Government seeks genetic blueprint for human and bird flu viruses

WASHINGTON (AP) _ Chiron Corp. has asked British regulators to inspect its facility producing an experimental bird flu vaccine to make sure it doesn't run into the same contamination problems that

Monday, November 15th 2004, 1:14 pm

By: News On 6

WASHINGTON (AP) _ Chiron Corp. has asked British regulators to inspect its facility producing an experimental bird flu vaccine to make sure it doesn't run into the same contamination problems that forced the closing of another plant and a flu shot crisis in the United States, a top U.S. health official said Monday.

The company was to have supplied half of the nation's flu vaccine this year. Its inability to do so was an issue in the presidential campaign, prompted government investigations, sparked a congressional inquiry and raised concerns about its production of the experimental bird flu vaccine.

The inspection of its second Liverpool facility, where 10,000 doses of bird flu vaccine are being produced for use in clinical trials, is expected to occur before Christmas.

``They asked to be inspected,'' said Dr. Anthony Fauci, director of the national Institute of Allergy and Infectious Diseases.

Asked whether U.S. officials would more aggressively inspect the plant, Fauci said, ``I can't speak for the FDA,'' the Food and Drug Administration.

Chiron is one of two companies producing experimental bird flu vaccine. Aventis Pasteur also has received a federal contract to produce 8,000 pilot lots. More importantly, Aventis scored a government contract to produce 2 million doses of vaccine to treat the strain of bird flu blamed for killing 32 of the 44 humans infected in Thailand and Vietnam this year.

The preparations come in anticipation of the next flu pandemic.

Fauci told reporters on Monday that researchers don't expect that dire predicament this year. The bird flu, while lethal, has not proven agile in leaping from human to human. But a pandemic will eventually strike this nation, he said.

``We're due for it,'' he said.

His comments came during a wide-ranging National Institutes of Health round-table on new developments in influenza research. Scientists are working on such know-how as developing a vaccine that would give long-term flu protection, eliminating the need for annual shots, and speedier ways to produce flu vaccine.

In addition, the government will try to predict the influenza virus's next moves by sequencing genomes for thousands of known human and bird flu viruses, a project that could help researchers understand how the flu constantly evolves.

Around the globe, the flu kills up to 500,000 people each year. In the United States, the death toll in a typical year is 36,000, with 200,000 suffering severe enough infections to be hospitalized. The price tag of flu and pneumonia _ one of the opportunistic ailments that afflict people weakened by the flu _ is estimated at $37.5 billion.

The biggest global payoff for the genetic sleuthing: learning how bird flu hops with ease from chickens to humans. Global researchers are chilled by the prospect that a human sick with the regular flu could get the bird flu, becoming a human petri dish that allows a new virus to evolve for which there are few treatments.

The H5N1 strain that is racing through Asia, killing dozens of humans and prompting the destruction of millions of birds, constantly mutates.

This year, the Department of Health and Human Services is slated to spend $215.6 million on flu-related research and actions. In the 2005 fiscal year, the agency's spending on flu is expected to rise to $283.1 million. Of that total, the NIAID expects to spend $57.9 million on vaccine and drug development and basic research that would, among other projects, lead to a nasal spray for bird flu.

The government has tried to deal with the loss of 46 million to 48 million doses of flu vaccine from Chiron Corp. by going to other suppliers and looking for surplus around the globe.

In the long term, the government is working to entice manufacturers back into the flu vaccine game by eliminating red tape, providing tax incentives and ensuring the government will step in to purchase unused flu vaccine at a fair price, Fauci said.