Breakthrough Needle-Free Vaccine Device Hits Milestone

Needle-Free Vaccine Breakthrough: PharmaJet’s Tropis® Device Achieves Primary Endpoints in Pivotal Clinical Trial

GOLDEN, Colo. – November 25, 2025 – PharmaJet Inc. today announced that its Tropis® Needle-Free Precision Delivery System has met all primary immunogenicity and safety endpoints in a 600-participant Phase II trial evaluating a next-generation COVID-19 DNA vaccine. The open-label study, conducted at the University of Cape Town Lung Institute, is the largest to date to assess plasmid DNA administered solely by a spring-powered, intradermal device and marks the final clinical milestone before late-stage development.

Investigators reported seroconversion rates of 97 % for neutralizing antibodies and a 3.4-fold rise in spike-specific CD8+ T cells four weeks after the second dose—performance comparable to approved mRNA shots but without the need for ultra-cold chain logistics. Importantly, no related serious adverse events were recorded, and 92 % of participants rated the needle-free experience as “pain-free” or “mildly uncomfortable,” underscoring the device’s potential to improve uptake among needle-hesitant populations.

“These data validate what we have observed in ten prior trials: Tropis turns the skin into a highly efficient immune sensor,” said Chris Cappello, President & CEO of PharmaJet. “By eliminating sharps waste and requiring 80 % less antigen than intramuscular injection, we can compress development timelines and dramatically cut cost per dose—critical advantages when responding to emerging pathogens.”

The global vaccine delivery devices market is projected to reach US $8.4 billion by 2030, with needle-free systems capturing 17 % share, according to a 2024 Grand View Research estimate. Intradermal delivery, supported by WHO guidance for dose-sparing, has gained additional traction after a 2024 Nigerian study showed Tropis increased polio IPV coverage by 12 percentage points in hard-to-reach communities, saving an estimated US $1.27 per fully immunized child.

PharmaJet’s platform is already manufactured at industrial scale; the company can produce two million devices per month at its Colorado FDA-registered facility and has secured fill-finish partnerships on three continents. Regulatory dossiers for both the device and the DNA vaccine candidate will be submitted to the South African Health Products Regulatory Authority in Q1 2026, with parallel rolling reviews initiated at the European Medicines Agency and India’s CDSCO.

About PharmaJet

PharmaJet (www.pharmajet.com) is a private biotech company dedicated to precision needle-free injection systems for vaccines, therapeutics and diagnostics. Its CE-marked and FDA-cleared Tropis® and Stratis® devices have enabled eight commercial products, including the world’s first plasmid DNA COVID-19 vaccine, and have been used in more than 150 clinical studies across 32 countries.