Baxter says trial on new flu shot promising

Baxter International Inc., working to modernize the production of influenza vaccines, this morning said its seasonal flu product is showing "strong antibody responses and good tolerability" in an early stage clinical trial in humans.

Although Baxter is still several years from winning approval of the product, the study shows Baxter's reformulated seasonal flu vaccine is tolerable. In late 2004, Baxter had to suspend final-stage human sudy of its seasonal flu vaccine because it was causing fevers in some patients.

The Deerfield-based medical product giant is trying to develop a flu vaccine produced with cell tissues, which is a method that would allow manufacturers to quickly brew vaccine by the vat and likely eliminate shortages like the one that rattle U.S. consumers and health-care providers from time to time.
The cell-based approach is a sharp contrast to the tedious, 1940s method still used today that involves hand-processing millions of chicken eggs in labs. For each dosers shine a light through the shell of an egg to find the fluid surrounding an embryo, inject a strain of the flu virus and let it incubate for several months.

The current method is a long months-long process fraught with risk, while cell-based vaccines are more consistent and could be produced in as little as nine to 12 weeks.

In the latest clinical trial, Baxter said more than 900 patients were studied. Baxter said the preliminary data show its cell-based seasonal influenza vaccine's "tolerability profile" to be similar to egg-based seasonal flu vaccines on the market. There were, however, some side effects that included headaches and some injection site reactions, Baxter said.

Baxter is building momentum for its vaccines business. The company is also in the final stages of testing for a vaccine against strains of the Avian influenza, also known as the bird flu and is working with governments around the world interested in stockpiling the product in the event of a pandemic outbreak. Chicago Tribune


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