The Austrian Ministry of Health entered into a preparedness contract with Baxter Healthcare 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.
Baxter also is under contract to supply two million doses of H5N1 vaccine to the U.K. Government. In addition, the company is working with the U.S. 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 in 270 healthy adults with its inactivated wild-type H5N1 pandemic vaccine suggesting 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 3.75 micrograms, according to Baxter.
A Baxter spokesperson explains that its 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, adds the Baxter official.