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Flu vaccine shortfall generates confusion

The announcement that the nation's supply will be cut in half has flu shot providers trying to sort out new strategies.

By LISA GREENE, Times Staff Writer
Published October 7, 2004

When Publix stores offer flu shots this fall, any customer can get one. But at Walgreens, only high-risk patients can. And at CVS, nobody can get a shot - at least for now.

Uncertainty and confusion reigned Wednesday as doctors, health officials and private flu shot providers scrambled to find new sources for shots after the U.S. vaccine supply was unexpectedly cut in half.

The loss was a "catastrophe," said the U.S. surgeon general, Richard Carmona, who was in Tallahassee on Wednesday.

The shortage only highlighted what flu experts have long said with less fanfare: The system for producing vaccines in the United States is woefully in need of an overhaul.

Not enough companies make vaccine, there's little control over how it's used, and the technology for making it is outdated.

The result is that a key protection from one of the country's biggest killers can be threatened by something as simple as one factory being labeled unsafe. That's what happened Tuesday when British officials shut down the Liverpool, England, plant of vaccine maker Chiron Corp.

"Our entire vaccine production system is fragile in this country," said Dr. Julie Gerberding, director of the federal Centers for Disease Control and Prevention. "The bottom line is we need a comprehensive national strategy with government and the private sector to develop manufacturing capabilities that simply don't exist right now."

With up to 48-million doses of flu vaccine now unavailable, the CDC on Wednesday was trying to map out areas that have vaccine and those likely to need it most. Locally, providers of flu shots, from doctors to drugstores, were sorting out how to prioritize vaccines, if they had any to offer at all.

"We're all in the same big hole right now," said Dr. Randy Shuck of St. Petersburg. "I'm just hoping we don't have a bad flu season."

Shuck made his regular visit Wednesday to a housing complex to care for elderly shut-ins. Ordinarily, he would have been giving flu shots to those patients. Instead, he was fuming after his office called local pharmacies and heard they were giving shots to anyone who asked. The CDC has asked that healthy people forgo the shots, saving them for people more likely to due from flu, such as the elderly or those with chronic illness.

"If there is no legislation to monitor these things, perhaps that's what we should look at," he said. "Is it okay to give outside doctors' offices, if they're not going to follow the rules required of us?"

Each year, the flu kills 36,000 Americans and hospitalizes about 114,000 more.

National flu experts stressed the need for broad changes. The problem: Making the vaccine is expensive, but not profitable. The shots don't sell for much, people get them once a year, and unused shots have to be thrown away each season.

"A lot of people want the vaccines," said Dr. Walter Orenstein, associate director of the Emory Vaccine Center and former director of the CDC's immunization program. "They just want somebody else to pay for them."

Similar problems affect other vaccines, not just flu, Orenstein said. In the past four years, there have been vaccine shortages for nine different diseases, from flu to measles.

Scientists say the government needs to consider several options, from setting up financial incentives for companies to start making vaccines to guaranteeing a buyback of unused vaccine.

"We have to do something pro-active to ensure a stable influenza vaccine supply," said Dr. Greg Poland, a professor at the Mayo Clinic College of Medicine and a member of the CDC's advisory committee on vaccines. "This is an issue of the health of the nation. . . . We've got to get it right."

Some say the government needs to get into the vaccine-making business, although others say that might not solve the problem.

"Having the government involved doesn't necessarily mean we won't have problems," Carmona said. "This contamination was something that could have happened even if it was a government organization that was doing it."

The other company making flu vaccine this year, Aventis Pasteur, now expects to ship 55.4-million doses. But its ability to produce more to fill in for the lost Chiron vaccine is limited.

Flu vaccine is grown in eggs and takes months to make. That means scientists must decide several months beforehand what type of flu is likely to be most prevalent the next season. It also means that if there is a sudden shift in the strain of flu, any existing vaccine wouldn't be effective, and making new vaccine would take too long.

That's a key reason why many flu experts fear another global flu pandemic, such as the 1918 epidemic that killed more than 20-million people.

U.S. Health and Human Services Secretary Tommy Thompson called this week for Congress to fund his $100-million request to develop technology to grow flu vaccine in cell cultures instead of eggs. Such a change would be a huge step forward, Poland said.

It would mean growing virus for vaccine inside cells; anything from human cells to monkey kidney cells are possibilities. The cells would be easier to keep sterile and would cut vaccine production time at least in half, he said. Those changes could make the supply more stable and make it possible to respond to sudden shifts.

But for too long, Poland said, the vaccine problem hasn't registered with the public.

"We just take it for granted. They're so cheap we don't even think about it," he said. "It's an issue we have as a society and as the science profession. We have difficulty investing the necessary dollars in prevention, as opposed to reaction."

As for this year, people who want flu shots may have to look much harder for them. Local health departments have few, if any, doses. Some hospitals and doctors' offices also lack shots. At Walgreens, customers must answer a questionnaire and will get a shot only if they're in a high-risk group.

But at Publix, any customer can get one. Spokeswoman Maria Rodamis said the grocery chain plans to follow any mandatory restrictions on the shots, but to set other limits would be unfair to customers.

"To do so beforehand might cause the very thing we're trying to avoid, hysteria," she said.

Gerberding of the CDC resorted Wednesday to advising people to use common sense. Wash your hands, cover your nose and mouth when you sneeze or cough, and stay home when you're sick, she said.

Times staff writer Steve Bousquet contributed to this report.

[Last modified October 7, 2004, 00:30:24]

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