- The Washington Times - Wednesday, October 6, 2004

The U.S. supply of flu vaccine was cut in half yesterday, meaning that more than 40 million Americans could be unable to get a flu shot this year.

The world’s second-leading maker of the vaccine had its license suspended yesterday, but federal health officials said the nation does not face a public-health crisis.

“We have faced shortages in the past, and we have worked through them,” Health and Human Services Secretary Tommy G. Thompson said.

With flu season beginning, British officials suspended the license of Chiron Corp. for three months. Only three companies produce flu vaccine for the United States.

Some of the vaccine produced by Chiron at its Liverpool, England, facility was contaminated by bacteria, said Jesse Goodman, director of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research.

The U.S. Centers for Disease Control and Prevention (CDC) said in August that it expected to have 100 million doses of flu vaccine this season, and federal health officials began encouraging people to get flu shots less than two weeks ago.

Health officials now expect 54 million doses to be available.

They said they are working to ensure that young children and the elderly get vaccinated and are urging healthy adults not to get flu shots.

Health departments throughout the Washington area said they were waiting for direction from states and the CDC about their flu programs.

“Every year, we do prioritize the flu vaccines we get for people at the highest risks, and that is what we will do this year,” said Elissa Laitin, spokeswoman for Arlington County Human Services.

She would not say how many flu shots the county expected to administer.

Fairfax County’s Health Department ordered 5,000 adult doses of the flu vaccine, said spokeswoman Kimberly Cordero. In addition, the department had ordered 3,000 doses for children. The county is waiting on directions from the state but plans to administer the vaccine to high-risk residents.

Lucy Caldwell, spokeswoman for the northern region of the Virginia Health Department, said the state gets the majority of its flu vaccines from Chiron. The state is working with federal and local authorities.

Virginia had ordered 110,000 adult doses from Chiron, Ms. Caldwell said. The state ordered 115,000 children’s doses from Aventis-Pasteur, the biggest provider of vaccines.

Montgomery County health officer Dr. Ulder Tillman said the shortage has cut deeply into the county’s available doses for adults.

“We are able to get doses for children, but we don’t have doses for adults,” Dr. Tillman said.

Montgomery County will start its program to administer flu vaccines to high-risk children on Monday.

The Anne Arundel County Department of Health canceled all of its flu clinics and is waiting on directions from Maryland and the federal government.

The D.C. Health Department will be affected by the shortage, but spokeswoman Karyn Berry would not give any specifics.

“We are working with our partners to make vaccine available to priority groups,” she said.

Giant Food and Safeway officials say they are continuing with their planned vaccination programs. Giant spokesman Barry Scher advised customers to call the store’s pharmacy before coming in.

Ideally, about 180 million people would get vaccinated this season, CDC Director Dr. Julie Gerberding said. But far fewer people get a flu shot each year.

Everyone should “take a deep breath and recognize that this is not an emergency,” Dr. Gerberding said.

The CDC, which recommends that people get flu shots in October or November, says there are an average of 36,000 flu-related deaths annually.

Even as health officials urged people to remain calm, they said the country needs more companies producing that flu vaccine. Mr. Thompson also pleaded for more money to fund research into new methods to produce the vaccine.

Chiron, based in Emeryville, Calif., had planned to send 46 million to 48 million doses of flu vaccine to U.S. hospitals and clinics from its British facility, which is the only plant making vaccine for the United States. Only French firm Aventis-Pasteur produces more flu vaccine.

Chiron said yesterday it knew that there was a problem with contamination, but it thought it had fixed the problem and had planned to begin shipping.

“We believe … the problem was confined to a limited number of lots,” Chiron President and Chief Executive Howard Pien said. “Therefore, today’s actions by [British officials] is unexpected and disappointing. But we respect the regulatory authority’s judgment because we believe it is fundamentally based on concerns with safety.”

Chiron thought only 4 million doses were contaminated.

U.S. officials, who have known about problems at Chiron since at least August, said they expected 6 million to 8 million doses to be withheld, and they worked furiously yesterday to deal with the surprising announcement that British regulators suspended the company’s license.

Acommittee of U.S. health officials — the Advisory Committee on Immunization Practices — met yesterday and urged healthy adults not to get a flu shot. The vaccine should be preserved for children 6 months to 23 months old, adults 65 and older, pregnant women, anyone with a chronic illness, health care workers who come in contact with the elderly and ill people, nursing-home residents and anyone who cares for or lives with babies younger than 6 months old, the group said.

Health officials said they must determine whether Aventis-Pasteur can increase production in time to address the shortage. Aventis-Pasteur has shipped more than 30 million of the 52 million doses it had planned to provide this year.

The company may be able to dilute the vaccine to make it available to more people. A study several years ago by the National Institutes of Health concluded that diluted doses still could benefit healthy people.

“I want to underscore that this is something that is just being considered,” said Dr. Anthony Fauci, the National Institutes of Health’s allergy and infectious diseases chief.

MedImmune Inc., in Gaithersburg, sells the only other flu vaccine approved by U.S. regulators, and it will have 1 million to 2 million doses of FluMist this year. But only healthy people age 5 to 49 can take FluMist.

MedImmune can’t boost production.

“It’s not as simple as producing it when you need it, on demand,” spokeswomanClarencia Stephan said.

It is not clear whether there will be more cases of the flu — or more deaths — because fewer doses of flu vaccine are available, Dr. Gerberding said.

Chiron shares plunged $7.44, or 16.3 percent, to $37.98 on Nasdaq.

• Marguerite Higgins and Donna De Marco contributed to this report.

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