The term “plasmid” is proposed – a precursor to biotechnology

Published October 1, 1952 Joshua Lederberg proposed the generic term "plasmid" for any simple or complex "extrachromosomal hereditary determinant". The term “plasmid” is derived as a hybrid of "cytoplasm" and "id" (Latin for 'it'). Plasmids were discovered in the 1940s but were referenced by a "plethora of terms" such as cytogenes, proviruses, pangenes etc. [1] A plasmid is circular DNA, found especially in bacteria, that is physically separate from the bacteria's chromosomal DNA, and can replicate separately. In 1958 Japanese scientists discovered the transferable R-factors in bacteria with plasmids which caused them to become antibiotic resistant. The year before, in 1951 Joshua’s wife, Esther Lederberg, discovered the bacteriophage (bacterial virus) lambda in E. coli. [4] Plasmids were the first instruments in genetic engineering.  Once Boyer & Cohen's 1972 collaborative finding that plasmid could be cut with a "restriction enzyme" and a foreign gene could be inserted, the stage was set for genetic revolution. [2] Pfizer-BioNTech used plasmids in antibiotic resistant E.coli to mass produce the SARS-CoV-2 spike mRNA for their COVID-19 vaccines (Process 2), which concerningly was a different process to the stock used in their clinical trials (Process 1). [3]

1st International mRNA Health Conference

On October 23-24, 2013 the 1st International mRNA Health Conference was held in Tübingen, Germany and herald a "New Era in Modern Medicine",  The event brought together more than 150 attendees from leading international pharmaceutical and biotechnology companies and academic institutions. This conference "laid the foundation for the new biotechnological sector of mRNA-based therapeutics." [1] Initiated by CureVac and the University of Tubingen in 2013, and held in the city of Tübingen "where nucleic acids were discovered over 140 years ago", the confernce became an annual event "for everyone who is working with mRNA for medical purposes or seeking messenger RNA as a novel tool to express proteins directly in situ." [2] A whole session was dedicated to mRNA vaccines of which Peter Brossart from the University of Bonn gave a presentation titled "Development of RNA based vaccines" [3] In Cambridge, Massachusetts on November 11-12, 2014 the second conference was held with gold sponsors being AstraZeneca, BioNTech, CureVac and Moderna. [3]  Moderna Therapeutics' presenation was titled "Is mRNA like software?". In 2014 Lipid Nanoparticle developer Acuitus presented this poster, and DARPA presented the "Impact of mRNA on Global Health"

FDA petition to amend mRNA label: including inaccurate notion of “efficacy against infection and tranmission”

On January 31, 2023 the Coalition Advocating for Adequately Labeled Medicines (CAALM) petitioned the FDA to "amend current product labeling" for Pfizer-BioNTech's and Moderna's COVID-19 mRNA vaccines.  The petition was heavily cited. Stating "[i]ncomplete, inaccurate, or misleading labeling of any medical product can negatively impact the health and safety of Americans, with global ramifications considering the international importance of FDA decisions." They noted "[t]here is a widespread (but inaccurate) notion that efficacy against infection and transmission have been established by substantial evidence, and that these vaccines contribute to herd immunity." Statements that have been inacurately repeated by "authorities". On April 18, 2023 the FDA resonded in a letter [1] with the alarming statement: “FDA authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission…Similarly, a vaccine can meet the EUA standard without any evidence that the vaccine prevents infection or transmission.” [pg 11] [So what is the purpose of a vaccine? If a vaccine doesn't prevent infection or stop transmission how does it contribute to herd immunity? Define "protection"!  Isn't reducing symptoms (it this is protection) put the product in the category of a drug?  Then the product would undergo a more stringent..> READ MORE