There is no scientific definition of vaccine in US biological product law.

Katherine Watt

Dec 13

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Reader question:

Is there a formal definition of vaccine in law?

My reply:

There is no scientific definition of vaccine in statute or regulation.

That's why I urged Kirk Moore to ask DOJ to provide proof that what they supplied to his office was a vaccine.

Aug. 8, 2023 - USA v. Dr. Kirk Moore et al. (Katherine Watt)

DOJ can't provide that proof, because the proof doesn’t exist.

Congress added the term 'vaccine' to the biological products law in 1970 for the first time but did not define the term or direct the executive agencies to adopt or promulgate scientific definitions in regulations.

March 12, 2024 - Statutory and regulatory definitions for drugs, biological products, and biosimilars. (Katherine Watt)
Aug. 26, 2024 - Intentional elusivity of definitions for virus and vaccine. (Katherine Watt)

There is a financial definition of ‘vaccine’ and a definition based on the design intention, adopted by Congress in 1987.

1987/12/22 - Congress and President Reagan passed Omnibus Budget Reconciliation Act of 1987, PL 100-203, 101 Stat. 1330, including Sec. 9201, Manufacturers Excise Tax on Certain Vaccines, to establish an excise tax on vaccines ordered and purchased by US government and manufactured by private companies, to fund the Vaccine Injury Compensation Trust Fund established in 1986.
This act is the only act through which Congress has ever defined the term ‘vaccine,’ defining ‘vaccine’ as “any vaccine (A) which is listed in the table contained in [26 USC 4131(b)(1)], and (B) which is manufactured or produced in the United States or which entered into the United States for consumption, use or warehousing.”
Congress in 1987 defined vaccine in the form that now appears at 26 USC 4132a(2) — “any substance designed to be administered to a human being for the prevention of 1 or more diseases” — but has never defined the term “vaccine” in physical, chemical or pharmacological terms, and neither has the HHS-FDA.
See Dean v. HHS, No. 16–1245V, 2018 WL 3104388, at * 9 (Fed. Cl. Spec. Mstr. May 29, 2018), cited in 86 FR 6249, HHS Final Rule, National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, “(defining ‘‘vaccine’’ as ‘‘any substance designed to be administered to a human being for the prevention of 1 or more diseases’’) (quoting 26 U.S.C. 4132(a)(2)).”

The lack of scientific definition for vaccine was reinforced/corroborated in 2011 by the US Supreme Court in Bruesewitz v. Wyeth, when the majority opinion stated at p. 13:

“Design defects…do not merit a single mention in the [1986 National Childhood Vaccine Injury Act] or the FDA’s regulations. Indeed, the FDA has never even spelled out in regulations the criteria it uses to decide whether a vaccine is safe and effective for its intended use.”

July 11, 2024 - On "unavoidable, adverse side effects" as deceptive language used to conceal the intentionality of vaccine toxicity. (Katherine Watt)
June 27, 2024 - Intentional infliction of harm is not a legitimate government purpose; enabling it is not a permissible legislative object. (Katherine Watt)

Justice Scalia did not write, but it is also true, that FDA has never spelled out in regulations the criteria it uses to identify a product as a vaccine.

In other words, FDA has never spelled out in regulations the criteria it uses to determine if a product is or is not a vaccine.

This is because there are no available methods to do so, because vaccines are not stable, purified products.

They are mixtures that are constantly changing composition from initial production up through the point of injection and within the living organism into which they're injected.