Flu vaccine maker's shipments suspended, raising fears of flu shot shortage at start of season

Published: Tuesday, Oct. 5 2004 12:02 p.m. MDT

LONDON — Global and U.S. health officials warned Tuesday of major flu shot shortages after British health officials abruptly pulled the license of the maker of half the U.S. vaccine just as flu season was about to begin.

The news means the United States will face "a significant shortage," said Dr. Anthony Fauci, the National Institutes of Health's infectious disease chief.

Other countries will likely face similar problems.

"The implications may be significant," said Dr. Klaus Stohr, influenza chief the World Health Organization.

British authorities suspended the license of Chiron Corp. for three months because of problems at its vaccine manufacturing plant in Liverpool, England. The action means the company can't supply any flu vaccines to any market during that time, and Chiron said it would provide no vaccine this year.

British officials didn't explain details for the license suspension.

Chiron officials said the British action came because of broad concerns about standards at the Liverpool factory, not just worries about the safety of already produced vaccine.

The company has no obligation to recall or withdraw any vaccine, but none has been released anywhere, and none will be this season, Chiron officials said.

U.S. health officials were caught off-guard, learning of the developments only during a midmorning phone call. "We need to regroup," Fauci said shortly afterward.

Chiron had planned to ship 46 million to 48 million doses, but that already had been delayed by a contamination problem discovered in August in the English factory where the vaccine is made. At the time, the company said only 4 million doses were tainted but that the entire supply would be held up and re-tested.

About 1 million doses already had arrived in the United States, but it remains under Chiron's control and has not been released for use.

Flu shot campaigns usually start in October, a month before the flu season typically begins in the United States. In an average year, flu kills 36,000 Americans and hospitalizes another 114,000, mostly the elderly.

Less than two weeks ago, top U.S. health officials assured the public that close FDA monitoring of the rest of Chiron's supply suggested it was fine and that there would be plenty of supplies.

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