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U.S. Loses Half Its Flu Vaccine Supply
48 Million Expected Flu Vaccine Doses Lost as Factory Loses License

By Daniel DeNoon
WebMD Medical News Reviewed By Michael Smith, MD
on Tuesday, October 05, 2004

Oct. 5, 2004 -- Expect flu vaccine shortages again this year. Manufacturing problems mean half the U.S. flu vaccine supply -- 48 million doses -- won't arrive.

The U.S. gets nearly all its flu vaccine doses from two manufacturers, Chiron Corp. and Aventis Pasteur.

Last August, Chiron announced that manufacturing problems resulted in contamination of some early lots of its vaccine. Correcting these problems, they said, would delay vaccine delivery.

It now turns out that those problems were quite serious. British authorities have found Chiron's manufacturing process unacceptable and have temporarily suspended the manufacturing license at its Liverpool plant, preventing the company from releasing any of its product this season, according to a Chiron news release.

"Chiron deeply regrets that we will be unable to meet public health needs this season," Chiron CEO Howard Pien says in the news release.

Public health officials are reacting to the news with dismay. One of them is Harry Keyserling, MD, professor and director of the division of pediatric infectious diseases at Emory University.

"This is certainly a significant and shocking problem to find out that one of the major vaccine producers is not going to be able to release any of its vaccine this year," Keyserling tells WebMD. "Flu season usually peaks in January or February. If no additional vaccine is available for several months, it is unlikely that the flu season will wait."

Expecting to have 100 million doses of flu vaccine on hand, the CDC has been telling everybody to get a flu shot. Now the public health agency is scrambling to come up with new recommendations.

"We may have to restrict flu vaccination this year to high-risk groups: the elderly, people with certain medical conditions, and children between 6 months and 23 months of age," Keyserling says.

Keyserling notes that the Chiron vaccine is not approved for small children, so pediatric vaccine doses may not be as severely affected as those for adolescents and adults.

A third manufacturer, MedImmune, makes a nasal-spray flu vaccine. But it wasn't a big seller last year. This year, MedImmune is making only 1.5 million doses. Aventis Pasteur is still expected to deliver 52 million doses of its vaccine.

Altogether, this means the U.S. will have 53.5 million of an expected 101.5 million doses. Last year, Americans used nearly all of the 84 million available doses.

If flu vaccine availability is indeed restricted, the following groups of people are those who should first get the vaccine:

a.. Kids with asthma
b.. Kids aged 6-23 months
c.. People over age 50
d.. Anyone with long-term health problems
e.. Health care workers and their immediate families
f.. People with weakened immune systems
g.. Children on long-term aspirin treatment
h.. People in nursing homes

SOURCES: News release, Chiron Corp. Harry Keyserling, MD, professor and director, division of pediatric infectious diseases, Emory University, Atlanta. CDC.

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