Officials Face Off on European Flu Vaccine

Nov. 14, 2004 — -- From the sunny south to the chilly north, lines of those waiting outside clinics for flu shots may be slightly shorter this weekend because of the mathematical reality: There still is not enough vaccine for everyone, not even for those most vulnerable to the flu.

"It's a disgrace," says an elderly woman, 177th in line outside the Chelsea Clinic in New York City.

This week in Congress, there will be a hearing on the shortage with testimony from the head of the Food and Drug Administration. But the hearing is unlikely to produce more vaccine.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health says that so far flu vaccine doses in the United States number 61,000,000 out of an expected demand for 100,000,000 doses.

The shortfall is the result, in part, of contamination at a Chiron factory in Britain, which shut down production. Chiron is one of two main suppliers to the United States -- a fact, says Fauci, "which has put us in the difficult position of having to face a flu season with about one half of the doses we expected."

Imports From Europe?

In Illinois, that prospect has alarmed Gov. Rod Blagojevich.

"Senior citizens in hospitals, men and women with suppressed immune systems, men and women suffering from cancer, are at great risk because of the shortage of flu vaccine," he says. "More than 150,000 people here in Illinois were put at great risk."

So Blagojevich is spearheading an effort to import flu vaccine directly from Europe. It is an offshoot of an Illinois program to import other medicine at a lower price than the same medicine would cost in the United States.

"We were lucky enough to have a built-in infrastructure already in place," he says.

Illinois has purchased 300,000 doses and the program will also provide 150,000 doses for New Mexico and 200,000 for New York City at $10.00 a dose. And American Airlines says it is ready to fly the vaccine, free, to the United States.

There's only one catch: The FDA hasn't approved the plan. It first wants to inspect the factories in Germany and France and evaluate the vaccine, which is produced by pharmaceutical giants Aventis and GlaxoSmithKline, which already sell vaccine in the United States.

That's frustrating officials in the two states and New York City.

"The vaccine is exactly the same vaccine," says New York City health Commissioner Thomas Friedman. "It has the same three strains of flu to vaccinate against."

Other officials say the federal government has been trying to buy doses from the very same suppliers.

Adds New York Mayor Michael Bloomberg, who faces a $2 million bill for the vaccine, whether or not it is approved by the FDA: "Given the successful track record the vaccine has compiled, we're confident the FDA will grant its approval quickly."

‘FDA Needs to Act’

The FDA declined to be interviewed for this report, instead releasing a letter to Blagojevich which says, in part, "We have been working with foreign suppliers of flu vaccine to determine whether any excess supplies they have could be procured."

Says Blagojevich: "We can provide flu shots to our citizens now. All of this can happen, but the FDA needs to act and to act now."

Other federal officials deny the FDA is engaged in bureaucratic foot dragging.

"If they're careful and try to make sure that everything is safe and the way it should be, people say they're slowing it up," Fauci says. "But if something bad happens, then they say they were negligent."

So far, health officials expect this flu season to be moderate, like last year's. But even last year's moderate flu season killed an estimated 32,000 Americans.