How big pharma multinationals, Gates and insiders coordinate politicians, scientists, health officials, media and public into VAX MANDATE DICTATORSHIP
Polypeptide synthesis is the biological production of peptides, which are organic compounds in which multiple amino acids are linked via peptide bonds. They are the building blocks of proteins which are essential to cell function. https://artofsmart.com.au/hsctogether/polypeptide-synthesis/
……………………….........................…12-12-18 Food and Drug Administration is proposing to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), and to provide its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.” Under that interpretation, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. A chemically synthesized polypeptide would mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. This proposed rule is intended to clarify the statutory framework under which such products are regulated. https://www.federalregister.gov/documents/2018/12/12/2018-26840/definition-of-the-term-biological-product
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FDA Finalizes New Definition of Biological Product
Jay J. Cho | Jordan
February 27, 2020
Last week the U.S. Food and Drug Administration issued a final rule to amend its regulation that defines the term “biological product” in line with the definition set by the Biologics Price Competition and Innovation Act of 2009, as amended by the Further Consolidated Appropriations Act, enacted on December 20, 2019 (“FCA Act”).
The BPCIA initially amended the definition of “biological product” in § 351(i) of the Public Health Service Act (“PHS Act”) to include a “protein,” but with a parenthetical carve-out excluding “any chemically synthesized polypeptide.” The FCA Act later struck this carve-out such that chemically synthesized polypeptides were no longer excluded from the statutory category of “protein.” The FDA’s final rule makes clear that the agency interprets the term “protein” in line with the latest statutory definition to mean “any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size,” regardless of whether it is chemically synthesized. https://www.biologicsblog.com/fda-finalizes-new-definition-of-biological-product
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November 03, 2021 by: Ethan Huff (Natural News)
In fact Congress paved the way for the introduction of these (vax) abominations as the “cure” for the Chinese Virus. Under the old rules a vaccine had to meet certain strict requirements in order to be considered an actual vaccine. What they are calling “covid vaccines” did not qualify.
Towards the end of 2019 however the federal government addressed this little problem by completely redefining the word vaccine to include novel biological products like mRNA (messenger RNA);
The Further Consolidated Appropriations Act, as the legislation is called, amended Section 351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1) to strike the words “except any chemically synthesized polypeptide” from SEC. 605. BIOLOGICAL PRODUCT DEFINITION.
“Thus, prior to the 2019 change which was made soon before the reported outbreak of COVID-19, ‘any chemically synthesized polypeptide’ would not be regulated by the FDA as a ‘biological product.’ This could be interpreted to mean that if a supposed vaccine was a ‘chemically synthesized polypeptide,’ then apparently it would not be regulated as a biological product,” reported LifeSiteNews.
“But chemicals labeled as vaccines require biologic product license applications; thus it seems that according to the previous definition of ‘biological product’ any chemical entity that is a chemically synthesized polypeptide could not be labeled as a vaccine.”
Since mRNA injections contain chemically synthesized spike protein (sequencing) they never would have qualified as vaccines under the rules,…had Congress not made these key legal changes in the final hours of Trump’s presidency, passing the baton off to Joe Biden, (pharma could not so easily have raced forward the vax….Possibly this link of big pharma-Congress is) why so many so-called Republicans in Congress are staying quiet and not speaking out against mandates and vaxxes,” one commenter at Natural News wrote.
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11-2-21 By Robert L. Kinney III
Without a quiet change to federal law just before the onset of COVID-19 the experimental mRNA jabs may never have been labelled as vaccines.
A previous article on LifeSiteNews.com described the major conflicts of interest
observable during the process leading up to the U.S federal government’s emergency use authorization of mRNA vaccines. In December 2019 the U.S. federal government signed a contract with one COVID-19 vaccine maker, Moderna, which “stated ‘mRNA coronavirus vaccine candidates [are] developed and jointly owned” by both Moderna and the U.S. federal government, the article explains.
This article discusses the additional significant fact that, also in December of 2019, the U.S. federal government changed the definition of “biological product” in federal laws governing vaccine labeling, emergency use authorization and approval. The U.S. federal government labels vaccines as “biological products.”
A thorough discussion of the significance of the change of the U.S. federal law cannot be provided here due to technical, scientific and pharmaceutical terminology and descriptions required. A basic summary is as follows: without the December 2019 change to U.S. law defining “biological product,” the mRNA COVID-19 vaccines may have been required to be labeled as something other than a vaccine….It would probably be much more difficult for governments and/or employers to mandate receiving coronavirus mRNA
substances labeled as drugs or other non-vaccine products. Guilt-tripping physicians, nurses and others into receiving and supporting mRNA COVID-19 substances with the potential false accusation of “anti-vaxxer” would also be out of the question if the substances were not labeled as vaccines.
It should be noted that to become approved in the United States vaccine manufacturers are required to submit a “Biologic License Application” to the U.S. federal government. (Page 2) U.S. federal law has vaccines included
in the category of “biological products.”
Prior to the 2019 change to U.S. federal law, the legal definition of biological product was as follows: The term “biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide) or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound) applicable to the prevention, treatment or cure of a disease or condition of human beings.
The December 2019 change to the definition of “biological product” is found in the Further Consolidated Appropriations Act, 2020, and is as follows: SEC. 605. BIOLOGICAL PRODUCT DEFINITION. Section 351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) is amended by striking “(except any chemically synthesized polypeptide).”
Thus, prior to the 2019 change which was made soon before the reported outbreak of COVID-19, “any chemically synthesized polypeptide” would not be regulated by the FDA as a “biological product.” This could be interpreted to mean that if a supposed “vaccine” was a “chemically synthesized polypeptide,” then apparently it would not be regulated as a biological product. But chemicals labeled as “vaccines” require biologic product license
applications; thus it seems that according to the previous definition of “biological product” any chemical entity that is a chemically synthesized polypeptide could not be labeled as a vaccine.
The significance of this change is that mRNA
vaccines chemically synthesize the SARS-CoV-2 spike protein. (As of the time of this writing in August 2021) both mRNA vaccines which were given “emergency use authorization” by the FDA are “nucleoside modified” which means that they are “chemically modified” and programmed to synthesize the SARS-CoV-2 spike protein. Thus the wording of the previous definition of “biological product” seems to suggest that mRNA “vaccines” could not legally be labeled as vaccines. That would be a major problem for public health officials and “vaccine” makers.
Without getting overly technical it should be noted that mRNA vaccines are the first products which use the technique of “synthetic” or “chemically synthesized” mRNA to be given emergency use authorization by FDA.
After injected into humans, the chemically synthesized mRNA vaccines (instruct cells to produce) a protein which is similar to the spike protein of SARS-2. Proteins “contain one or more polypeptides.” Thus the synthesis of the spike protein is also described as “polypeptide synthesis.”
A more specific explanation of the chemical synthesis of mRNA vaccines from the scientific literature is as follows:
The chemical components of mRNA vaccines are pleasantly unremarkable, consisting primarily of RNA plus “water, salt, sugar and fat,” with 2 notable exceptions. The first is the lipid nanoparticles that encapsulate the mRNA and facilitate its delivery, which are excellently reviewed elsewhere. The second is the non-natural RNA nucleobase N1-methylpseudouridine (m1Ψ, which enhances immune evasion and protein production. For this article it is important to know that a chemical component of mRNA vaccines is N1-methylpseudouridine. The chemical N1-methylpseudouridine “enhances…protein production. Protein production” may also be stated as “protein synthesis” or “polypeptide synthesis.” Another way to state this is that N1-methylpseudouridine is a chemical which participates in the polypeptide synthesis of the spike protein necessary for mRNA vaccines.
This means then that the spike protein necessary for mRNA vaccines could be accurately described as a “chemically synthesized polypeptide.” Now, refer to the definition of “biological product” before the December 2019 change to U.S. federal law. The law previously excluded “any chemically synthesized polypeptide” from the definition of “biological product.” That definition then would seemingly exclude mRNA vaccines from being labeled as a “biological product.”
But since vaccines require a Biologic License
Application, then it would seem that with the previous definition of “biological product,” mRNA “vaccines” could not be labeled as vaccines.
It is unknown if the legal definition of “biological product” was amended by Congress to remove “except any chemically synthesized polypeptide” to permit foreseen chemically synthesized mRNA substances to be labeled as “vaccines.”
However, the fact that this significant change was made on page 595 of a 716-page law (is peculiar). Specifically, the timing of the change - December of 2019 – along with the apparent hurried status – burying the change on page 595 of a U.S. federal funding act – again suggests the possibility that COVID-19 may be a pandemic which U.S. federal government public health officials and politicians were preparing for by attempting to legally protect themselves with several significant changes to laws, strategies and plans governing and regulating public health “emerging threats,” pandemics, vaccines or related subjects. …
Of course the timing and apparent conspicuousness of the 2019 change to the U.S. federal law which seemingly ensured that mRNA vaccines could legally be labeled as “vaccines” could merely be a coincidence. If keeping track of the large number of major coincidences regarding the pandemic, though, the reasonable person might at least be cautious of anything certain persons and entities communicate regarding this pandemic.
https://yournews.com/2021/11/02/2247752/congress-made-crucial-change-to-vaccine-definition-weeks-before-covid-19/
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