- The Washington Times - Friday, October 8, 2004

The Food and Drug Administration is unlikely to clear influenza vaccine made by Chiron Corp. as safe for Americans to use this flu season, Dr. Lester M. Crawford, the agency’s acting commissioner, said yesterday.

It was not clear whether the lack of vaccine might lead to more flu deaths this year. Dr. Crawford and Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, sidestepped such questions at a House Government Reform Committee hearing. In a typical year, an estimated 36,000 Americans die of the flu.

Jim Young, president of research and development for MedImmune Inc., which makes an alternative flu treatment available to a limited population of healthy people, testified that any spike in the death toll largely hinges on whether scarce flu vaccine makes its way to those most at risk. They include those with impaired immune systems, such as the young, the elderly and people with medical conditions.

The CDC was asking healthy adults to forgo flu shots or to use MedImmune’s FluMist if they are within the 5- to 49-year-old age range for that product.

But Mr. Young later testified that the National Institutes of Health was advising employees in its hospitals not to take FluMist.

“The agencies are putting out mixed messages,” Mr. Young said.

MedImmune said yesterday it plans to nearly double the number of doses of FluMist it will produce this year.

The Gaithersburg company had made 1.1 million doses for this flu season, following a disappointing first season last year for the drug.

The company will now use bulk supplies of the prescription vaccine to put together nearly 1 million more doses, according to spokeswoman Clarencia Stephen. The extra FluMist could be available to the public by late November, she said.

Dr. Crawford’s pessimism about the Chiron vaccine came as FDA officials in England met with Chiron officials and were poised to begin an in-depth inspection of the company’s Liverpool vaccine-production facility over the weekend.

Asked if the FDA was likely to coax free 40 million impounded doses of flu vaccine that Chiron testing indicated were free of contamination with bacteria, Dr. Crawford said, “It’s not possible to say if any of them are salvageable at this point. I have to present to you a pessimistic point of view.”

He told reporters afterward that the FDA probably would have made the same decision its British counterparts did: suspending Chiron’s vaccine production and exports due to manufacturing problems. The decision, announced Tuesday, halved the U.S. flu vaccine supply.

Much of yesterday’s discussion underscored the frailty of the nation’s supply of dispensable vaccine and the scant number of manufacturers producing it.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said manufacturers can make higher profits with blockbuster drugs that patients take regularly. He said a year’s supply of Lipitor costs $1,608 versus $3,500 for Viagra. The price of a year’s supply of flu vaccine: $7 to $10.

“We need to help with incentives,” Dr. Fauci told the committee.

Christine Grant of Aventis-Pasteur — which is supplying 55.4 million doses of flu vaccine for Americans this year — cautioned against the government taking over vaccine manufacturing. She said a government-controlled operation would be an unfair competitor. Government takeover “is the quickest way to chill private investment,” she told reporters later.

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