Submitted by Harold Saive

Chiron shrinks estimate of flu vaccine production (2005)

In 2004, contamination issues forced Chiron (a UK company) to cancel delivery of 48 million doses of flu vaccine, close to half the expected US supply.

Jun 16, 2005 (CIDRAP News) – Chiron Corp. has announced it won’t be able to provide as many influenza vaccine doses as previously estimated for the coming flu season, fraying a thread in the nation’s fragile vaccine supply web.

Chiron expects to supply 18 million to 26 million doses of flu vaccine in the United States this year, instead of the 25 million to 30 million doses projected in April, the company said in a news release yesterday.

Last year, contamination forced Chiron to cancel delivery of 48 million doses of flu vaccine, close to half the expected US supply. While working to recover its license, the company has experienced delays in start-up procedures and manufacturing problems usual in flu-shot production, the Chiron announcement said.

The problems include adjusting to more than 2,000 changes in the production process at Chiron’s plant in Liverpool, England, Chiron President Jack Goldstein told the San Francisco Chronicle. In addition, the company hired about 100 new employees to address quality-control issues, and part of the delay lies in training them, he added.

Federal officials and industry executives said that if Chiron does supply the reduced amount, there would be enough vaccine to prevent a severe shortage, according to a New York Times report today. But that assessment assumes that other companies will fulfill their projections.

Sanofi Pasteur expects to supply the US market with 50 million doses this year, plus a possible 10 million doses later in the season, according to the Times. Another 3 million doses of the intranasal vaccine made by Medimmune should be available as well, according to the Centers for Disease Control and Prevention (CDC).

In addition, GlaxoSmithKline is applying for approval to sell flu vaccine in the United States and may provide 10 million doses, the Times reported.

British regulators cleared Chiron in March to resume production of flu vaccine at the Liverpool plant. But the company still needs the US Food and Drug Administration’s approval to sell flu vaccine in the United States.

The FDA plans to inspect the plant in July to find out if problems identified last year have been corrected, the company said.

CDC spokesman Von Roebuck cautioned today that it is too early to draw any conclusions about the vaccine supply for the coming flu season.

”We’re not sure what exactly the news is and what it means for the coming season,” he told CIDRAP News. ”We’ll probably know a bit more by the end of August or the beginning of September, and that will help drive recommendations.”

Authorities are hoping to prevent a repeat of last year, when Chiron announced in early October that it would not be able to supply any of the promised 48 million doses. By that time, some vaccine doses from other manufacturers had already been shipped and used.

To cope with the resulting shortage, authorities identified priority vaccination groups and worked all season to move vaccine stocks to places where supply was low. Ultimately the United States obtained about 61 million doses, instead of the projected 100 million doses.

Dr. Jeanne Santoli, deputy director of the CDC’s immunization services division, told the Times that the CDC is planning for several scenarios this year, from a severe shortage to a surplus. If needed, she said, the agency could provide vaccine first to those in high-risk categories.

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