Microneedle Patches for PediatricVaccination: Technology, ImmunogenicAdvantages, Clinical Evidence, and FutureImplementation

Abstract

Microneedle patches (MNPs) represent a disruptive new modality for pediatric vaccination that overcomes some of the most enduring barriers to needle-based immunization, such as pain, fear of needles, logistical challenges, and dependence on cold-chain transportation. Though current subcutaneous and intramuscular injections are effective,
global disparities in vaccine coverage-apparently exacerbated by vaccine hesitancy, infrastructural impediments, and attrition associated with multiple-dose regimens-point to a need for new delivery platforms. MNPs enable antigen deposition in the immunologically rich epidermal and dermal layers, affording superior immunogenicity, dose sparing, and improved thermostability compared to conventional vaccine formulations. This review summarizes current evidence on microneedle design, pediatric-appropriate formulation considerations, and theimmunological advantages of skin-targeted delivery. Early clinical data, including measles–rubella trials in infants,demonstrate favorable safety profiles and robust seroconversion rates comparable to injections, while preclinical
studies highlight compatibility with multivalent and fractional-dose strategies. Manufacturing challenges, regulatory considerations, and ethical implications are discussed with an emphasis on pediatric-specific needs.Collectively, available data support MNPs as a promising modality for expanding global childhood immunization,particularly in low- and middle-income settings. Further large-scale pediatric trials and cost-effective industrialscale-up remain essential to accelerate their integration into routine immunization programs.