After analyzing the results of patients who received Baxter's seasonal flu vaccine prepared in cell culture -- the company has concluded that it was at least as effective in preventing disease as alternative vaccines produced in the more traditional eggs. Baxter's vaccine prevented flu in 78% of patients who were vaccinated and the historic figure for egg-based vaccines is about 73%.
Cell-based vaccines offer a faster, more reliable alternative to vaccines grown in fertilized chicken eggs, a 60-year-old method that can take up to six months to complete and is prone to manufacturing problems that have led to vaccine shortages. In particular, cell-based methods can skip the 8 to 10 week step where the vaccine virus needs to be adapted to growth in eggs. This time savings can be a critically important factor in times of flu pandemic when vaccine stocks need to be raised quickly.
Baxter is in talks with the FDA about whether the data will be adequate to support licensure in the United States. It hopes within the next month that should be clearer. Baxter's cell culture vaccine is approved for sale in Austria and the Czech Republic, and Baxter expects broader licensure in most European countries by the end of March.
Posted by Bruce Lehr Feb 16th 2011.