Lipid nanoparticle–based COVID-19 vaccines: Ensuring pharmaceutical stability, safety, and efficacy.

The article offers a review of U.S. Pharmacopeia (USP) chapters relating to the stability, efficacy and safety of messenger RNA (mRNA)-based lipid nanoparticle (LNP)-based COVID-19 vaccines. Topics discussed include the control of particulate matter in injections, particle size distribution (PSD) in lipid injectable emulsions, and technology for quantifying the critical large-diameter tail (LDT) region in PSD.