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

Abstract

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.

Immunogenicity, safety, usability and acceptability of microarray patches for vaccination: a systematic review and meta-analysis

“…Manufacturing costs are expected to be more expensive than for N&S,19 47 while some studies suggest MAPs may be more cost-effective for specific childhood immunisation programmes or if uptake was high enough 20 59 60. This is mainly due to MAP’s potential to reduce logistics and distribution cost due to improved thermostability, ease of use, improved safety, reduced wastage and higher acceptability 2 18 20 61. Offering an influenza MAP to children who refused N&S resulted in an increased cost but reduced infection rates and hospitalisations 19.…”

Microneedles: An Emerging Vaccine Delivery Tool and a Prospective Solution to the Challenges of SARS-CoV-2 Mass Vaccination

“…The U.S. government provided USD 430,000 to four groups for developing MNP through the Biomedical Advanced Research and Development Authority (BARDA) on 18 August 2020 [ 131 ]. Vaxxas is actively developing MN vaccines and is actively facing challenges with some partners, including BMGF, Merck and BARDA [ 132 ]. Vaxxas is advancing an easy-to-use device for the MN delivery of IPV vaccines, designed to deliver vaccines into the skin.…”

The Race to Manufacture COVID-19 Vaccines: Emerging Vaccine Technologies

“…Vaxxas is an Australian biotechnology company focused on enhancing the performance of vaccines and increasing access to vaccination using needle-free high-density microarray patch (HD-MAP) technology (Forster and Junger 2022). Vaxxas states that its patch technology is a "platform technology" that can potentially deliver any vaccine to the human body.…”