Opportunities and challenges for commercializing microarray patches for vaccination from a MAP developer’s perspective

References

• Prausnitz M. Engineering microneedle patches for vaccination and drug delivery to skin. Annu Rev Chem Biomol Eng. 2017;8:177–6. doi:10.1146/annurev-chembioeng-060816-101514.
   PubMed Web of Science ®Google Scholar
• Lawrence G. The hypodermic syringe. Lancet. 2002;359:1074. doi:10.1016/S0140-6736(02)08101-1.
   Google Scholar
• Portnoy A, Ozawa S, Grewal S, Norman BA, Rajgopal J, Gorham KM, Haidari LA, Brown ST, Lee BY. Costs of vaccine programs across 94 low- and middle-income countries. Vaccine. 2015;33(Suppl 1):A99–108. doi:10.1016/j.vaccine.2014.12.037.
   PubMedGoogle Scholar
• Bozorgi A, Fahimnia B. Transforming the vaccine supply chain in Australia: opportunities and challenges. Vaccine. 2021;39:6157–65. doi:10.1016/j.vaccine.2021.08.033.
   PubMed Web of Science ®Google Scholar
• Bozorgi A, Fahimnia B. Micro array patch (MAP) for the delivery of thermostable vaccines in Australia: a cost/benefit analysis. Vaccine. 2021;39:6166–73. doi:10.1016/j.vaccine.2021.08.016.
   PubMed Web of Science ®Google Scholar
• Lee BY, Bartsch SM, Mvundura M, Jarrahian C, Zapf KM, Marinan K, Wateska AR, Snyder B, Swaminathan S, Jacoby E, et al. An economic model assessing the value of microneedle patch delivery of the seasonal influenza vaccine. Vaccine. 2015;33:4727–36. doi:10.1016/j.vaccine.2015.02.076.
   PubMed Web of Science ®Google Scholar
• Galles NC, Liu PY, Updike RL, Fullman N, Nguyen J, Rolfe S, Sbarra AN, Schipp MF, Marks A, Abady GG . GBD 2020, release 1, vaccine coverage collaborators. measuring routine childhood vaccination coverage in 204 countries and territories, 1980-2019: a systematic analysis for the Global Burden of Disease Study 2020, release 1. Lancet. 2021;398:503–21. doi:10.1016/S0140-6736(21)00984-3.
   PubMed Web of Science ®Google Scholar
• Craig AT, Heywood AE, Worth H. Measles epidemic in Samoa and other Pacific islands. Lancet Infect Dis. 2020;20:273–75. doi:10.1016/S1473-3099(20)30053-0.
   PubMed Web of Science ®Google Scholar
• Forster AH, Witham K, Depelsenaire ACI, Veitch M, Wells JW, Wheatley A, Pryor M, Lickliter JD, Francis B, Rockman S, et al. Safety, tolerability, and immunogenicity of influenza vaccination with a high-density microarray patch: results from a randomized, controlled phase I clinical trial. PLoS Med. 2020;17:e1003024. doi:10.1371/journal.pmed.1003024.
   PubMed Web of Science ®Google Scholar
• Rouphael NG, Lai L, Tandon S, McCullough MP, Kong Y, Kabbani S, Natrajan MS, Xu Y, Zhu Y, Wang D, et al. Immunologic mechanisms of seasonal influenza vaccination administered by microneedle patch from a randomized phase I trial. NPJ Vaccines. 2021;6:89. doi:10.1038/s41541-021-00353-0.
   PubMed Web of Science ®Google Scholar
• Frew PM, Paine MB, Rouphael N, Schamel J, Chung Y, Mulligan MJ, Prausnitz MR. Acceptability of an inactivated influenza vaccine delivered by microneedle patch: results from a phase I clinical trial of safety, reactogenicity, and immunogenicity. Vaccine. 2020;38:7175–81. doi:10.1016/j.vaccine.2020.07.064.
   PubMed Web of Science ®Google Scholar
• The Vaccine Innovation Prioritisation Strategy. [Internet]. [accessed 2021 Dec 14]. https://www.gavi.org/our-alliance/market-shaping/vaccine-innovation-prioritisation-strategy
   Google Scholar
• Depelsenaire ACI, Meliga SC, McNeilly CL, Pearson FE, Coffey JW, Haigh OL, Flaim CJ, Frazer IH, Kendall MAF. Colocalization of cell death with antigen deposition in skin enhances vaccine immunogenicity. J Invest Dermatol. 2014;134:2361–70. doi:10.1038/jid.2014.174.
   PubMed Web of Science ®Google Scholar
• Muller DA, Fernando GJP, Owens NS, Agyei-Yeboah C, Wei JCJ, Depelsenaire ACI, Forster A, Fahey P, Weldon WC, Oberste MS, et al. High-Density microprojection array delivery to rat skin of low doses of trivalent inactivated poliovirus vaccine elicits potent neutralising antibody responses. Sci Rep. 2017;7:12644. doi:10.1038/s41598-017-13011-0.
   PubMed Web of Science ®Google Scholar
• Fernando GJP, Chen X, Prow TW, Crichton ML, Fairmaid EJ, Roberts MS, Frazer IH, Brown LE, Kendall MAF. Potent immunity to low doses of influenza vaccine by probabilistic guided micro-targeted skin delivery in a mouse model. PLoS ONE. 2010;5:e10266. doi:10.1371/journal.pone.0010266.
   PubMed Web of Science ®Google Scholar
• Rouphael NG, Paine M, Mosley R, Henry S, McAllister DV, Kalluri H, Pewin W, Frew PM, Yu T, Thornburg NJ, et al. The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial. Lancet. 2017;390:649–58. doi:10.1016/S0140-6736(17)30575-5.
   PubMed Web of Science ®Google Scholar
• Wan Y, Hickey JM, Bird C, Witham K, Fahey P, Forster A, Joshi SB, Volkin DB. Development of stabilizing formulations of a trivalent inactivated poliovirus vaccine in a dried state for delivery in the nanopatchTM microprojection array. J Pharm Sci. 2018;107:1540–51. doi:10.1016/j.xphs.2018.01.027.
   PubMed Web of Science ®Google Scholar
• Wan Y, Gupta V, Bird C, Pullagurla SR, Fahey P, Forster A, Volkin DB, Joshi SB. Formulation development and improved stability of a combination measles and rubella live-viral vaccine dried for use in the NanopatchTM microneedle delivery system. Hum Vaccines Immunother. 2021;17:2501–16.
   PubMed Web of Science ®Google Scholar
• Hirobe S, Azukizawa H, Hanafusa T, Matsuo K, Quan Y-S, Kamiyama F, Katayama I, Okada N, Nakagawa S. Clinical study and stability assessment of a novel transcutaneous influenza vaccination using a dissolving microneedle patch. Biomaterials. 2015;57:50–58. doi:10.1016/j.biomaterials.2015.04.007.
   PubMed Web of Science ®Google Scholar
• Iwata H, Kakita K, Imakuku K, Takashima S, Haga N, Yamaguchi Y, Taguchi K, Oyamada T. Safety and dose-sparing effect of japanese encephalitis vaccine administered by microneedle patch in uninfected, healthy adults (MNA-J): a randomised, partly blinded, active-controlled, phase I trial. Lancet Microbe. 2021. online. doi:10.1016/S2666-5247(21)00269-X.
   PubMedGoogle Scholar
• GPEI-The final frontier in polio eradication. [Internet]. [accessed 2021 Dec 14]. https://polioeradication.org/news-post/the-final-frontier-in-polio-eradication/
   Google Scholar
• Guillermet E, Alfa DA, Mai LTP, Subedi M, Demolis R, Giersing B, Jaillard P. End-User acceptability study of the nanopatchTM; a microarray patch (MAP) for child immunization in low and middle-income countries. Vaccine. 2019;37:4435–43. doi:10.1016/j.vaccine.2019.02.079.
   PubMed Web of Science ®Google Scholar
• Davies C, Taba M, Deng L, Karatas C, Bag S, Ross C, Forster A, Booy R, Skinner R. Usability, acceptability, and feasibility of a high-density microarray patch (HD-MAP) applicator as a delivery method for vaccination in clinical settings. Hum Vaccines Immunother. 2022; online. doi:10.1080/21645515.2021.2018863.
   Web of Science ®Google Scholar
• Hsieh C-L, Goldsmith JA, Schaub JM, DiVenere AM, Kuo H-C, Javanmardi K, Le KC, Wrapp D, Lee AG, Liu Y, et al. Structure-Based design of prefusion-stabilized SARS-CoV-2 spikes. Science. 2020;369:1501–05. doi:10.1126/science.abd0826.
   PubMed Web of Science ®Google Scholar
• McMillan CLD, Choo JJY, Idris A, Supramaniam A, Modhiran N, Amarilla AA, Isaacs A, Cheung STM, Liang B, Bielefeldt-Ohmann H, et al. Complete protection by a single-dose skin patch-delivered SARS-CoV-2 spike vaccine. Sci Adv. 2021;7:eabj8065. doi:10.1126/sciadv.abj8065.
   PubMed Web of Science ®Google Scholar
• Dolgin E. mRNA flu shots move into trials. Nat Rev Drug Discov. 2021;20:801–03. doi:10.1038/d41573-021-00176-7.
   PubMed Web of Science ®Google Scholar
• Maruggi G, Zhang C, Li J, Ulmer JB. Yu D. mRNA as a transformative technology for vaccine development to control infectious diseases. Mol Ther. 2019;27:757–72. doi:10.1016/j.ymthe.2019.01.020.
   PubMed Web of Science ®Google Scholar
• Developing pandemic-busting vaccines in 100 days [Internet]. CEPI; 2021 [accessed 2021 Dec 14]. https://100days.cepi.net/100-days/
   Google Scholar