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Lipid Nanoparticles in COVID-19 Vaccines

The mRNA gene therapy-based COVID-19 vaccine products by Pfizer and Moderna both use artificial lipid nanoparticles (LNPs) to encapsulate and transport the enclosed mRNA payload through the cellular membrane of a patient's cells.1)

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.2) This theoretically nullifies the need to add additional adjuvants traditionally used in vaccines such as aluminum, mercury or squalene.3)

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-19:4)

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 liposomes5)

On February 28, 2022, Arbutus Biopharma and Genevant Sciences filed a lawsuit against Moderna, accusing the company of seven counts of patent infringement.6)

The suit alleges that Moderna had licensed Arbutus' LNP technology for its products, but not specifically for their mRNA-1273 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.

1) , 2)
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
3)
Common Ingredients in U.S. Licensed Vaccines. (2019, April 19). U.S. Food and Drug Administration (FDA). https://archive.ph/9ChiY
4)
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
5)
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
6)
Choi, J. (2022, February 28). Biotech firms allege Moderna hijacked technology to develop COVID-19 vaccine. The Hill. https://archive.ph/vTcy9
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