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http://www.nytimes.com/aponline/national/AP-Tainted-Flu-Vaccine.html
The New York Times
August 27, 2004

A Big Maker of Flu Shots Finds Some Contaminated
By LAWRENCE K. ALTMAN

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.



Related Stories:
http://money.cnn.com/2004/08/27/technology/chiron.reut/

http://www.reuters.com/aitoolkit/aitArticle.jhtml?type=hotStocksNews&storyID
=6082941




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