====== Lipid Nanoparticles in COVID-19 Vaccines ======

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The [[:mRNA]] [[:gene therapy]]-based [[:COVID-19 vaccines|COVID-19 vaccine products]] by [[:pharmaceutical_companies:Pfizer]] and [[:pharmaceutical_companies:Moderna]] both use artificial **lipid nanoparticles** (LNPs) to encapsulate and transport the enclosed mRNA payload through the cellular membrane of a patient's cells.((Schoenmaker, L., Witzigmann, D., Kulkarni, J. A., Verbeke, R., Kersten, G., Jiskoot, W., & Crommelin, D. (2021). //mRNA-lipid nanoparticle COVID-19 vaccines: structure and stability.// International Journal of Pharmaceutics, 601, 120586. https://doi.org/10.1016/j.ijpharm.2021.120586))

===== Physiological Effects =====

==== Inflammation ====

In addition to acting as a delivery system, the LNPs result "in transient local [[:inflammation]]" that is intended to stimulate the immune response by recruiting "neutrophils and antigen presenting cells" to the site of injection.((Schoenmaker, L., Witzigmann, D., Kulkarni, J. A., Verbeke, R., Kersten, G., Jiskoot, W., & Crommelin, D. (2021). //mRNA-lipid nanoparticle COVID-19 vaccines: structure and stability.// International Journal of Pharmaceutics, 601, 120586. https://doi.org/10.1016/j.ijpharm.2021.120586)) This theoretically nullifies the need to add additional adjuvants traditionally used in [[:vaccines]] such as [[:aluminum]], [[:mercury]] or [[: squalene]].((//Common Ingredients in U.S. Licensed Vaccines.// (2019, April 19). U.S. Food and Drug Administration (FDA). https://archive.ph/9ChiY))

===== Intellectual Property and Patents =====

The ownership and licensure of the LNP technology underlying the [[:mRNA]] [[:COVID-19 vaccines]] is controversial. See the below graphic from //Patent network analysis of mRNA-based vaccine candidates for COVID-19//:((Gaviria, M., & Kilic, B. (2021). //A network analysis of COVID-19 mRNA vaccine patents.// Nature Biotechnology, 39(5), 546–548. https://doi.org/10.1038/s41587-021-00912-9))

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==== Patents ====

The following patents are involved in the development of the LNP technology in question:

  * 2201121 - //Bilayer stabilizing components and their use in forming programmable fusogenic liposomes//((Madden, T. D., Cullis, P. R., & Holland, J. W. (1994). //Bilayer stabilizing components and their use in forming programmable fusogenic liposomes// (Canadian Intellectual Property Office Patent No. 2201121). https://www.ic.gc.ca/opic-cipo/cpd/eng/patent/2201121/summary.html?type=number_search&tabs1Index=tabs1_1))
==== Legal Challenges ====

On February 28, 2022, [[:pharmaceutical_companies:Arbutus Biopharma]] and [[:pharmaceutical_companies:Genevant Sciences]] filed a lawsuit against [[:pharmaceutical_companies:Moderna]], accusing the company of seven counts of patent infringement.((Choi, J. (2022, February 28). //Biotech firms allege Moderna hijacked technology to develop COVID-19 vaccine.// The Hill. https://archive.ph/vTcy9)) 

The suit alleges that Moderna had licensed Arbutus' LNP technology for its products, but not specifically for their [[:moderna_mrna-1273|mRNA-1273]] [[:COVID-19 vaccines|COVID-19 vaccine product]]. While the companies are seeking financial compensation, they insist they do not intend to halt or otherwise impede the distribution of the product. Moderna denied the allegations, claiming they had created their own proprietary lipid nanoparticle delivery technology for use in their [[:mRNA]] platform.