Integrative Biomedical Research

Integrative Biomedical Research (Journal of Angiotherapy) | Online ISSN  3068-6326
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REVIEWS   (Open Access)

Md Jabir Rashid1*, Md Sakil Amin1, Tufael2, Azizur Rahman3, Ahmed MH AlMudhafar 4 , Najah R Hadi 4

 

+ Author Affiliations

Integrative Biomedical Research 10 (2) 1-8 https://doi.org/10.25163/biomedical.10210949

Submitted: 04 August 2026 Revised: 25 September 2026  Accepted: 05 October 2026  Published: 07 October 2026 


Abstract

Seasonal influenza remains, year after year, a stubbornly persistent burden on global health systems, driving an estimated one billion infections and up to 650,000 respiratory deaths annually while straining economies through healthcare utilization and lost workplace productivity. Annual vaccination is still our best defense, yet the syringe-and-needle model that has dominated influenza immunization for decades carries costs of its own: needle phobia, occupational injury, a fragile cold chain, and a manufacturing pipeline that struggles to keep pace with a mutating virus. Microneedle (MN) array technology offers what may be the most credible alternative yet: patches, barely visible to the eye, that pierce only the outer skin layers, engage a dense network of Langerhans cells and dermal dendritic cells, and in doing so elicit immune responses that rival or exceed intramuscular injection at a fraction of the antigen dose. This review synthesizes evidence across immunological mechanisms, biomaterial engineering, clinical trial outcomes, and manufacturing science to characterize where the field currently stands and, more importantly, where the persistent "lab-to-clinic gap" remains unresolved. Dissolving microneedles emerge as the most clinically mature platform, offering dose-sparing, ambient thermostability, and needle-free self-administration validated across several Phase I/II trials. Yet no influenza microneedle patch has reached commercial licensure, a fact that reflects unresolved engineering, sterilization, and regulatory hurdles rather than scientific failure. We argue that closing this gap will require coordinated progress in current Good Manufacturing Practice scale-up, aseptic processing, and combination-product regulatory science, rather than further proof-of-concept studies alone.

Keywords: Microneedle vaccination; Seasonal influenza vaccine; Dissolving microneedle patches; Transdermal immunization; Skin-resident immune cells; Vaccine manufacturing scale-up; Lab-to-clinic translation

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