Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China

To, 2021, An overview of rational design of mRNA-based therapeutics and vaccines, Expet Opin Drug Discov, 16, 1307, 10.1080/17460441.2021.1935859 Linares-Fernández, 2020, Tailoring mRNA vaccine to balance innate/adaptive immune response, Trends Mol Med, 26, 311, 10.1016/j.molmed.2019.10.002 Kobiyama, 2022, Making innate sense of mRNA vaccine adjuvanticity, Nat Immunol, 23, 474, 10.1038/s41590-022-01168-4 Tenchov, 2021, Lipid Nanoparticles─From liposomes to mRNA vaccine delivery, a landscape of research diversity and advancement, ACS Nano, 15, 16982, 10.1021/acsnano.1c04996 Buschmann, 2021, Nanomaterial delivery systems for mRNA vaccines, Vaccines, 9, 65, 10.3390/vaccines9010065 Kedmi, 2010, The systemic toxicity of positively charged lipid nanoparticles and the role of Toll-like receptor 4 in immune activation, Biomaterials, 31, 6867, 10.1016/j.biomaterials.2010.05.027 Pizzuto, 2018, Cationic lipids as one-component vaccine adjuvants: a promising alternative to alum, J Contr Release, 287, 67, 10.1016/j.jconrel.2018.08.020 Hsieh, 2020, Structure-based design of prefusion-stabilized SARS-CoV-2spikes, Science, 369, 1501, 10.1126/science.abd0826 Crank, 2019, A proof of concept for structure-based vaccine design targeting RSV in humans, Science, 365, 505, 10.1126/science.aav9033 Asrani, 2018, Optimization of mRNA untranslated regions for improved expression of therapeutic mRNA, RNA Biol, 15, 756 Richner, 2017, Modified mRNA vaccines protect against zika virus infection [published correction appears in cell. 2017 mar 23;169(1):176], Cell, 168, 1114, 10.1016/j.cell.2017.02.017 Karikó, 2008, Incorporation of pseudouridine into mRNA yields superior nonimmunogenic vector with increased translational capacity and biological stability, Mol Ther, 16, 1833, 10.1038/mt.2008.200 Anderson, 2010, Incorporation of pseudouridine into mRNA enhances translation by diminishing PKR activation, Nucleic Acids Res, 38, 5884, 10.1093/nar/gkq347 Svitkin, 2017, N1-methyl-pseudouridine in mRNA enhances translation through eIF2α-dependent and independent mechanisms by increasing ribosome density, Nucleic Acids Res, 45, 6023, 10.1093/nar/gkx135 Mikkola, 2001, The effect of secondary structure on cleavage of the phosphodiester bonds of RNA, Cell Biochem Biophys, 34, 95, 10.1385/CBB:34:1:95 Habjan, 2013, Sequestration by IFIT1 impairs translation of2'O-unmethylated capped RNA, PLoS Pathog, 9, 10.1371/journal.ppat.1003663 Diamond, 2014, IFIT1: a dual sensor and effector molecule that detects non-2'-O methylated viral RNA and inhibits its translation [J], Cytokine Growth Factor Rev, 25, 543, 10.1016/j.cytogfr.2014.05.002 Passmore, 2022, Roles of mRNA poly(A) tails in regulation of eukaryotic gene expression, Nat Rev Mol Cell Biol, 23, 93, 10.1038/s41580-021-00417-y Mashino, 1983, Hemolytic activities of various phospholipids and their relation to the rate of transfer between membranes, J Biochem, 94, 821, 10.1093/oxfordjournals.jbchem.a134424 Hassett, 2021, Impact of lipid nanoparticle size on mRNA vaccine immunogenicity, J Contr Release, 335, 237, 10.1016/j.jconrel.2021.05.021 Alfonzo, 2021, A call for direct sequencing of full-length RNAs to identify all modifications, Nat Genet, 53, 1113, 10.1038/s41588-021-00903-1 Zhang, 2020, A thermostable mRNA vaccine against COVID-19, Cell, 182, 1271, 10.1016/j.cell.2020.07.024 Benteyn, 2015, mRNA-based dendritic cell vaccines, Expert Rev Vaccines, 14, 161, 10.1586/14760584.2014.957684 Sabnis, 2018, A novel amino lipid series for mRNA delivery: improved endosomal escape and sustained pharmacology and safety in non-human primates, Mol Ther, 26, 1509, 10.1016/j.ymthe.2018.03.010 Hassett, 2019, Optimization of lipid nanoparticles for intramuscular administration of mRNA vaccines, Mol Ther Nucleic Acids, 15, 1, 10.1016/j.omtn.2019.01.013 Collier, 2023, Immunogenicity of BA.5 bivalent mRNA vaccine boosters, N Engl J Med, 388, 565, 10.1056/NEJMc2213948