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[ Subject: A Big Maker of Flu Shots Finds Some Contaminated
[ From: fidyl@yahoo.com
[ Date: Thu, 2 Sep 2004

A Big Maker of Flu Shots Finds Some Contaminated

By Lawrence K. Altman
August 27, 2004

http://www.nytimes.com/2004/08/27/health/27flu.html

The Chiron Corporation, a major manufacturer of influenza
vaccine, said yesterday that it had detected a
contamination problem in its new supply and was delaying
release of nearly 50 million doses until scientists could
determine the cause.

Chiron makes about half the 100-million-dose supply that
federal health officials expected to be used this flu
season. Its chief executive, Howard Pien, said in a
telephone interview that it informed the Food and Drug
Administration and the Centers for Disease Control and
Prevention about the problem on Wednesday. Other than a
relatively small amount sent to distributors in July, Mr.
Pien said, the company will probably not begin issuing
the vaccine until mid-October, about a month later than
expected.

Chiron's disclosure to the government agencies came on
the very day the Bush administration released the
nation's first plan of preparation and response involving
the next pandemic of influenza. In that plan, still in
draft form, the government underscores a need to help
industry improve the production of influenza vaccines for
the ordinary seasonal outbreaks as well as for a
pandemic.

Dr. Julie L. Gerberding, the director of the disease
control centers, said Chiron's contamination problem was
"not good news," in part because the usual October flu
immunization clinics may need to be postponed until
November.

But given what Chiron has told her, Dr. Gerberding said
in a phone interview, "at this point we don't anticipate
an overall shortage.'' As a result of that expectation,
she added, the C.D.C. is not now changing its
recommendations as to who should be immunized.

There are 185 million Americans who ought to be immunized
under this year's recommendations, which, for the first
time, advocate giving the vaccine - two doses, in fact -
to all infants from 6 months to 23 months.

In a usual flu vaccination season, most shots are given
by Thanksgiving. But a number of public health experts
expressed concern yesterday that the delay caused by the
Chiron problem would complicate such efforts, because
they require considerable planning. The experts said they
worried that Chiron was offering a best case.

"It's a mess," said Dr. William Schaffner, chief of
preventive medicine at Vanderbilt University. "This will
lead to striking disparities in flu vaccine availability
around Your Town, U.S.A.''

"If anything,'' Dr. Schaffner said, "this emphasizes the
importance of the pandemic plan and the need for more
vaccine manufacturers and new immunization techniques.''

Mr. Pien, Chiron's chief executive, said he did not
foresee a widespread problem for his company's product,
Fluvirin, because, he said, only 8 of 60 batches tested
so far have failed to meet the manufacturer's sterility
specifications.

"This should have a minimum impact on the American
population," he said.

Nevertheless, "no assurances can be given that additional
tests on Fluvirin will yield satisfactory results or that
Chiron will be able to release Fluvirin this season," the
company said in a news release.

Chiron (pronounced KY-rohn), based in Emeryville, Calif.,
outside Oakland, manufactures the vaccine in Liverpool,
England. Its quality controls cover a wide range of
tests, said Mr. Pien, who declined to specify which of
those the eight contaminated Fluvirin batches had failed.
He said the contamination was biological in nature and
possibly due to human error, but again would not be more
specific.

The four million doses in the eight batches will be
destroyed, Mr. Pien said. He said that though Chiron
shipped the first one million doses of Fluvirin to
distributors in July, they had not been distributed to
doctors and clinics.

Mr. Pien said he thought the company would be able to
release the rest of its full complement - from 46 million
to 48 million doses -by mid-October. Though that would be
about a month later than expected, he said, it would
still be in time to meet public health needs for this
influenza season.

Chiron is manufacturing about 25 percent more vaccine
than it produced last season.

A second major manufacturer, Aventis, said it was ahead
of schedule in producing more than 50 million doses. A
spokesman for the company said it was surprised by
Chiron's announcement and planned to determine whether
Aventis could make more vaccine and, if so, how soon.

A third manufacturer, Medimmune, plans to manufacture
from one million to two million doses of its FluMist, an
influenza vaccine that is sprayed into the nose.

Denise Grady contributed reporting for this article.

End of forwarded message from fidyl@yahoo.com

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