By Alison Despathy

H.545 moved out of the House and now resides in Senate Health and Welfare for consideration. The committee is scheduled to vote on this bill at 10am Tuesday, February 10.  

H.545 has several key provisions. Specifically H.545: 

• Authorizes the Commissioner of Health to issue immunization recommendations for children and adults as part of the Department’s immunization program and purchase immunizations from either the Center for Disease Control or another vendor and requires health insurers to cover recommended immunizations 
• Provides immunity from civil and administrative liability for adverse events and death from immunizations for healthcare professionals acting in accordance with the standing orders and amends the membership of the Vermont Immunization Advisory Council

No one has any issue with the Commissioner’s continued ability to procure and purchase vaccines at a cost savings, including a requirement that health insurers fully cover recommended vaccines. This is already currently the law and slight expansions in this bill are not controversial. There are also no vaccine mandates included in this bill. 

The Commissioner’s ability to create a state based recommended schedule that could differ from the federally recommended schedule as well as offering a liability shield for health care professionals administering immunizations if injury or death occurs, without alerting patients or providing a standard for informed consent are the issues at hand. Constitutionality is of concern, meaning as currently written, if this bill becomes law, it will likely be litigated, as has been indicated.

The Federally recommended vaccine schedule recently shifted after comprehensive analysis by Health and Human Services (HHS). A comparison with the recommended schedules of 20 ‘peer countries’ Australia, Greece, Japan, France, UK etc, were reviewed to determine ‘consensus vaccines’, number of diseases and total injections given. 

The US was an outlier with the highest number of vaccines given to children and almost twice as many compared to some ‘peer countries.’ Currently the pharmaceutical industry and those administering vaccines cannot be held liable for any adverse events deaths from vaccines on the federally recommended schedule. This is a result of the 1986 National Childhood Vaccine Injury Act, which stemmed from the fact that many children were killed and injured from a Diphtheria, Pertussis, Tetanus (DPT) vaccine causing widespread neurological damage with lawsuits so rampant all but one vaccine manufacture went out of business.

Instead of directing the pharmaceutical industry to make safer products, a liability shield was granted and a special Vaccine Court and a National Vaccine Injury Compensation Program were created. Unfortunately and really criminally, this has become the cost of doing business for Big Pharma. If your child dies, like Nicole Matten of Barton, Vermont who lost her 7 year old daughter to myocarditis from a Fluzone vaccine containing mercury, you receive the highest payout of $250,000 dollars. Heartbreaking. 

$5,530,623,153.83 has been paid to those injured or killed by vaccines since 1988. 

This liability shield has resulted in compromised vaccine safety monitoring and there is both federal and state-level legislation to repeal and amend this law with hopes of making pharmaceutical companies responsible for the safety of their vaccine products. None of the vaccines on the federally recommended schedule have been tested with a double, blind, placebo control clinical trial and safety assessments have only been done for several days to months. Read that again.

Compare this to medications that Big Pharma is liable for which are tested against placebos with safety monitoring ranging from 2 – 8 years such as Lipitor, Lyrica, Enbrel, Eliquis etc. Why would Big Pharma pay to ensure a vaccine is safe, if they are not responsible for any harm done by their product? We should not expect anything else from convicted serial felons, responsible for profits to their shareholders. 

The recent Federal changes did not remove access to any vaccines and all are still covered by insurance with the liability shield in place. Instead, the updated schedule created three categories of vaccines: the recommended childhood immunization schedule, vaccines for those in high risk population or groups, and shared clinical decision making for several vaccines. This move aligns the US vaccine schedule with other ‘peer countries’, specifically Denmark. 

Now if you think of it, shouldn’t all vaccines fall into the shared clinical decision making category? Talk with your doctor, go through your history, behaviors, lifestyle choices, and a thorough benefit risk analysis of a vaccine, just like you would and should for all medication and medical procedures. 

H.545 would allow the state of VT to create their own recommended immunization schedule that could differ from the federal schedule and would offer healthcare providers a liability shield. Herein lies multiple problems in addition to creating widespread confusion, risk and legal recourse deficiencies. 

The best way to assess this issue is an example of Recombivax HB vaccine, the hepatitis B vaccine typically injected into babies on the first day of life. Hepatitis B vaccine is still available to all but has shifted to the category of high risk population, instead of routine injection for infants in the first 24 hours of life. 

Recombivax HB,was licensed in 1986 immediately after Big Pharma was offered a liability shield for any damages caused by vaccines. It was the first genetically modified virus used in a vaccine and it contains 250mcg of aluminum, a known neurotoxin, at a level 14 times greater than the allowable amount of aluminum in intravenous parenteral nutrition for an 8 pound baby.

• Prior to licensure, Recombivax HB was only studied for 5 days of safety monitoring with 147 children up to 10 years of age. 
• On October 12, 2017, Informed Consent Action Network (ICAN) sent a letter to HHS requesting the Hepatitis B safety data. 
• On January, 18, 2018, HHS and the Food and Drug Administration (FDA) sent a letter that failed to provide further clinical trial safety data. Two more letters were submitted to the FDA requesting safety data and were ignored. 
• Next a Freedom of Information Act (FOIA) demanding a copy of the clinical trials used to license Recombivax was submitted and a 1264 page document was finally shared by the FDA and confirmed that the vaccine was only reviewed for a few days of safety monitoring post injection. 
• On September 4, 2020, ICAN filed a petition to the FDA, “Demanding that the licensure of the Hepatitis B vaccine be revoked or suspended until their safety, as required by law, is determined in a properly designed clinical trial of sufficient duration.”

The Vermont Department of Heath has stated that they continue to recommend the hepatitis B vaccine for infants on the first day of life. Do you think parents know the history of Recombivax HB and that there are pending lawsuits based on insufficient safety monitoring? How might this affect their decisions? Is a healthcare provider ensuring informed consent with patients by offering a thorough benefit risk analysis? Did you receive informed consent when your child received a hepatitis B vaccine on the first day of life? 

If the state is going to create its own recommended schedule that differs from the federal schedule, what is this based upon? Who has access to the full clinical trials and research paid for my Big Pharma? These are not public records –although they should be– they are difficult to attain and typically require FOIA and lawsuits to the FDA and HHS to access. 

Does the state have resources and expertise to justify their deviation from the federally recommended immunization schedule? And if they do and providers have a liability shield from the state, if there is no longer federal preemption, does a patient have a right to know that the provider is not liable for death or damage from a vaccine? 

Should there be full transparency about the situation and a guaranteed and substantive requirement for informed consent? Should a patient have to attest to having received informed consent and understanding that the provider holds a liability shield. This is a basic consumer safety issue and in order to balance the scales of justice, there must be legal recourse, transparency and guaranteed informed consent provided to the patient,

The federal government had to do exactly this when the 1986 National Childhood Vaccine Injury Act passed Congress: a compensation program was created because a liability shield was offered to Big Pharma and vaccine administrators and there must be a path for legal recourse. A task force to study vaccine safety was also put in place and now 40 years later is finally and just recently activated to do the originally intended work of ensuring vaccine safety. Also a 10 page document was originally mandated to be used by doctors while communicating benefits and risks with patients in order to ensure informed consent.

Are you offered an honest benefit risk analysis when you receive a vaccine? Are you aware that Big Pharma and those administering vaccines cannot be held liable for federally recommended vaccines that maim or kill? Do you know that many flu vaccines still contain mercury, a potent neurotoxin? Do you know that the mercury from most vaccines was removed after it was determined that this neurotoxin was causing damage and then it was replaced with aluminum, another neurotoxin? Do you know that Measles, Mumps Rubella and Chicken Pox vaccines contain billions of human DNA and cells from aborted fetuses in each dose? Or that the National Vaccine Injury Compensation Program recognizes encephalopathy (brain inflammation) and Guillain-Barre syndrome as known side effects caused by some vaccines and approved for compensation. 

Would this information impact your decisions? Do you think that those giving vaccines should be required to convey this information, versus just saying these are ‘safe and effective’ or giving a Vaccine Information Statement which the CDC for decades has said does not constitute informed consent?

This is a glimpse into the issues at hand. What schedule will healthcare providers promote, which will schools use? Why is this necessary if all vaccines are still available, supposedly safe and effective and a patient can work with their provider to make their own private and personal healthcare decisions.

These are several of the currently unanswered questions related to H.545, which have raised constitutionality concerns as well as consumer protection issues for Vermonters. A lawsuit has been filed against a key supporter for H.545, the American Academy of Pediatrics. The lawsuit alleges “Racketeer Influenced and Corrupt Organizations Act (“RICO”), against the American Academy of Pediatrics for its central role in an enterprise that has defrauded American families about the safety of the childhood vaccine schedule for several decades.” 

The author is a clinical nutritionist in St. Johnsbury.