xviii]
  7. No active post-marketing surveillance (Vaccine Adverse Events Reporting System is passive and voluntary)[xix]
  8. No vaccinated versus unvaccinated studies by CDC to learn true adverse events of vaccines12
  9. No research to identify those with preexisting susceptibilities to vaccine injury[xx]
  10. Small sample sizes in clinical trials that do not allow detection of less frequent severe adverse events compounded by underreporting in voluntary, passive post-market surveillance.14,[xxi]
  11. No incentive to improve vaccine safety because vaccine makers cannot be sued (and consequently no changes to improve safety in a particular vaccine during the 17-year life of the patent)[xxii]
  12. Underreporting of vaccine injuries—less than 1% (Harvard 2010 study)—so no good way to assess balance of benefits versus harms17,[xxiii]
  13. No studies for carcinogenicity, mutagenicity and impairment of fertility[xxiv]
  14. No adequate research base to evaluate vaccine safety—Institute of Medicine concluded there was insufficient science to accept or reject a causal relationship for 135 adverse events reported with vaccines—“The absence of evidence is not the same as evidence of absence.” IOM 2012 report, Adverse Effects of Vaccines: Evidence and Causality.15
  15. Excessive reliance on observational retrospective studies in which confounding variables cannot be examined (weak science).[xxv],[xxvi]
  16. No accounting for healthy user bias in observational retrospective and prospective studies.22,[xxvii]
  17. Scientific misconduct in which there is selective or misleading reporting of data or omission of conflicting data to arrive at a desired conclusion[xxviii],[xxix],[xxx],[xxxi]
  18. Scientific misconduct in which there is deceptive reporting of results to omit important limitations to generalizability of results (e.g., vaccination status of groups are not comparable) or in which groups are deceptively misrepresented as “unvaccinated” when they had received a number of vaccines[xxxii],[xxxiii]
  19. Conflicts of interest of those conducting the studies (“investigator determined that deaths associated with vaccine were not vaccine-related”; no Data Safety Monitoring Boards) and those approving the vaccines (Advisory Committee on Immunization Practices)[xxxiv],[xxxv]
  20. No safety testing of vaccines and vaccine ingredients in pregnant women even though CDC recommends vaccines to pregnant women[xxxvi]

*Dr. Moss has more than 40 years of medical practice, research, and teaching experience. His interest in vaccine safety and vaccine injury was first prompted by ethical concerns regarding conflicts of interest in vaccine research and in public policy. The opinions expressed here are his own and do not represent those of his employer.


[i]PubMed is an online resource developed and maintained by the National Center for Biotechnology Information (NCBI)at the National Library of Medicine® (NLM).

[ii]http://vaccinesafetycommission.org/pdfs/45-2000-Pediatrics-Vital-Statistics.pdf

[iii]https://healthit.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf

[iv]https://healthit.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf

[v]https://gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Boostrix/pdf/BOOSTRIX.PDF

[vi]https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert—Adacel.pdf

[vii]https://www.fda.gov/media/75195/download

[viii]See the package inserts for the remaining childhood vaccines under 6.1 Clinical Trials experience

[ix]https://www.fda.gov/media/79341/download

[x]https://www.fda.gov/media/79341/download

[xi]https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm124514.pdf    

[xii]https://www.ncbi.nlm.nih.gov/pubmed/29307441

[xiii]https://www.sciencedirect.com/science/article/pii/S0946672X19304201?via%3Dihub

[xiv]https://www.ncbi.nlm.nih.gov/pubmed/22555478

[xv]https://ghr.nlm.nih.gov/primer/precisionmedicine/definition

[xvi]https://www.nap.edu/read/13563/chapter/2#5

[xvii]https://www.ncbi.nlm.nih.gov/pubmed/26830300

[xviii]See Section 6.1 Clinical Trials in vaccine package inserts

[xix]https://www.ncbi.nlm.nih.gov/pubmed/23063829

[xx]http://nationalacademies.org/hmd/Reports/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality.aspx

[xxi]https://www.ncbi.nlm.nih.gov/pubmed/23597717

[xxii]https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3393829

[xxiii]https://healthit.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf

[xxiv]See Section 13.1 in vaccine package inserts

[xxv]https://www.sciencedirect.com/science/article/pii/S0040595718302464

[xxvi]https://journals.sagepub.com/doi/full/10.1177/0141076815596690

[xxvii]https://www.ncbi.nlm.nih.gov/pubmed/21203857

[xxviii]https://www.ncbi.nlm.nih.gov/pubmed/23682040

[xxix]https://www.ncbi.nlm.nih.gov/pubmed/20388211

[xxx]https://www.ncbi.nlm.nih.gov/pubmed/30249615

[xxxi]https://www.ncbi.nlm.nih.gov/pubmed/27649528

[xxxii]https://academic.oup.com/jpids/advance-article/doi/10.1093/jpids/piz010/5372494

[xxxiii]https://www.ncbi.nlm.nih.gov/pubmed/30831578

[xxxiv]http://vaccinesafetycommission.org/pdfs/Conflicts-Govt-Reform.pdf

[xxxv]https://oig.hhs.gov/oei/reports/oei-04-07-00260.pdf

[xxxvi]See Section 8.1 Pregnancy in vaccine package inserts