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Shortfall spurring flu-shot changes

Could this be the last flu-shot shortage?

The severity and suddenness of the current vaccine shortage seems to have created a strong will in federal health officials to ensure it never happens again, Utah health experts say.

Although vaccine shortages and delays have been common in past years, losing half the supply literally overnight is forcing health-care providers this year to restrict shots to only those who are most susceptible to flu complications.

Since regulators closed down Chiron, one of two vaccine manufacturers, myriad problems are being reported around the country, from excessively long lines to price gouging.

Public health and federal officials are now bandying about several ideas for dealing with flu vaccine manufacture and distribution issues to avoid a repeat of this year's crunch, state Department of Health administrators said.

The first step is increasing the number of manufacturers willing to produce the vaccine.

"The problem simplistically is there's not enough of a profit margin to induce" a drug manufacturer to take on the job, said Dr. Robert Rolfs, department epidemiologist. "There's a fairly high risk because of liability, also, so only two manufacturers were making it for the (United States)."

Aventis Pasteur and Chiron were to split the task of providing the needed vaccines.

The limited number of manufacturers was the core of the problem with previous shortages as well. If something went wrong, there was no one to pick up the slack. When one company had problems getting cultures to grow a couple of years ago, there was a shortage, though nowhere near as severe as this one. If one of the companies had some type of production problem, there were delays.

This year, first came word that some of the vaccine being made by Chiron in England had been contaminated and would not be distributed, followed within days by word that the Chiron facility was being forcibly shut down, its share of the vaccine permanently unavailable. The supply had been effectively cut in half.

Even the full 80-plus million doses the two companies were supposed to produce this year would not have vaccinated everyone who should have it, Rolfs said.

"Discussions have included things like trying to stimulate the market and recommending wider use of the vaccine than we even have now," he said. "The more profitable the market, the easier to pull companies into it. And there's quite good evidence that we should vaccinate far more people than we now recommend it for. If 200 million were vaccinated, it's more likely for companies to come into the market."

Another possibility is for the government to purchase a fixed amount of vaccine so that at least part of the demand is guaranteed. Last year, the flu season came early and hit hard, and an extraordinarily large number of people got vaccinated. In other years, the numbers have sometimes lagged considerably. Guaranteeing a certain amount of vaccine would be purchased might ease fears of potential manufacturers who might be jittery about the possibilities of losing money, Rolfs said.

Talk also centers on changing the way the vaccine itself is produced, allowing manufacturers to produce the vaccine in cell cultures, rather than in eggs, as is currently done. Using cell cultures is "supposedly more robust and could rapidly produce at capacity," Rolfs said.

Not only that, but it takes millions of eggs to produce vaccine for influenza as it's now produced. And that takes both time and a lot of chickens.

Officials shot down suggestions that some of the doses could be imported from Canada, saying it did not have Food and Drug Administration approval, something required for any prescribed treatment.

Regardless of what officials do to prevent further shortages, most people will not be able to get a flu shot this season, experts say. But they can minimize the impact somewhat.

"The most important thing is, if you're healthy, defer (your own dose) and be an advocate for a family member who falls into a high-risk category," said Linda Abel, the department's immunization program director. "Be an advocate and help those who need it find a source."

Utah is one of eight states that now has sporadic flu activity, according to the Centers for Disease Control and Prevention.

Each year people in identified high-risk groups — the elderly, children 6 to 23 months, pregnant women, those with certain chronic medical conditions, children on aspirin therapy, health-care providers who do direct patient care with high-risk populations — are told to get a flu shot. This year is different, however, in that close family members are not being allowed to get them simply because someone in the household fits one of the categories.

People can also reduce the risk of influenza in other ways, Abel said. She tells people to stay home if they're sick. That means no trip to the grocery store, the school, church, work, wherever. And she stresses the need to wash your hands frequently and thoroughly "whether or not you're sick." She suggests having hand sanitizer available and using it.

Avoiding shortages

Utah health experts says keys to preventing flu vaccine shortages include:

Increasing the number of vaccine manufacturers.

Increasing the number of doses to improve manufacturers' profits.

Having the government purchase a fixed amount of vaccine to guarantee demand.

Changing the way vaccine is produced so more can be made quickly.