by Maura Urchek BSN, RN, CCM

Have you noticed advertisements in recent years promoting vaccination in Ohio? Perhaps you have seen a television commercial or heard an in-store advertisement soliciting you to undergo the medical procedure of vaccination and wondered, is it possible that there is more to the story that vaccine consumers might like to know beyond, “get vaccinated,” before rolling up their sleeves?  

Consider the following information: 

• As a result of the 1986 National Childhood Vaccine Injury Act, Congress granted vaccine manufacturers and vaccine administrators protection from liability for injury caused by select [1] vaccine products: “No person may bring a civil action … against a vaccine administrator or manufacturer in a State or Federal court for damages arising from a vaccine-related injury or death.” [2]
  
• Who pays for vaccine injury if manufacturers are not liable? The Health Resources & Services Administration (HRSA) states the following: “The Vaccine Injury Compensation Trust Fund provides funding for the National Vaccine Injury Compensation Program to compensate vaccine-related injury or death petitions for covered vaccines administered on or after October 1, 1988. Funded by a $.75 excise tax on vaccines recommended by the Centers for Disease Control and Prevention for routine administration to children, the excise tax is imposed on each dose … The Department of Treasury collects the excise taxes and manages the Fund’s investments and produces Vaccine Injury Compensation Trust Fund Monthly Reports.” [3]
• According to the Health Resources & Services Administration (HRSA) National Vaccine Injury Compensation Program (NVICP) website:“The National Vaccine Injury Compensation Program is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions." [4]  The NVICP has paid out over $4.2 billion to date [5], as of the October 1, 2019 report. 
• If an individual becomes injured by vaccination and wishes to file a petition with the NVICP, how much time do they have to file a claim? The US Department of Health & Human Services Health Resources and Services Administration’s publication booklet: “What You Need to Know About the National Vaccine Injury Compensation Program” [6] states the following: “The general filing deadlines are:  For an injury, your claim must be filed within 3 years after the first symptom of the vaccine injury.  For a death, your claim must be filed within 2 years of the death and 4 years after the start of first symptom of the vaccine-related injury from which the death occurred. When a new vaccine is covered by the VICP or when a new injury/condition is added to the Vaccine Injury Table, claims that do not meet the general filing deadlines must be filed within 2 years from the date the vaccine or injury/condition is added to the Table for injuries or deaths that occurred up to 8 years before the Table change. The Table lists and explains injuries that are presumed to be caused by vaccines. For more details about the Table, visit www.hrsa.gov/vaccinecompensation.” 
• According to the HRSA website, “National Vaccine Injury Compensation Program - Frequently Asked Questions”: “The Vaccine Injury Table (Table) (PDF - 119 KB) is a listing of covered vaccines and associated injuries that makes it easier for some people to get compensation. The Table lists and explains injuries and/or conditions that are presumed to be caused by vaccines unless another cause is proven.” [7]
• Vaccine injuries are to be reported to the Vaccine Adverse Event Reporting System (VAERS) [8]. According to the “Information for Healthcare Providers” section of the VAERS website:“The National Childhood Vaccine Injury Act (NCVIA) requires healthcare providers to report: Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine; or Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination [PDF - 75KB] that occurs within the specified time period after vaccination. In addition, CDC encourages you to report any clinically significant adverse event that occurs in a patient following a vaccination, even if you are unsure whether a vaccine caused the event.” [9]
• According to a Grant Report submitted to the Agency for Healthcare Research and Quality, Electronic Support for Public Health–Vaccine Adverse Event Reporting System [10]:“Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed. Barriers to reporting include a lack of clinician awareness, uncertainty about when and what to report, as well as the burdens of reporting: reporting is not part of clinicians’ usual workflow, takes time, and is duplicative.” [11]
• The Vaccine Excipients Summary is accessible as a PDF file download here. According to the summary document, certain vaccines may contain: MRC-5 human diploid cells including DNA and protein (human fetus origin),  Madin Darby Canine Kidney (MDCK) cell protein (cocker spaniel dog origin), formaldehyde, Spodoptera frugiperda cell proteins (armyworm origin), thimerosal (a mercury derivative), aluminum hydroxide, amorphous aluminum hydroxyphosphate sulfate, among many other excipients with potentially serious ethical, scientific, and religious implications for consumers. The US FDA website, “Common Ingredients in U.S. Licensed Vaccines” reveals the following: “How does FDA evaluate adjuvants for safety and efficacy? When evaluating a vaccine for safety and efficacy, FDA considers adjuvants as a component of the vaccine; they are not licensed separately.” [12]
• The CDC website, “Advisory Committee on Immunization Practices (ACIP) -- General Committee-Related Information” states:“The Advisory Committee on Immunization Practices (ACIP) comprises medical and public health experts who develop recommendations on the use of vaccines in the civilian population of the United States. The recommendations stand as public health guidance for safe use of vaccines and related biological products.” [13] Consider the following excerpt from the 2009 article published in the New York Times titled, “Advisers on Vaccines Often Have Conflicts, Report Says”: “In the report, expected to be released Friday, Daniel R. Levinson, the inspector general of the Department of Health and Human Services, found that the centers failed nearly every time to ensure that the experts adequately filled out forms confirming they were not being paid by companies with an interest in their decisions. The report found that 64 percent of the advisers had potential conflicts of interest that were never identified or were left unresolved by the centers. Thirteen percent failed to have an appropriate conflicts form on file at the agency at all, which should have barred their participation in the meetings entirely, Mr. Levinson found. And 3 percent voted on matters that ethics officers had already barred them from considering.” [14]

Awareness of the NVICP, VAERS, ACIP, and NCVIA is critical to understanding vaccine policy, vaccine manufacturer protections, and vaccine consumer risk in the United States.   

A recent public records request revealed the following invoices from 2016, 2017, 2018, and 2019:

2019BTS- Invoice SP1684.pdf

2018DTaP - Invoice SP1579.pdf

2018BTS - Invoice SP1598.pdf

2018Adol-Meningitis - Invoice SP1584.pdf

2018-19Influenza- Invoice SP1635.pdf

2017Influenza - Invoice SP1506.pdf

2017DTaP- Invoice SP1515.pdf

2017BTS2 - Invoice SP1522.pdf

2017BTS - Invoice SP1521.pdf

2017AdolescentVaccine - Invoice SP1518.pdf

2017-18Influenza - Invoice SP1553.pdf

2016Meningitis - Invoice SP1457.pdf

2016Influenza - Invoice SP1497.pdf

2016Childhoold - Invoice SP1445.pdf

2016BTS - Invoice SP1472.pdf

2016-Adol- Invoice SP1442.pdf

REBrowns Flu Campaign.pdf

RE_ Flu Campaign Estimate and Media Brief.pdf

RE_ Browns ODH Bathroom Sign.pdf

RE_ Browns Flu Campaign.pdf

re Call with Sen Coley Cleveland Browns.pdf

RE Browns Flu Campaign ..pdf

ODH_Influenza - Estimate 176.pdf

FW_ Flu Campaign Estimate and Media Brief.pdf

ODH White Paper - Flu_Campaign (003).pdf

FY18 ODHInfluenza (Flu)-Media Brief.pdf

FW_ Additional Info on Browns Contract Waiver Request.pdf

Flu-Browns.pdf

Are taxpayers funding these efforts? Will the citizens of Ohio allow this to continue?  

Take Action!

→ Contact the Honorable Governor Mike DeWine's office (614) 644-4357, your State Representative, and your State Senator (Find your representatives here). Consider educating their offices on the following: 

1. The 1986 National Childhood Vaccine Injury Act shields vaccine manufacturers from liability for injury and death caused by their products.
2. The National Vaccine Injury Compensation Program has paid over $4.2 billion in compensation to date.
3. Vaccines are a for-profit pharmaceutical product. 
4. Inquire about the funding source(s) that paid for these invoices.

→ Inform others about the Vaccine Adverse Events Reporting System. Direct healthcare providers to the website, “VAERS Information for Healthcare Providers” [15] and the “VAERS Table of Reportable Events." [16]

→ Become familiar with the Ohio “State Checkbook” website and keep the state government accountable for its spending.

Resources:

[1] https://www.hrsa.gov/vaccine-compensation/covered-vaccines/index.html (accessed 10/19/19)

[2]  42 U.S.C. § 300aa-11 

[3] https://www.hrsa.gov/vaccine-compensation/about/index.html (accessed 10/19/19)

[4] https://www.hrsa.gov/vaccine-compensation/index.html (accessed 10/19/19)

[5] https://www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/data/data-statistics-october-2019.pdf (accessed 10/19/19)

[6]https://www.hrsa.gov/sites/default/files/vaccinecompensation/resources/84521booklet.pdf (accessed 10/19/19)

[7] https://www.hrsa.gov/vaccine-compensation/FAQ/index.html (accessed 10/19/19) 

[8] https://vaers.hhs.gov/ (accessed 10/19/19)

[9] https://vaers.hhs.gov/resources/infoproviders.html (accessed 10/19/19)

[10] https://healthit.ahrq.gov/ahrq-funded-projects/electronic-support-public-health-vaccine-adverse-event-reporting-system?fbclid=IwAR2oOjCjfXdmtUQ_jCKwujlAWOhtYNHhbyVOLRio-Yv9DOvvGMS3H3HzUm8 (accessed 10/19/19) 

[11] https://healthit.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf (accessed 10/19/19)

[12] https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/common-ingredients-us-licensed-vaccines (accessed 10/19/19)

[13]  https://www.cdc.gov/vaccines/acip/committee/index.html (accessed 10/19/19) 

[14]  https://www.nytimes.com/2009/12/18/health/policy/18cdc.html (accessed 10/19/19)

[15] https://vaers.hhs.gov/resources/infoproviders.html (accessed 10/18/19) 

[16]https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf (accessed 10/19/19)