Vaxxas’ needle-free seasonal influenza vaccine enters clinical trial

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Vaxxas, a biotechnology company commercialising a novel vaccination platform, has commenced the Phase I clinical trial of the first needle-free inactivated seasonal influenza vaccine quadrivalent (IIV4) candidate via its proprietary high-density microarray patch (HD-MAP) technology. 

The clinical trial will examine the safety, tolerability, and immunogenicity of the inactivated influenza IIV4 candidate in approximately 150 healthy participants, ages 18 to 50 years. 

In a media release, the company explained how IIV4 influenza vaccines target four significant strains of influenza virus, offering broad immune coverage against the flu viruses expected to circulate across the globe for a given flu season. 

The specific strains of influenza virus targeted in any given season IIV4 are established annually by regulatory health agencies and encompass two strains of influenza A and two strains of influenza B. 

David Hoey, CEO of Vaxxas, said vaccines delivered via an HD-MAP patch is designed for ease of use and can potentially be self-administered. The technology also simplifies distribution by removing or reducing the need for refrigeration and avoids the need for needles. 

“All factors that could improve access to, and acceptability of, current influenza vaccines, offering greater protection each season to communities around the globe,” Hoey said. 

Researchers found that fear of needles affects up to 25 per cent of adults, which could result in 16 per cent of people in developed countries, such as the United States and Australia, skipping routine and pandemic vaccinations. 

Vaxxas’ HD-MAP technology solution leverages an ultra-high-density array of projections that is invisible to the naked eye to deliver vaccine to the abundant immune cells below the skin surface. This approach allows for a more efficient and effective immune response from the vaccine. 

All vaccine candidates applied to the Vaxxas HD-MAP are designed to be effective and easy to use while meeting industrial-scale manufacturing and commercial logistics requirements.