In excess of 1 bn fertilised specific pathogen free (SPF) chicken eggs are used annually in vaccine manufacture, globally. Eggs play a central role in production of vaccines like flu, yellow fever, smallpox, monkey pox, measles and mumps where a virus is grown in the developing embryo of fertilized eggs. The COVID-19 pandemic has increased an already high global demand for vaccines: while the success of mRNA vaccines may lead to development of future vaccine technology, it is expensive and has a complex supply chain. Traditional vaccine production will continue to play a dominant role in the world’s vaccine strategy, as the methods and infrastructure are well established.
SPF is the term that is used to describe eggs, which are confirmed to be free of various infectious agents e.g. bacteria and viruses. The embryo in the egg is used to grow the virus, the basis of the development and production of vaccines. Globally, there is a world shortage of ‘high grade’ eggs for vaccine manufacture and ongoing supply and contamination issues dictate a need for a superior product. Currently, all eggs used in vaccine manufacture, even those of the highest SPF grade, carry bacteria on the shell and up to 30% of eggs carry bacteria inside the shell. Internalised bacteria cannot be removed without damaging the embryo, rendering it of no use for vaccine production.
Bacterial contamination occurs because the eggshell may absorb contaminating bacteria, from external sources. An eggshell is porous to facilitate gaseous exchange by the growing embryo. The pores of the eggshell are vulnerable to bacterial ingress during laying and for approximately 5 minutes after the egg is laid. Unlike mammals, where the digestive tract is separate from the reproductive tract, in poultry, the reproductive tract merges with the digestive tract, in the cloaca, and there is a single point of exit from the hen for eggs and faeces. This results in the porous egg coming in contact with the chicken’s faeces prior to being laid and consequent contamination of up to 30% of the eggs within the shell occurs. Detection of infectious agents relies on microbiological monitoring but the 4-week lag time required to confirm the presence of infection in the SPF eggs, means that infected eggs will have already been used in vaccine production, causing rejections of batches of vaccines, delays to market and delays to patient vaccinations. It only takes one contaminated egg to destroy a batch of vaccines. The cost of a rejected batch of vaccine can be up to $480,000 with annual losses of $35 million confirmed by one global vaccine manufacturer visited during our extensive market research.
Following 7 years of R&D and solving many intractable problems Ovagen has developed its innovative and disruptive technology to produce the world’ first germ free eggs which will be a game changer for vaccine manufacture. Germ free eggs will transform vaccine production by:
-eliminating bacterial contamination and reducing antimicrobial resistance, a holy grail for vaccines
-increasing the yield of vaccines produced per egg
-increasing quality, security and sustainability
-reducing carbon footprint
-allowing more efficient and cost effective production of vaccines therefore improving access for poorer Nations.
The overall objectives of this project was to radically transform the way egg based vaccines are manufactured globally and to offer an additional solution to the rapid development and manufacture of vaccines in the case of future pandemics.
