(by Robert L. Kinney | LifeSite News) – Without a quiet change to federal law just before the onset of COVID-19, the experimental, mRNA COVID 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 COVID-19 mRNA vaccines. In December 2019 (before reported outbreak of COVID-19), 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 the 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.
Stated slightly differently, the U.S. federal government’s definition of “biological product” which was used up until a few weeks before the reported outbreak of COVID-19 may have prohibited the mRNA COVID-19 products from being labeled as vaccines.
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.
New definition of ‘biological product’ weeks before COVID
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. (emphasis added)
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 the mRNA COVID-19 vaccines chemically synthesize the SARS-CoV-2 “Spike” (also known as the “S”) protein. (As of the time of this writing in August 2021), both mRNA COVID-19 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 S protein.
Thus, the wording of the previous definition of “biological product” seems to suggest that the mRNA COVID-19 “vaccines” could not legally be labeled as vaccines. That would be a major problem for public health officials and “vaccine” makers.
COVID vaccines and ‘chemically synthesized’ mRNA
Without getting overly technical, it should be noted that COVID-19 mRNA vaccines are the first products which use the technique of “synthetic” or “chemically synthesized” mRNA to be given emergency use authorization by the FDA. (Pages 748-749) Read Full Article >