A light flu season, more vaccine ease worries

WASHINGTON -- Government health officials gave an upbeat flu report Wednesday, telling Congress that early signs point to a light flu season and that 5 million additional doses of flu vaccine may soon be available.

Julie Gerberding, director of the Centers for Disease Control and Prevention, said the flu season has been so light that some states have yet to report an outbreak. However, she warned that the worst months for the virus lie ahead.

U.S. officials had planned on a 100 million-dose supply for the 2004-5 flu season but were left with only 54 million to 56 million doses after a bacterial contamination led British regulators to shut down Chiron Corp.'s Liverpool, U.K., vaccine manufacturing plant on Oct. 5. Gerberding said 10.3 million vaccine doses remained to be distributed as of Nov. 9.

With the U.S. supply cut in half, health officials launched a program to limit distribution of the vaccine to groups considered most vulnerable to the disease: seniors, children and those with weak immune systems.

Gerberding reported early success in this effort, telling the lawmakers that a CDC survey shows that 26 percent of high-risk Americans have received flu shots. This is a normal rate for this time of year, she said, while only 4 percent of healthy adults are immunized against the virus.

Lester Crawford, acting Food and Drug Administration commissioner, said additional production from Aventis Pasteur -- the only remaining U.S. flu shot supplier -- has pushed the year's total supply up to 61 million, and that his agency may soon approve an additional 5 million doses imported from Canada and Europe.

Officials from the state of Illinois and the City of New York found an additional 750,000 doses when they searched wholesale markets in Europe. Those doses are currently being examined to determine if they are safe for use, Crawford said.

Rep. Tom Davis, R-Va., the chair of the House Government Reform committee who flew to England last week to meet with British regulators and Chiron officials, said he's "optimistic" that the company will be able to fix problems at its Liverpool plant in time to manufacture next year's supply. The company has already begun the early steps in manufacturing the vaccine, which involves the growth of the flu virus inside chicken eggs and takes months to complete.

Crawford said he is working with British officials and Chiron to bring the Liverpool plant up to regulatory standards for next year's supply. He also said the FDA is urging other potential flu shot manufacturers to apply for U.S. approval to produce the vaccine.

Committee Democrats hammered Crawford and the FDA for failing to detect the contamination before British regulators closed the plant. Rep. Henry Waxman, D-Calif., the top Democrat on the committee, said the FDA's discovery of similar bacterial contamination at Chiron's plant in June 2003 should have led to increased scrutiny of Chiron's supply this year.

When Chiron alerted the agency of this past summer's bacterial contamination, Waxman said the FDA should have immediately sent inspectors to the Liverpool plant. Instead, the FDA relied on Chiron's own investigation into the matter.

Crawford responded that Chiron's vaccine supply in 2003 was safe for use and insisted that the two contaminations were "entirely unrelated."

Waxman, though, pointed to internal FDA documents that he said showed that FDA inspectors had told Crawford last month that the 2003 contamination directly led to this year's shut down.

Waxman charged that the Bush administration intentionally misled Congress and the American public about the agency's failures leading up to the Nov. 2 election.

Committee Republicans came to the agency's defense. Davis insisted that "it would be inappropriate to imply" that the 2003 bacterial contamination contributed to this year's closing of Chiron's plant.

Rep. John Mica, R-Fla., said the real issue was the threat of tort lawsuits that drive vaccine manufacturers from the U.S. market. Waxman called the liability issue a "red herring."

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