OBJECTIVES: Influenza disease turns out to be an important cause of morbidity and mortality. New alternatives to conventional needle-and-syringe vaccination look out for expanding the access and dissemination of influenza immunization. In this study, we described the current evidence regarding efficacy, safety and cost-effectiveness of a novel approach for influenza vaccination.

METHODS: Our Early-Awareness and Alert-System SINTESIS identified the use of a novel approach for influenza vaccination: “transcutaneous self-dissolving microneedle patches” in July 2017. An early assessment of the technology was conducted through systematic review on databases: PubMed, EMBASE, Web of Science, Tripdatabase, the International Clinical Trials Registry Platform, ClinicalTrials.gov, Cochrane Library and the Centre for Reviews and Dissemination. Search terms were as follows: microneedle patch [Title] AND influenza [Title].

RESULTS: We found 23 studies (11 basic research, 2 opinion pieces, 2 phase I clinical trials, 2 ongoing clinical trials without results, 2 economic studies and 4 studies that did not assessed this new technology). We found only 2 independent phase I clinical trials that evaluated transcutaneous self-dissolving microneedle patches developed by different research groups versus conventional immunization. No differences on treatment-related adverse events were found. In general, microneedle patches were well tolerated, although erythema was commonly reported after patch application. Antibody titers and seroconversion percentages were similar between intervention groups. Economic studies found the technology to be cost-effective, particularly in the event of an increased vaccination compliance.

CONCLUSIONS: Current evidence showed no differences in the immunization capacity of transcutaneous self-dissolving microneedle patches in relation to the needle-and-syringe vaccine. Economic studies seem to consider the technology to be cost-effective, however, estimates have been based on theoretical models. Further studies are needed to confirm these results. Early assessment of new and emerging technologies allowed for collection of minimum necessary information to support decision-making regarding their inclusion in the health system.