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A microneedle vaccine printer for thermostable COVID-19 mRNA vaccines.

Aurélien Vander StraetenMorteza SarmadiJohn L DaristotleMaria KanelliLisa H TostanoskiJoe CollinsApurva PardeshiJooli HanDhruv VarshneyBehnaz EshaghiJohnny GarciaTimothy A ForsterGary LiNandita MenonSydney L PyonLinzixuan ZhangCatherine Jacob-DolanOlivia C PowersKevin HallShahad K AlsaiariMorris WolfMark W TibbittRobert FarraDan H BarouchRobert S LangerAna Jaklenec
Published in: Nature biotechnology (2023)
Decentralized manufacture of thermostable mRNA vaccines in a microneedle patch (MNP) format could enhance vaccine access in low-resource communities by eliminating the need for a cold chain and trained healthcare personnel. Here we describe an automated process for printing MNP Coronavirus Disease 2019 (COVID-19) mRNA vaccines in a standalone device. The vaccine ink is composed of lipid nanoparticles loaded with mRNA and a dissolvable polymer blend that was optimized for high bioactivity by screening formulations in vitro. We demonstrate that the resulting MNPs are shelf stable for at least 6 months at room temperature when assessed using a model mRNA construct. Vaccine loading efficiency and microneedle dissolution suggest that efficacious, microgram-scale doses of mRNA encapsulated in lipid nanoparticles could be delivered with a single patch. Immunizations in mice using manually produced MNPs with mRNA encoding severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein receptor-binding domain stimulate long-term immune responses similar to those of intramuscular administration.
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