Project Bioshield Act of 2004 and PREP Act of 2005

Legal immunity for Pfizer, Moderna, hospitals, nursing homes, pharmacies, clinics, nurses, doctors, pharmacists.

Looking today at Project Bioshield Act of 2004, PL-108-276, and the Public Readiness and Emergency Preparedness (PREP) Act of 2005, PL-109-148, 42 U.S.C. 247d-6d et. seq. which together made a lot amendments to the Public Health Service Act of 1944, 42 USC 247(d), and paved the road we’re traveling on now.

NOTE TO READERS: I’m still sorting out the various, tangled dates of executive branch declarations and legislative/statutory citations, so there will be edits to this post, after it’s posted, to correct errors and make clarifications.

The Project Bioshield Act (30 pages) was passed by Congress and signed by President George W. Bush on July 21, 2004.

The PREP Act was passed by Congress and signed into law on Dec. 30, 2005. It was tagged on as the last 14 pages of a 154-page Department of Defense supplemental appropriations and Hurricane Katrina relief bill.

Together, these two laws changed a lot of federal laws related to bioterrorism, pandemics, drug development, appropriations, contracting, procurement, and product liability.

Project Bioshield was

“established to help incentivize private industry to develop vitally needed medical countermeasures by providing multi-year funding to support advanced research, clinical development, manufacture and procurement. Without this secure source of funding, companies do not have the incentive needed to develop the medical countermeasures that are critical to national security.

Together with several other laws, the Project Bioshield Act and PREP Act appear to be the source of the US Secretary of Health and Human Services’ Emergency Use Authorization (EUA) power, through which HHS Secretary Alex Azar first declared Covid-19 a public health emergency a public health emergency on Jan. 31, 2020 (the day after World Health Organization Director-General Tedros declared it a “public health emergency of international concern.”)

Azar then issued a “declaration for medical countermeasures” for Covid-19 on March 10, 2020, retroactive to February 4, 2020, followed by other declarations and amendments to the original declarations.

Azar’s PREP Act declaration bestowed immunity for liability on developers, manufacturers, distributors and vaccinators, for injuries and deaths caused by vaccines developed, manufactured, distributed and administered under Emergency Use Authorization.

The only exception is for “willful misconduct,” which might apply to Pfizer and Moderna if the clinical trial fraud alleged by whistleblower Brook Jackson can be proved — as Edward Dowd and others are working toward. But it would probably not apply to distributors and injectors who can credibly claim they had no knowledge of the clinical trial fraud.

HHS Secretary Azar’s declaration also rendered contractors like Pfizer, Moderna, nurses and pharmacists, as classifiable, in legal terms, as government employees of the Department of Health and Human Services for purposes of the Federal Tort Claims Act and related laws: 28 USC 1346(b) and 28 USC 2672.

The HHS PREP Act declaration has been amended several times since March 2020, each time expanding its reach, most recently on Jan. 7, 2022 (10th amendment).

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The Project Bioshield Act of 2004 includes provisions specifically addressing how EUAs are to be declared, maintained and terminated, at 21 USC 360bbb-3, relating to use of “unapproved products” or “unapproved uses of approved products.”

The effect of Azar’s PREP Act declaration, through the Project Bioshield Act of 2004, was to authorize government-funded development, marketing, distribution and deployment, by the contractors (Pfizer, Moderna, hospitals, nursing homes, clinics, pharmacies, nurses, pharmacists, etc.) of the pharmaceutical products marketed as “Covid-19 vaccines.”

Crucially, the EUA could only be initiated and maintained by denying that safe, effective medications such as hydroxychloroquine, Ivermectin, anti-inflammatory drugs, anti-coagulants, anti-virals and vitamins, existed for the treatment of the symptoms of Covid-19. This was the reason the US government and propaganda apparatus viciously attacked doctors and nurses who successfully treated patient symptoms with existing medications targeting those symptoms (inflammation, clotting, etc.) and then tried to share their successful treatments with other doctors, nurses and the general public.

That’s why the EUA provisions at 360bbb were challenged by a petition to federal court filed in Alabama on July 19, 2021, by America’s Frontline Doctors against Secretary of Health and Human Services Xavier Becerra, Fauci, Woodcock, HHS, FDA, CDC, NIH, NIAID, et al, 2:21-cv-00702-CLM. Which has been slowly working its way through the court system.

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Today at Coffee and Covid, Jeff Childers addressed the Moderna application for EUA approval for injections for babies and young children, asking the question:

“If emergency use authorization only applies during an emergency, how are the EUA vaccines still viable? It’s been over two years. Everybody agrees the pandemic is over, and we are learning to “live with Covid.” When do these EUA licenses expire?”

It’s not true that “everybody agrees the pandemic is over.”

The World Health Organization Director-General declaration of the “public health emergency of international concern,” originally issued Jan. 30, 2020, is still in full force.

The US Secretary of Health and Human Services PREP Act emergency declaration and related declarations, that began Jan. 31, 2020, are still in full force, temporary ‘rollbacks’ and ‘pauses’ and ‘updated guidance’ notwithstanding.

On Feb. 18, 2022, President Biden indefinitely extended the original national state of emergency declared by President Trump on March 13, 2020.

Under the circumstances, the EUA status still applies, and there’s no legal liability for any injuries or deaths caused by manufacturers and vaccinators.

21 USC 360bbb-3(b)(2) addresses “Termination” of an EUA:

(A) In general, A declaration under this subsection shall terminate upon the earlier of—

(i) a determination by the Secretary, in consultation as appropriate with the Sec- retary of Homeland Security or the Sec- retary of Defense, that the circumstances described in paragraph (1) have ceased to exist; or

(ii) a change in the approval status of the product such that the circumstances described in subsection (a)(2) have ceased to exist.

EUA seems to expire when the HHS Secretary says so, or when the EUA products get full approval, whichever comes first.

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The PREP Act has been interpreted by at least one court (Appellate Division of Supreme Court of New York) to even shield manufacturers and vaccinators from liability for injury and death when the treatment was given without consent, relating to H1N1 ‘vaccines.’ See Parker v. St. Lawrence, 102 A.D.3d 140 (2012):

Liability protections for pandemic countermeasures taken by certain "covered persons" in response to a declaration of a public health emergency by the Secretary are specifically provided for in the PREP Act (see 42 USC § 247d-6d [a], [b]). It provides that "a covered person shall be immune from suit and liability under Federal and State lawwith respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to ... an individual of a covered countermeasure" pursuant to a declaration of, among other things, a public health emergency (42 USC § 247d-6d [a] [1] [emphasis added]).

The statute broadly defines "loss" as "any type of loss, including... physical, mental, or emotional injury" or fear thereof (42 USC § 247d-6d [a] [2] [A] [ii]-[iii]), and provides that its immunity provision applies to "any claim for loss that has a causal relationship with the administration to ... an individual of a covered countermeasure," including, among other things, "dispensing [and] administration" (42 USC § 247d-6d [a] [2] [B] [emphasis added]). The "sole exception" to immunity from suit and liability is a federal action for "death or serious physical injury proximately caused by willful misconduct" (42 USC § 247d-6d [d] [1]).[4]

Considering the breadth of the preemption clause together with the sweeping language of the statute's immunity provision, 144*144 we conclude that Congress intended to preempt all state law tort claims arising from the administration of covered countermeasures by a qualified person pursuant to a declaration by the Secretary, including one based upon a defendant's failure to obtain consent (see Bruesewitz v Wyeth LLC, 562 US ___, ___, 131 S Ct 1068, 1088 [2011]). Notably, Congress created an alternative administrative remedy — the Countermeasures Injury Compensation Program — for covered injuries stemming from countermeasures taken in response to the declaration of a public health emergency (see 42 USC § 247d-6e [a]; 74 Fed Reg at 51154),[5] as well as a separate federal cause of action for wrongful death or serious physical injury caused by the willful misconduct of covered individuals or entities (see 42 USC § 247d-6d [d]). The provision of these exclusive federal remedies further supports our finding of preemption.

We are unpersuaded by plaintiff's assertion that immunity pursuant to the PREP Act does not extend to qualified persons who administer a covered countermeasure to an individual without consent. The immunity provisions of the PREP Act are triggered where, as here, the vaccines are purchased pursuant to a federal contract or agreement (see 75 Fed Reg 63656, 63658 [2010]) and, despite plaintiff's assertions to the contrary, Executive Order No. 29 neither defines nor otherwise places limitations upon the scope or applicability of such immunity.[6]

Plaintiff also asserts that Congress could not have intended to immunize such "radical measures" as administering a vaccination without consent. It is not our role, however, to speculate upon congressional judgments. Rather, we must presume that Congress fully understood that errors in administering a vaccination program may have physical as well as emotional consequences, and determined that such potential tort liability must give way to the need to promptly and efficiently respond to a pandemic or other public health emergency.

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Aggregated, the new laws, amendments to existing laws, HHS regulations and declarations put into place since the mid-2000s, and now cited by the US-HHS Assistant Secretary for Preparedness and Response as the source of authority for the Covid-19 project, are the laws that the United States government was forced to adopt and implement upon becoming a member party to the 2005 World Health Organization International Health Regulations.

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List of US government Covid-19 declarations: government rule by unilateral, unreviewable, unappealable proclamation made by unelected technocrats. Interestingly, the Feb. 4, 2020 medical countermeasures declaration doesn’t appear in the timeline created by Congressional Research Service through June 2021.

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