Wednesday, July 25, 2007

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

Wednesday, July 04, 2007

GlaxoSmithKline ready to work with Japanese drugmakers on bird flu vaccine

TOKYO: GlaxoSmithKline PLC is ready to work with Japanese pharmaceutical companies if the Japanese government agrees to stockpile the company's pre-pandemic vaccine for bird flu, the head of the company's vaccine business said Wednesday.

"We are in contact with all the local vaccine manufacturers" and the Japanese government to discuss the need to prepare for a possible bird flu outbreak among humans, said Jean Stephenne, president of GlaxoSmithKline Biologicals at a news conference in Tokyo.

Britain-based GlaxoSmithKline is one of the world's largest makers of vaccines and is calling on governments to stockpile pre-pandemic influenza vaccine to deal with outbreaks in their early stages.

If a bird flu pandemic hits, Japanese companies could manufacture vaccines using GlaxoSmithKline technology, while its adjuvant system could be applied to existing vaccines.

GlaxoSmithKline's adjuvant system can reduce the dosage from a vaccine for protection and assists in providing protection against similar strains of a virus, improving the chances of controlling mutated versions of the H5N1 bird flu virus, according to Stephenne.

Japan's vaccine market is tightly closed, and major vaccine makers are government-affiliated organizations that don't have very strong funding or research capabilities.

Japan's vaccine development guidelines also differ from those of other major markets and the World Health Organization, making it difficult to import vaccines made overseas. (The Associated Press)


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