Medical Device Network

PharmaJet’s needle-free delivery system proves effective in published study

More than 3000 participants took part in the trial which showed that GEMCOVAC-OM administered with PharmaJet's Tropis boosts immune response.

A study, published in the Nature Journal, demonstrates that PharmaJet’s needle-free delivery system Tropis significantly boosts immune responses against the Omicron variant when used with Gennova Pharmaceuticals’ Covid-19 booster vaccine GEMCOVAC-OM.

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

Needle-free Injections are devices that do not use a needle to administer medication. They propel a small jet of liquid or powder at high speed through a microscopic orifice causing it to penetrate the skin for subcutaneous, intra-dermal, or intramuscular administration. Tropis uses the skin cells, like dendritic cells and macrophages, to trigger a stronger and wider immune response compared to injecting vaccines into the muscles.

Phase II of the trial involved 140 participants and compared the safety and immunogenicity of GEMCOVAC-OM with a prototype mRNA vaccine GEMCOVAC-19. Results showed a significant increase in anti-spike IgG antibodies with both vaccines at day 29 post-vaccination, with GEMCOVAC-OM demonstrating higher IgG titres compared to the prototype.

More than 3000 participants were involved in the safety cohort of the Phase III trial, with an additional 420 in the immunogenicity cohort. GEMCOVAC-OM showed superiority compared to ChAdOx1 Cov-19, confirming its effectiveness as a booster against the B.1.1.529 Omicron variant.

A report on GlobalData’s Medical Intelligence Center highlighted PharmaJet as a key player involved in the active development of needle-free injections, alongside include Crossject, Inovio Pharmaceuticals, and Boston Scientific to name a few.

The mRNA vaccine was licensed under emergency use authorisation in India in June 2023, following a rise in the incidence of Covid-19 in the country. As well as being needle-free, GEMCOVAC-OM is a thermostable vaccine that does not need ultra-cold chain infrastructure for its storage and transport, unlike other approved mRNA-based vaccines.

In the announcement accompanying the results, PharmaJet’s CEO Chris Cappello said: “This new data adds to the evidence base indicating Tropis needle-free ID administration is an enabler for vaccine platforms.”