Fluke flu year highlights pitfalls of vaccine distribution system

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By Elizabeth Cohen
CNN Medical Correspondent

(CNN) -- Deborah Jones, the infectious disease nurse at a nursing home in Stockbridge, Michigan, is worried. None of her patients has received flu shots, and the flu season's coming. Every year, influenza kills tens of thousands of people, most of them old and frail, just like her residents.

She isn't just worried -- she's angry. "I'm frustrated that I don't have any vaccine and my aides come in and say they got a flu shot at their doctor's office or a supermarket has a sign up that says, 'Flu shots for $10.'"

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So why are young, healthy people getting flu shots, while Jones's residents -- those at the highest risk of being hospitalized or dying -- have to wait?

Flu experts say the answer's very simple: vaccination distribution is a private endeavor. The federal government makes sure that vaccines are safe and effective, but doesn't have much involvement in distribution.

"Vaccine production in this country is not tied to public health priorities," said Dr. William Schaffner, chair of the department of medicine at Vanderbilt University School of Medicine, and a liaison member of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Schaffner says this year, because of a delay in getting flu vaccine to the public, the CDC grappled with the question of whether the federal government should try to get vaccine from the hands of healthy people to those who need it most -- the elderly and those with chronic medical conditions.

"The committee decided there was no way to drive that bus," Schaffner said. "There's no organized way to do it. We don't have the influenza police."

Other experts agree. "I would love for the people who need it most to get it," said Dr. Pierce Gardner, an infectious disease specialist at the State University of New York at Stony Brook. "Is there a viable system to control that? No."

Does it matter that Deborah Jones's nursing home residents haven't been inoculated yet? It all depends.

In a typical season about 75 million flu shots are given out, mostly in October and early November. Once given, it takes about two weeks to build up antibodies to the virus, plenty of time to protect people before flu season hits, sometime between December to March.

But this year has been anything but normal. Manufacturers had a hard time making flu vaccine -- instead of shipping it out in August and September, they shipped 28 percent in October and plan to ship 42 percent in November and another 30 percent in December. This means that, according to the CDC, vaccinations will still be occurring in January. Will that be early enough?

"You don't have to be a rocket scientist to figure out it all depends on when flu arrives," said Dr. Arnold Monto, professor of epidemiology at the University of Michigan School of Public Health. "If it arrives early we may have a problem. If it doesn't, we don't."

Early would mean around the second of third week of December, he said. According to the CDC, only four out of the past 18 seasons have been early. In the other 14, flu activity peaked somewhere between January and March.

Monto and other flu experts agree that if the flu season arrives early more people would die and become severely ill.

If there's an early season, "we're likely to have in spot parts of the country increased morbidity and mortality, and that's what we're all fretting about," said Schaffner. "But it's relatively reassuring that it wasn't a bad October for the flu. If there were lots of influenza around lots of parts of the country in October, we'd be much, much more worried."

According to the CDC, 12 states reported "sporadic" flu activity for the week ending October 21, while the rest of the country reported no activity. "Sporadic" is the lowest level of activity.

Most flu experts -- including those at the CDC -- agree that it's impossible to predict flu seasons with any accuracy. However, many are breathing a preliminary sigh of relief at what they say was a mild October because a bad October can be an indication of an early season.

Flu experts say in some ways there really aren't lessons to be learned from this year's situation because of the unique reasons for the delay. It happened because one of the three strains in the flu shot was a slow-grower, which meant the entire production process took longer. Secondly, the Food and Drug Administration, because of safety problems, shut down vaccine production at Parkedale Pharmaceuticals, one of four companies that make vaccine. The FDA then cited another company, Wyeth-Ayerst Laboratories, with manufacturing violations, which delayed its production for several months.

Wyeth-Ayerst and the other two companies that make vaccine, Medeva Pharmaceuticals, Inc. and Aventis-Pasteur, plan to make a total of about 75 million doses, approximately the same number used last year. But the delay in getting them to the public has led to spotty supplies. While Deborah Jones is still waiting for vaccine in Michigan, other nursing homes inoculated their residents weeks ago. Some supermarkets and drug stores have flu shots, but Eckerd drug stores can't get enough -- the chain has cancelled its vaccine program.

The Centers for Disease Control is trying to help by purchasing 9 million doses of flu vaccine from Aventis-Pasteur, which the CDC plans to distribute to high-risk clinics. Aventis said it will ship those doses in December.

And that small shift from private to public control of vaccine points to one lesson for the future, according to Dr. Kathleen Neuzil, assistant professor of medicine at the University of Washington School of Medicine.

"I think there will be a push in the future years to have more vaccine go through health departments and public areas so it can be triaged," she said.

As for this year, flu experts say, all we can do is cross our fingers and hope that a mild October really does mean we won't have an early flu season.

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October 25, 2000

CDC Flu Vaccine Update
National Institutes of Health

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