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Updated: 02:56 PM EDT
Officials Warn of 'Significant Shortage' of Flu Vaccine
By EMMA ROSS and MARILYNN MARCHIONE, AP

LONDON (Oct. 5) -- 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.
American vaccine experts suggested shots this year would likely be rationed.

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

Howard Pien, president and chief executive of the California-based company,
said safety tests on its vaccine were nearly complete, safety concerns seemed
to be resolvable, and the company had been talking with the U.S. Food and Drug
Administration and its British counterpart about shipping its vaccine.

''The FDA were generally comfortable,'' but the British agency ''has come to a
different conclusion,'' Pien said.

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 now even
that won't be made available because of the British safety concerns.

Pien again refused to identify the contaminant in Chiron's vaccine but said,
''It relates to what amounted to human error in a relatively late step in a
fairly complicated series of manufacturing procedures.''

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.

Dr. Walt Orenstein, formerly the top flu expert at the U.S. Centers for Disease
Control and Prevention and now the associate director of the Emory Vaccine
Center, said the government may have to ration available vaccine.

''It's a very serious concern. We're already in October, which is vaccine
season. If we have to ration at this stage, it becomes more complicated.''

If problems prevent the Chiron vaccine from being used at all this year, it's
unlikely that other manufacturers could fill the gap. Aventis Pasteur, which
expects to supply 52 million doses, said earlier that federal officials had
asked it to make additional vaccine but that it already was at capacity and
couldn't produce more until after November when existing orders are filled.

A third manufacturer, MedImmune, which makes FluMist, a new nasal spray flu
vaccine for use in healthy 5- to 49-year-olds, said it couldn't produce more
than the 1.5 million doses it had planned to make for this year's flu season.

That vaccine is made from modified live virus and isn't considered safe for the
elderly or people with medical problems.

Worldwide, Chiron is the second leading flu vaccine manufacturer, behind French
pharmaceutical company Aventis, which makes about 45 percent or 50 percent of
the world's supply, Stohr said.

Chiron, based in California, makes four influenza vaccines, including Fluvirin,
the top flu vaccine in Northern Europe and the No. 2 vaccine in the United
States.

The company also has facilities located throughout Europe, the United States
and Asia. Fluvirin is also made in the company's plants in Italy and Germany,
but those doses have already been promised.

Chiron Corp. officials cut the company's expected profits by more than half
Tuesday. Trading in Chiron's stock on the Nasdaq Stock Market was temporarily
halted Tuesday morning. Share price dropped $7.69 a share, or 17 percent, to
$37.73 after trading resumed.

''Chiron deeply regrets that we will be unable to meet public health needs this
season,'' Pien said. ''What happened was unexpected.''

The timing of the license suspension is particularly worrying because vaccine
production goes in cycles. The manufacturing cycle for the Northern Hemisphere
vaccine finished in August and manufacturers are now gearing up to make the
shots for the Southern Hemisphere.

Vaccine makers do not have a lot of spare stock because they produce on demand.

10/05/04 14:36 EDT