Flu Vaccinie Company shut down !!! YEA !!!

[Debbie]

Flu vaccine supply cut in half
Maura Lerner and Josephine Marcotty, Star Tribune
October 6, 2004 FLU1006
Health officials suddenly found themselves facing a major shortage of flu vaccine Tuesday after one of the leading manufacturers was ordered to halt the sale of millions of doses.

In Minnesota, the shortage will likely cause the cancellation of hundreds of flu clinics that had been scheduled to begin next week at supermarkets, doctors offices and many businesses.

Federal and state officials called on health organizations to start limiting the vaccine to people who need it most, such as the elderly, the chronically ill and children ages 6 to 23 months.

The manufacturer, Chiron Corp. of Emeryville, Calif., had been expected to ship at least 46 million doses of flu vaccine -- about half the nation's supply -- to U.S. clinics and health organizations.

Associate Press file
Syringes were loaded with influenza vaccine at a Chiron facility in Liverpool,...ApBut on Tuesday, British health officials suspended its license to produce the vaccine, Fluvirin, for three months, citing safety problems at a manufacturing plant in Liverpool, England.

The Liverpool plant supplies the U.S. market. The company announced it was canceling all shipments for the season.

"Really, it has caught everyone by surprise," said Kris Ehresmann, chief of the immunization program at the Minnesota Health Department.

The suspension occurred just a week after Chiron's Chief Executive Howard Pien assured Congress that he expected the shipments to be on track. The shipments had been postponed in August after testing found sterility problems in some batches of the vaccine. Last week, Pien testified that the problems involved only "a small number of lots."

On Tuesday, he called the suspension "unexpected and disappointing."

Tommy Thompson, the U.S. secretary of Health and Human Services, said the decision "creates a serious challenge to our vaccine supply for the upcoming flu season." Chiron is one of only two major manufacturers of the flu vaccine, along with the French-based Aventis.

Fewer doses

Thompson said the country will have about 54 million doses of flu vaccine, plus another two million doses of FluMist, a nasal spray vaccine. That's just two-thirds of the 85 million doses available last year, when supplies ran out. The government had hoped to increase the supply to 100 million doses this year.

Health officials said the limited supplies will go to those who need it most under a voluntary rationing system, in which most healthy people are asked to skip flu vaccinations.

"This is the first time we've ever asked people to not get vaccinated," said Ehresmann of the state Health Department.

About 36,000 people die of complications of the flu every year in the United States, and 200,000 are hospitalized.

In Minnesota, Chiron's largest customer for flu vaccine is the Minnesota Visiting Nurse Agency, which runs the flu clinics at Cub Foods and senior centers, as well as about 800 businesses. Mary Ann Blade, the group's president, said she had been expecting an order of 150,000 doses to arrive today from Chiron.

"We're in shock right now," she said after hearing the shipments were stopped. "And unfortunately, there is no other place to go for them."

She said the group will probably cancel most or all of its flu clinics.

State health officials said they are trying to find out how much vaccine will be available in Minnesota. Each health care organization buys directly from the manufacturers.

Many of the largest hospitals and clinic groups said Tuesday that they had ordered supplies from Aventis, not Chiron. That includes Allina Hospitals and its 42 clinics, HealthPartners, Children's hospitals, and Hennepin County Medical Center and its clinics. All said they would abide by the new vaccination guidelines, and would share their supplies with other groups if asked.

Deb Klein, pharmacy manager at United Hospital in St. Paul, said Allina switched to Aventis this year after running into technical problems with Chiron last year. "Turns out, that was a good decision," she said.

Although Chiron officials said they believe the sterility problem was limited to a few batches, British regulators took a different view, Pien said Tuesday. The government notified the company that its Liverpool plant did not meet British quality control standards. Even if the problems were resolved soon, company officials said, it would be too late to make more vaccine for this season.

Prof. Mike Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said he doubts the decision will be reversed. "On the whole, Great Britain did a good job of evaluating this," he said.

The reporters are at

mlerner@startribune.com and marcotty@startribune.com