Open Letter to the HHS Secretary, RFK Jr.

PREP Act emergency declaration must be terminated.

Breaking news update: (Fox News) Department of Health and Human Services Secretary Robert F. Kennedy Jr. has paused a multimillion-dollar contract from the Biden administration to create a new COVID-19 vaccine. On Friday Kennedy also issued a stop-work order for the covid vaccine trial which was about to begin.

News article here.

I don’t know if this is a good signal or not - this would depend on the future steps that HHS will take. At the moment, this move only puts a stop to spending additional millions of taxpayers’ money on new versions of covid vaccines. It does not affect the shots that are on the market, and in fact, benefits Pfizer and Moderna. Did they reach this deal with Trump at the recent White House dinner where Trump bromanced with Bourla and called him a great person and an excellent business man? Both companies have been struggling with plummeting sales and restructuring, so they are probably breathing a sigh of relief that a non-injectable product competitor has been taken out for now.

Main Post - Letter to Secretary Kennedy.

This post is my open letter to the HHS Secretary Kennedy asking him to use his authority and terminate the PREP Act declaration for covid emergency. I posted this letter on X and I also sent it directly to RFK Jr. Please join me in calling for Secretary Kennedy to terminate the contrived, false state of emergency.

Transcript of the video message:

Secretary Kennedy,

All mRNA injections marketed as covid vaccines today are Emergency Use Authorized (EUA) Military Countermeasures. The EUA pathway is used only when the United States Secretary of Health and Human Services declares an emergency and issues a PREP Act declaration.

Section 564 of the FD&C Act exempts medical countermeasures from the pharmaceutical regulatory compliance or from the informed consent requirements for the duration of the PREP Act declaration of emergency.

While the manufacturers may choose and FDA may ask to undertake some of the activities typically expected from an investigational clinical trial and manufacturing validation process, none of the typical pharmaceutical regulatory standards are applicable in an enforceable way. If there is no enforcement of the law, it’s as if the law does not exist.

Misrepresentations of safety, efficacy or contents of EUA products are allowed by federal law. Thus, claims provided by the federal health authorities or manufacturers cannot be considered reliable sources of information.

When these products are pushed onto unsuspecting consumers, claims about safety, efficacy or contents of these products are based solely on the HHS Secretary’s opinion, which requires no supporting scientific evidence. Today 3 mRNA shots are listed on the CDC Childhood Vaccination Schedule to be given to 9 months old infants.

Secretary Kennedy, are we supposed to think that it is now YOUR opinion that they are safe and effective for babies? I do not believe that, knowing what you know about mRNA injections, you can honestly believe this yourself.

Current PREP Act emergency declaration for covid was extended by the previous administration by Xavier Becerra to last until December 31, 2029! https://public-inspection.federalregister.gov/2024-29108.pdf

Real emergencies do not last decades simply based on the opinion of a single public health official. There is no real emergency for covid in the United Sates or worldwide as you are well aware.

Continued PREP Act declarations, therefore, defy the observed reality and common sense, and represents a misuse and abuse of the federal law which was intended for declaring short-term emergencies in severe situations such as war or acts of terrorism. This law also did not envision shipping of billions of doses of medical products legally allowed to be adulterated and misbranded. Yet, this is precisely what is transpiring under the current PREP Act declaration today.

By keeping the PREP Act declaration in place, the current administration continues to contrive a non-existing emergency. This contrivance serves only the interests of pharmaceutical companies and those institutions that still mandate the shots, shielding them from liability for deaths and injuries caused by the falsely promoted inherently unsafe products.

Clearly, this contrivance does not serve the interests of the public at all. The continued disregard of the victims of the covid shots under the thorough liability shield of the PREP Act abuses the federal law and destroys any remaining shreds of the public trust in the government health authorities.

These products pose severe risk of harm and death to the public due to the absence of any enforceable pharmaceutical regulations.

The FDA and manufacturers falsely claim that these products are fully approved for age 12 and older as prophylactic vaccines. However, once someone is injured by these vaccines and seeks compensation for their injuries, they are informed that the products are not legally vaccines but countermeasures and the only avenue available to them is the Countermeasures Injury Compensation Program.

To date this program has denied almost all claims and paid only a few thousand dollars to a handful of victims, making a mockery of them and the unbearable toll of their permanently destroyed health. During your Congressional confirmation hearings you said that a healthy person has a thousand dreams while a sick person has only one dream. Were you sincere about helping the covid vaccine victims?

Secretary Kennedy, I respectfully ask you to:

• Please use your authority to immediately terminate the PREP Act emergency declaration for covid pandemic, as there is no such emergency in reality.

• Please also investigate the misuse and abuse of the federal law utilized in the so-called "pandemic response" and countermeasures that resulted in the greatest human tragedy in recorded history and also destroyed public trust in the government health agencies.

As a reminder why I say “knowing what you know” in the video above, here is my interview with RFK Jr on his podcast in 2023:

Robert Kennedy Jr. Podcast: Militarized Healthcare

The letter below contains more detailed information with references to the US federal law (for those who are interested in taking this up with you state legislators):

Dear Secretary Kennedy,

Please use your authority to terminate the PREP Act emergency declaration for covid pandemic, as there is none in reality. Please investigate the misuse and abuse of the federal law utilized in the "pandemic response" (described below) that has resulted in the greatest human tragedy in the world in recorded history and completely destroyed public trust in the government health agencies.

All covid injections on the market today are EUA Countermeasures, due to current PREP Act emergency declaration for covid public health emergency extended by the previous administration to December 31, 2029!

https://public-inspection.federalregister.gov/2024-29108.pdf

EUA Countermeasures including covid vaccines and other EUA drugs and devices pose severe risk of harm to the public due to absence of any enforceable pharmaceutical regulations.

Pursuant to Section 564 of the FD&C Act, as amended by PAHPRA, 2013, and the Supremacy Clause of the United States Constitution (Article VI, Clause 2), medical countermeasures have been exempted from testing using Good Laboratory Practices, Good Clinical Practices, including informed consent.

Under federal law, FDA must formally approve any new investigational drug product prior to a manufacturer introducing it into interstate commerce.[1] This process requires manufacturer to open an Investigational New Drug application and obtain an exemption from the FDA for its use in regulated clinical research (trials). This regulated process is therefore referred to as an “investigational” regulatory pathway. It requires a manufacturer to conduct regulated clinical research (trials) under the IND, obtaining Institutional Review Board’s (IRB) approval for clinical trial protocols, independent safety monitoring oversight, and informed consent from clinical trial volunteers. In addition, manufacture of the drugs and biologics subject to the investigational status is regulated by the current Good Manufacturing practices (cGMP)[2]

EUA Medical Countermeasures are radically different, non-investigational drugs, biologics and devices deployed under FDA’s authorization power known as the “Emergency Use Authorization” (EUA) process[3].

The EUA pathway is used only when the United States Secretary of Health and Human Services declares an emergency[4].

By law, the EUA status is non-investigational[5]: while the manufacturers may choose and FDA may ask to undertake some of the activities typically expected from an investigational clinical trial and manufacturing validation process, none of the typical pharmaceutical regulatory standards are applicable in an enforceable way.

FDA has the discretion to issue an EUA if, in the sole opinion of the HHS secretary, the product “may be effective” in treating the relevant disease or condition[6]. No other criteria for approval apply in an enforceable way. There is no strict requirement to conduct clinical trials prior to authorization. In addition, due to the unenforceability of the pharmaceutical regulations and non-investigational status of the product, regulated human clinical trials are not legally possible, as none of the clinical trial human subject protections can be ensured.

FDA will approve EUA products on incomplete/non-existent information based on an opinion that “known and potential benefit of the product” may “outweigh[s] the known and potential risks”[7] and considers it unlikely that “comprehensive effectiveness data” will be available before an EUA grant. In contrast, for an investigational drug (under normal regulatory approval process) the FDA “shall” deny approval if the applicant “do[es] not show that such drug is safe.”[8]

Therefore, the EUA status of a medical countermeasure precludes collection of the regulated clinical trial data and thus precludes reliable, valid scientific knowledge of risks and benefits associated with the EUA Countermeasure while it remains non-investigational.

There is no strict requirement for an Investigational New Drug exemption (IND), nor institutional review board (IRB) approval of a clinical trial protocol and informed consent forms. Thus, the EUA process makes it impossible to obtain meaningful informed consent from the recipients of the product.

Congress mandated that FDA directly inform health care professionals and product recipients of any “significant known and potential benefits and risks.”[9] However, given that formal regulated clinical trials are neither required nor possible for a non-investigational EUA product, there is no effective way to collect and collate reliable and scientifically valid information on risks and benefits of an EUA, thus making the informed consent mandated by Congress meaningless.

Furthermore, there are no required standards for quality-control in manufacturing; no inspections of manufacturing procedures; no lot-release testing and no prohibition on wide variability among lots; no prohibition on adulteration; and no required compliance with Current Good Manufacturing Practices. EUA products, even though unregulated and non-standardized, “shall not be deemed adulterated or misbranded.”[10]

In summary, the process by which the EUA products enter interstate commerce and claims about their safety, efficacy or contents are based solely on the HHS Secretary’s opinion, which requires no supporting scientific evidence. Misrepresentations of safety, efficacy or contents of EUA products are allowed by federal law. Thus, claims provided by the federal health authorities or manufacturers cannot be considered reliable sources of information.

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[1] See, e.g., 21 U.S.C. § 355 (drugs); 42 U.S.C. § 262 (biologics).

[2] CFR Title 21, including sections in parts 1-99, 200-299, 300-499, 600-799, and 800-1299.

[3] Section 564 FD&C Act. Note that the EUA pathway should not be confused with the “Expanded Access Use” regulatory pathway which is often colloquially referred to as an “emergency use”. The expanded access is an investigational pathway and is regulated in the same manner as all normal drug approvals. (21 CFR 312.310-320)

[4] 21 U.S.C. § 360bbb-3(a)(1), (b).

[5] 21 USC 360bbb-3(k): If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].

[6] 21 U.S.C. § 360bbb-3(c)(2)(A)

[7] 21 U.S.C. § 360bbb3(c)(2)(B)

[8] 21 U.S.C. § 355(d)(2); See also 42 U.S.C. § 262(a)(2)(RB) (biologic approved only if it actually “is . . . safe”).

[9] 21 U.S.C. § 360bbb-3(e)(1)(A)(II)

[10] 21 USC 360bbb-3a(c).

Art for today: The Fates, oil on linen, 32x38 in.