FRANKFORT, Ky. (Dec. 1, 2020) – A bill pre-filed in the Kentucky House would prohibit the state from requiring the vaccination of any person, and would push back against any future federal vaccine mandates, including any COVID-19 vaccine mandate.

Republicans Savannah Maddox, Mark Hart, Joseph M. Fischer, Thomas Huff, and Richard White prefiled the bill (BR301)  The stated purposes of the bill is “relating to ensuring basic liberties regarding immunizations” and Section 2 of the act names it the “Ensuring Bodily Autonomy and Informed Consent Act.”

The legislation would amend KRS 214.036, which, in part, sets forth religious and medical exemptions from the state’s childhood vaccine mandates. In addition to containing these exemptions, KRS 214.036 includes a provision that allows the Kentucky Cabinet for Health and Family Services to, in the event of an epidemic, require via emergency regulation the immunizations of “all persons” within an “area of epidemic” against “the disease responsible for such epidemic.” Arguably, as this section now stands, it would permit the state to require the vaccination of both children and adults during a purported COVID-19 epidemic.

BR 301 would delete the provision of KRS 214.036 allowing the state to require immunization in connection with an epidemic and would add language specifically stating that nothing contained in KRS 214.036 and several other statutes “shall be construed to permit the Cabinet for Health and Family Services or any other agent or instrumentality of the Commonwealth of Kentucky to require the immunization of any person.”

Section 3 of BR301 protects the right to informed consent and states, in part, “Whereas ensuring bodily autonomy and informed consent, which are basic requirements for due process, liberty, and the constitutional and statutory rights of Kentucky citizens, is compelling and immediate, an emergency is declared to exist…” Representative Savannah Maddox, one of those who pre-filed BR 301, has reportedly indicated that protecting the right of Kentuckians to decide for themselves whether they receive any COVID-19 vaccine motivated the pre-filing of the bill.

Effect on Federal Policy

Passage of legislation that preserves the right to make vaccination decisions, such as BR 301, would push back against any future federal vaccine mandates and protect a critical medical right. As discussed below, there is a real possibility that vaccine mandates will be issued from the federal level, that vaccine mandates will expand to cover adults as well as children and that mandates will include a COVID-19 vaccine requirement. Furthermore, there is a multitude of reasons that the members of the public should resist vaccine mandates and defend the right to make their own vaccination decisions.

Federal mandates which apply to both children and adults may be issued.

For years, the debate about vaccine mandates in the U.S. has primarily played out at the state level and with regard to children.

Currently, in the U.S., vaccine mandates exist at the state level and apply only to children (with the exception of vaccines mandated for adults in some fields of employment). States have historically allowed all or some of the following types of exemptions from mandates: 1) religious; 2) medical; 3) philosophical. In recent years, there’s been a  trend toward states bolstering their childhood mandates by rolling back or eliminating exemptions.

In fact, this trend toward stripping parental vaccination rights took an alarming turn very recently, albeit at a city level, when, on November 17, 2020, the District of Columbia City passed a law permitting children 11 years old and older to consent to vaccines on their own without parental knowledge or consent, and also requiring insurance companies, vaccine providers and schools to conceal the fact that the child has been vaccinated from the parent. The chair of the health committee which passed the bill, Vincent C. Gray (D-Ward 7), was quoted in the Washington Post as saying “the hope of an imminent corona­virus vaccine gave the bill new urgency.”

Many predicted, long before COVID-19, that the vaccine mandate debate would broaden on two levels, with a layer of federal mandates being added and mandates expanding to cover adults as well as children.

The centralization of power with regard to mandates, to the federal level, has been a global trend. Italy and Germany are examples of countries that had already, prior to COVID-19, issued vaccine mandates at the federal level. Argentina did so as well, enacting a law in December of 2018 mandating its entire vaccine schedule upon both children and adults and many pointed to Argentina’s law as a bellwether for what was coming for other countries.

The notion that vaccinations should occur throughout one’s lifetimes, instead of just during childhood, has been heavily pushed by the U.S. government. For example, the goal of vaccinating the U.S. population throughout individuals’ entire lifetimes is set forth in the National Vaccine Plan and the National Adult Immunization Plan, which can be found on the website of the U.S. Department of Health and Human Services (HHS).

This push for lifetime vaccinations has come from the global level as well, with the U.S. as a collaborator. In 2012, the World Health Assembly endorsed the Global Vaccine Action Plan (GVAP), which includes an objective of “creating strategies for reaching individuals throughout their life course.” The U.S. National Institute of Allergy and Infectious Diseases (NIAID), which is part of HHS, was a collaborator in the development of GVAP, along with the World Health Organization and the Bill and Melinda Gates Foundation, among other organizations.

Anyone following current events is aware that questions and concerns around the issue of the vaccine mandates are coming to a head within the context of COVID-19.

There is a multitude of reasons that the public should retain the right to make its own vaccine decisions.

Informed consent advocates cite many reasons that the public should not relinquish the power to make vaccination decisions to the state. They have many concerns about vaccine safety and the context in which vaccines are developed, used and regulated. Those concerns are too numerous to cover in one article, but some of the primary ones are discussed below.

Concern 1 – The administration of vaccines occurs largely outside of normal liability rules.

In the U.S., the manufacturers of many vaccines have been afforded highly unusual liability protections. Under U.S. law, all claims of harm pertaining to vaccines recommended by the Centers for Disease Control and Prevention (CDC) for routine use in children must proceed under a special system called the National Vaccine Injury Compensation Program (NVICP). Under this system, the vaccine manufacturers are shielded from liability, and taxpayers, rather than vaccine manufacturers, fund any award of damages through the payment of an excise tax. The CDC recommends some of these childhood vaccines for use in adults, such as the influenza vaccine, and, for these vaccines, the manufacturers’ shield from liability also extends to adult use.

In the NVICP process, HHS is the defendant and taxpayer-funded Department of Justice attorneys defend against the claims, generally arguing that the reported injuries were not caused by vaccines, and for the denial of compensation.

Additionally, under the NVICP process, vaccine manufacturers are not subject to discovery. Discovery is the process that allows parties to seek relevant information and records from each other during litigation, often requiring corporate defendants to produce records such as e-mails and research data and to answer interrogatories and requests for admissions.

The removal of liability and lack of discovery is nearly unique to the vaccine industry and are a stark departure from the legal liability rules applicable to the manufacturers of most products.

To date, over $4 billion has been paid out under the NVICP for claims of harm caused by vaccines.

The federal government has also granted protection from liability to the manufacturers of future COVID-19 vaccines. However, claims of harm from COVID-19 vaccines will be processed through the Countermeasures Injury Compensation Program (CICP), rather than through the NVICP. Like with the NVICP, concerns exist with regard to the CICP process about whether claims will be fairly heard and compensated.

Concern 2 – The business of vaccines occurs outside of the free markets.

The administration of vaccines in the U.S. occurs wholly outside of the context of free markets, thereby allowing vaccine manufacturers to escape many of the normal economic risks and costs associated with producing and selling a product. This scenario also confers profits to the vaccine manufacturers which are much greater than would be earned in a free market.

The federal government acts as a major player in the purchase of vaccines. It buys approximately half of all vaccines administered to children pursuant to a program called the Vaccines for Children Program. It’s also a player in vaccine patents and collaborates with pharmaceutical companies to develop new vaccines.

In addition to purchasing vaccines, the state plays another role in drumming up business for the vaccine industry: it mandates the use of its product. This creates forced demand, bestowing upon the industry the benefit of extremely high product sales. This also spares the vaccine industry from marketing costs, which are essentially shifted to the taxpayers.

The factors discussed above make vaccines one of the fastest-growing sources of revenue for the pharmaceutical industry. For example, it’s been reported that a vaccine (Prevnar 13) has recently been the product that generated the most sales for Pfizer, rather than a drug. The vaccine market is expected to continue growing at a rapid pace, particularly in light of COVID-19. It’s been projected that the global vaccine market will reach 104.87 billion dollars by 2027.

The enormous profit margins associated with vaccines may, in part, explain why, as of September 27, 2020, there were reportedly more than 200 COVID-19 vaccine candidates in preclinical and clinical development, including 11 in phase 3 trials. There are also hundreds of vaccines for other infectious diseases currently under development.

Concern 3 – The childhood and adult CDC vaccine schedules are rapidly growing and, once mandates are in place, they will likely also be applied to new vaccines not yet developed or approved.

In 1983, the CDC recommended 24 doses of 7 childhood vaccines. This was prior to the aforementioned removal of liability that began, in part, under the National Childhood Vaccine Injury Act of 1986. The CDC now recommends approximately 70 doses of 16 vaccines by age 18. The CDC has both a childhood vaccine schedule and an adult schedule. A person receiving all of the doses on both schedules will receive a lifetime total of nearly 150-lifetime doses.

Childhood vaccine mandates have generally been based, at least in part, on the CDC’s childhood schedule. Although no COVID-19 vaccine is currently included on any CDC schedule, it is reasonable to assume that one is likely to be included in the future. However, regardless of whether a COVID-19 vaccine is added to any CDC vaccine schedule, it is clear that one is likely to be approved for use in the U.S. imminently and that additional vaccines will be also approved for use.

Multiple bureaucrats have indicated that a COVID vaccine may be mandated. For example, on August 21, 2020, Virginia’s Health Commissioner Dr. Norman Oliver stated that he plans to mandate a coronavirus vaccine for all Virginians once one is publicly available.

This is despite the fact that many have expressed a reluctance to receiving a COVID-19 vaccine. For example, according to the Pew Research Center, a poll conducted in September of 2020 found that only 51% of those U.S. adults surveyed indicated that they would “definitely or probably” get a COVID-19 vaccine, which was a considerable drop from the 72% of those surveyed in May of 2020 who indicated an intent to get a COVID-19 vaccine.

Many medical professionals have also expressed a reluctance to receive the vaccine as well. For example, researchers from the University of California Los Angeles’ Karin Fielding School of Public Health surveyed healthcare personnel working in the Los Angeles metropolitan area in September and October of 2020 to assess COVID-19 vaccine acceptance and found that approximately two thirds (66.5%) of them “intend to delay vaccination,” indicating that they do not intend to get a COVID-19 vaccine upon it becoming available.

It is clear that there will continue to be new vaccines approved for use in the U.S. Likely, this will include a COVID-19 vaccine. It would be wise for the public to consider that allowing mandates for vaccines already approved will likely open the door to mandates also being imposed for the new ones headed our way.

Concern 4 – Government agencies regulating vaccines have failed to require measures to ensure their safety.

There is a concern that the regulatory capture of the agencies responsible for regulating the vaccine industry is reducing the rigorousness of government vaccine safety requirements.

The CDC and FDA have allowed those with financial conflicts of interest to be highly involved in the regulatory process. For example, the CDC has an advisory committee on the use of vaccines and the CDC has permitted members of the committee with financial ties to the vaccine industry, and those with financial conflicts of interest, to participate the committee’s deliberations regarding vaccine use. Such members have also been permitted to advocate positions during the advisory committee process. Additionally, a “revolving door” exists between U.S. agencies responsible for regulating the vaccine industry and vaccine manufacturers. This has, at times, involved high-level personnel in key positions, such as Julie Gerberding, who was director of the CDC from 2002 to 2009. After leaving the CDC in 2009, she took a position as head of Merck’s vaccine division.

COVID-19 vaccines developed pursuant to Operation Warp Speed may have even greater risks than most vaccines.

Operation Warp Speed will allow for the accelerated development, testing and licensure of experimental COVID-19 vaccines. Researchers will be permitted to deviate from normal animal study procedures. This is despite the fact that some animal studies conducted in connection with vaccines under development for other coronaviruses (which were never licensed) have had concerning safety results. (Episode 177 of the HighWire, beginning at 25 minutes, contains a discussion of “immune enhancement,” a dangerous condition that’s been found during these animal studies.) Some of the COVID-19 vaccines being fast-tracked will use entirely new technologies (e.g., manufacturing methods using mRNA, DNA and nanoparticle genetic engineering technology; a delivery method using a microneedle array equipped with fluorescent quantum dot tags, rather than a conventional injection). Further, there are concerns that COVID-19 mRNA vaccines may alter human RNA and DNA.

Additionally, ICAN has uncovered concerning information indicating a governmental conflict of interest in connection with mRNA technology being used in a COVID-19 vaccine—that personnel from NIAID stand to profit from the potential sales of a Moderna vaccine under development which uses mRNA technology.

States must resist federal vaccine mandates and individuals must preserve the right to informed consent. 

As we have seen with marijuana and industrial hemp, federal regulation becomes ineffective when states enact contradictory policies. If multiple states ban mandatory vaccinations or pass laws which conflict with the CDC’s recommended schedules, it will become difficult for the federal government to enforce future federal mandates. Such state laws will also undermine the federal narrative and make it more difficult for the feds to generate support for nationwide mandatory vaccine policies.

WHAT’S NEXT

BR301 will be officially introduced when the Kentucky General Assembly convenes on Jan. 25. At that time it will receive a bill number and committee assignment. It will need to pass committee by a majority vote before moving forward in the legislative process.

Below are resources for those interested in more information about vaccines.


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