Baxter Healthcare SA announced that the Austrian Ministry of Health has entered into a preparedness contract with the company that contains an option to purchase 16 million doses of pandemic influenza vaccine, enough to vaccinate the entire Austrian population. The three-year agreement provides the Austrian MOH with future access to the company's cell-based vaccine production capacity in the event of an avian flu pandemic.
"We are proud to provide the advanced science and technology, manufacturing capability and other resources to assist the Austrian Ministry of Health in its efforts to protect citizens from the threat of a flu pandemic" said Joy Amundson, corporate vice president and president of Baxter's BioScience business.
Baxter also is under contract to supply two million doses of H5N1 vaccine to the UK Government. In addition, the company is working with the US National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to develop a cell culture-based H5N1 candidate pandemic influenza vaccine.
Last month Baxter announced preliminary results of a phase I/II clinical trial in 270 healthy adults with its inactivated wild-type H5N1 pandemic vaccine. Preliminary results from this trial suggest that the vaccine is well tolerated in humans. Most common side effects are injection site reactions, headaches and fatigue. In addition, the preliminary results suggest that the vaccine is highly immunogenic and elicits functional antibodies to H5N1 even at the lowest dose level of 3.75µg. 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. Importantly, preliminary analysis of serum samples obtained from the study subjects suggests both the neutralization of the pandemic virus contained in the vaccine and cross-neutralization against widely diverse strains of H5N1, including both Hongkong/156/97 and Indonesia/05/05.
Cell-based systems 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 the company's research and development work in Austria, Baxter has been successful in growing wild-type virus in its vero-cell culture, which means that the company could begin vaccine production without having to wait for high-growth or attenuated virus reassortants normally used when vaccine is produced in eggs. Baxter has one of the largest existing cell-culture facilities in the world, capable of manufacturing large quantities of vaccine. Because the facility is engineered for BioSafety Level III production, the facility can utilize wild type pandemic strains to help accelerate production and reduce the total time required to produce vaccine by several weeks. Baxter's technology platform also allows it to implement rapid changes in strains that may be needed for new vaccine formulations.