OraPro-Flu™

One of the major challenges for the World Health Organisation (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 when responding to seasonal influenza. 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 same period in the USA, there were eight seasons of mismatch.[1],[2]

All current influenza vaccines on the market are trivalent or quadrivalent which means they can – at best – include three or four strains in a single dose. This limits the scope of biopharmaceuticals to combat the full range of flu strains circulating. In six of the past 12 years, the virus strains chosen to represent the influenza subtypes have not matched the dominant strain. Increasing the number of strains that can be delivered in a single dose would improve the match rate. This would improve patient immunity, reduce hospitalisation and help save lives.

OraPro-Flu™ from Stabilitech is the world’s first omni-valent influenza vaccine, capable of delivering 15 strains in a single dose and with the potential to raise match rates to 80%. Match rates at this level could have saved over half a million hospitalisations, 6,000 lives and over $15bn in direct and indirect costs in the USA during the 2014/15 flu season.

Stabilitech’s OraPro platform enables omni-valence against the flu virus through incorporating multiple influenze antigens within a single capsule. By presenting a broader range of influenze antigens, OraPro-Flu minimises the potential for vaccine-strain mismatches.

OraPro-Flu 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 causes severe health issues for up to five million people and is responsible for 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 as more than 320 million people receive 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)