Pandemic influenza occurs when a new virus emerges that is easily transmitted among humans and causes serious illness, which can result in a worldwide outbreak of disease, or pandemic.
Avian influenza, or bird flu, does not normally infect humans, but there have been several examples in the last few years of transmission to people, leading to fears of a strain with the potential to lead to a pandemic.
The World Health Organization (WHO) classifies the current global situation as a level 3 pandemic alert – on a one to six scale where six is pandemic.
The three-year deal signed with Baxter provides the Austrian ministry of health with future access to the company's cell-based vaccine production capacity in case a pandemic influenza hits the country.
Cell-based systems, like the one used by Baxter, for production of vaccines offer a number of potential benefits over more traditional, chicken egg-based systems. Baxter's vero-cell system is capable of producing high yields of influenza virus without the addition of any animal-derived serum.
Through its research and development work in Austria, the company has been successful in growing wild-type virus in its vero-cell culture, which means that the company could begin vaccine production straight away without having to wait for high-growth or attenuated virus reassortants normally used when vaccine is produced in eggs.
Furthermore, The Austrian drug company is also under contract to supply two million doses of H5N1 vaccine to the British Government. The vaccine is intended to protect people against a strain of avian influenza called H5N1 that is spreading in Asia, Africa, the Middle East, and parts of Europe, and that could potentially lead to a global pandemic.
In addition, the company is working with the US National Institute of Allergy and Infectious Diseases to develop a cell culture-based H5N1 candidate pandemic influenza vaccine.
Last month Baxter announced preliminary results of a phase I/II clinical trial of its inactivated wild-type H5N1 vaccine showing a good tolerance in humans.
What is more, the initial results suggest that the vaccine is highly immunogenic and elicits functional antibodies to H5N1 even at the lowest dose level of 3.75 micrograms. The company said that these preliminary data, which must be confirmed in a larger study, suggest that the vaccine may provide wider protection for a larger number of people before and during a pandemic.
Baxter has one of the largest existing cell-culture facilities in the world, capable of manufacturing large quantities of vaccine, the company said.
The firm claims its facility utilises wild type pandemic strains to help accelerate production and reduce the total time required to produce vaccine by several weeks.
This new contract for Baxter comes days after the US government signed contracts totalling almost $200m (€155m) with Novartis, Sanofi Pasteur and GlaxoSmithKline for 5.3m doses – two doses make up one vaccination.
source - Outsourcing Pharma