Pfizer-BioNTech COVID-19 Vaccine Emergency Use Moderna COVID-19 Vaccine Emergency Use Janssen COVID-19 Vaccine

Authorization Review Memorandum. Authorization Review Memorandum. Janssen Biotech Inc.,

FDA Decision Memorandum. December 11, 2020. FDA Decision Memorandum. December 18, 2020. a Janssen Pharmaceutical Company of Johnson & Johnson
Available from Available from FDA Decision Memorandum. February 27, 2021.
https://www.fda.gov/media/144416/download. https://www.fda.gov/media/144673/download. Available from
https://www.fda.gov/media/146338/download.
Notes:
1. “Lipid” is not mentioned in J&J EUA. Both Pfizer and Moderna vaccines are formulated in lipid nanoparticles (LNPs).
2. Lipid nanoparticles (LNPs) are the most clinically advanced non-viral gene delivery system. Lipid nanoparticles safely and effectively deliver nucleic acids, overcoming a major barrier preventing
the development and use of genetic medicines. LNPs are composed of lipids. They are a novel pharmaceutical drug delivery system (and part of nanoparticle drug delivery), and a novel
pharmaceutical formulation. LNPs as a drug delivery vehicle were first approved in 2018 for the siRNA drug, Onpattro. LNPs became more widely known in late 2020, as some COVID-19 vaccines
that use RNA vaccine technology coat the fragile mRNA strands with PEGylated lipid nanoparticles as their delivery vehicle (including both the Moderna and the Pfizer–BioNTech COVID-19
vaccines.
LNP Resources:
(a) https://www.precisionnanosystems.com/workflows/formulations/lipid-nanoparticles
(b) https://en.wikipedia.org/wiki/Solid_lipid_nanoparticle.