OmniFlu™

One of the major challenges for the WHO, vaccine manufacturers, health systems and patients is predicting correctly and then selecting a single dominant virus strain to best represent each of the subtypes. Recently, strain selection match rates have been as low as 50%.

In fact, in the 12 influenza seasons from 2003/04 to 2014/15 in Europe, there were six years where at least one of the vaccine strains chosen did not match with the dominant circulating strain (see Table 1). In the USA over the same period there were eight seasons of mismatch.[1],[2] 

All of the influenza vaccines on the market are trivalent or quadrvalent which means they can – at best – include 3 or 4 strains in a single dose. This reduces their ability to provide the range of flu strains circulating. In six of the last 12 years, the virus strains chosen to represent the influenza subtypes have not matched the dominant strain. Increasing the number of strains, which can be delivered in a single dose would improve the match rate which would help save lives, reduce hospitalization and improve patient immunity.

OmniFlu™ is the world’s first omni-valent influenza vaccine capable of delivering 15 strains in a single dose. By including 15 strains in a single dose, Stabilitech estimates its new OmniFlu™ could raise match rates to 80%. The company estimates this could have saved over half a million hospitalizations, 6,000 lives and $15bn+ in direct and indirect costs in the USA in the 2014/15 flu season.

Stabilitech’s formulation platform also enables dramatic antigen sparing (the amount of virus required to elicit a protective immune response). It also reduces costs for vaccine manufacturers and healthcare systems.  OmniFlu™, therefore, represents a potential paradigm shift in the fight against influenza in a market forecast to be worth $4.3bn by 2025.

The opportunity

The influenza vaccine market is dominated by Sanofi Pasteur, Seqirus (CSL Behring), GSK and AstraZeneca. There is limited product differentiation to address an annual epidemic which afflicts up to five million people severely and causing up to half a million deaths. In the seven major pharmaceutical markets – US, France, Germany, Italy, Spain, UK, and Japan – sales of seasonal influenza vaccines grew from $2.6bn in 2012 to $3.1bn in 2015. This is forecast to grow to over $4.3bn by 2025 and more than 320 million people receiving a vaccination.

 

 


 

[1] Santos GD, et al., (2016) Influenza: can we cope better with the unpredictable? Human Vaccines & Immunotherapeutics. 12(3); 699-708;

[2] van der Werf & Levy-Bruhl (2015) Influenza – the need to stay ahead of the virus. Euro Surveill. 20(5)