Intradermal Needle-Free samRNA Vaccine Delivery Found Safe

PharmaJet® today announced that the journal Nature published results from Gennova Biopharmaceutical's Phase 2/3 clinical trial. The trial was conducted to evaluate the safety and immunogenicity of its novel samRNA-based Covid-19 vaccine booster.

The study's results demonstrated that GEMCOVAC-OM, administered exclusively with Tropis®, is well-tolerated with no related serious adverse events and significantly boosts immune responses against the Omicron variant.

GEMCOVAC®-OM samRNA vaccine low dose was licensed under emergency use authorization in 2023.

This new study is the first time a samRNA vaccine has been developed with a lipid nano-emulsion, and the data show that intradermal administration of this vaccine is safe and well-tolerated.

Furthermore, the April 18, 2024 publication cited that the self-amplifying, thermostable mRNA platform delivered intradermally with Tropis provides a framework for next-generation vaccines that can improve accessibility and global equity.

PharmaJet has partnered with Gennova to improve the performance and outcomes of their samRNA platform with PharmaJet's breakthrough delivery technology. 

The PharmaJet pioneering technology unlocks the rich potential of the human dermis, paving the way for enhanced immune responses.

Chris Cappello, President and Chief Executive Officer, PharmaJet, commented in a press release on April 24, 2024, "This new data adds to the evidence base indicating Tropis needle-free ID administration is an enabler for vaccine platforms."

Tropis intradermal administration and Stratis® SC/IM (for intramuscular and subcutaneous administration) are the only commercially scaled needle-free technologies that enhance the performance of several vaccines and therapeutics.

Since its launch, Tropis has performed over 10 million vaccinations in several countries.