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

Continued advances in microarray patch (MAP) technology are starting to make needle-free delivery of a broad range of vaccines an achievable goal. The drivers and potential benefits of a MAP platform for pandemic response and routine vaccination are clear and include dose-sparing, cold-chain elimination, increased safety, and potential self-administration. MAP technology is regarded as a priority innovation to overcome vaccination barriers, ensure equitable access, and improve the effectiveness of vaccines. Vaxxas, a global leader in this technology, has built a strong evidence-base for the commercial application of their high-density (HD) MAP platform, and is rapidly advancing scale-up of the manufacturing process for HD-MAPs. A greater awareness and understanding of the implications of the technology amongst supply-chain participants, regulatory authorities, and global healthcare organizations and foundations is needed to accelerate adoption and, particularly, to prepare for MAP use in pandemics. Key challenges remain in the commercialization of MAP technology and its adoption, including market acceptance, scale-up of production, regulatory approval, and the availability of capital to build advanced manufacturing infrastructure ahead of late-stage clinical trials.

Usability, acceptability, and feasibility of a High-Density Microarray Patch (HD-MAP) applicator as a delivery method for vaccination in clinical settings.

BACKGROUND: High-density microarray patch (HD-MAP) vaccines may increase vaccine acceptance and use. We aimed to ascertain whether professional immunizers (PIs) and other healthcare workers (HCWs) in Australia, a High-Income Country (HIC), found the HD-MAP applicator usable and acceptable for vaccine delivery. METHODS: This feasibility study recruited PIs and HCWs to administer/receive simulated HD-MAP administration, including via self-administration. We assessed usability against essential and desirable criteria. Participants completed a survey, rating their agreement to statements about HD-MAP administration. A subset also participated in an interview or focus group. Survey data were analyzed using descriptive statistics, and interviews were transcribed and subject to thematic analysis. RESULTS: We recruited 61 participants: 23 PIs and 38 HCWs. Findings indicated high usability and acceptability of HD-MAP use across both groups by a healthcare professional or trained user and for self-administration with safety measures in place. Most administrations met essential criteria, but PIs, on average, applied the HD-MAP for slightly less time than the required 10-seconds, which the HCWs achieved. PIs perceived safety concerns about home administration but found layperson self-administration acceptable in an emergency, pandemic, and rural or remote settings. CONCLUSIONS: Participants found HD-MAP administration usable and acceptable. Usability and acceptability are likely to be improved through end-user education and training.

Professional immunizers and healthcare workers found high-density microarray patch devices highly usable and acceptable to administer vaccines.HD-MAPs may have advantages over intramuscular injections in clinical settings and in pandemics.Vaccination with HD-MAP may improve acceptance for those with needle-related anxiety.