FORT LAUDERDALE, Fla.

six-year history of flu shots in America: 1998, a shortage. 1999, a glut. 2000 and 2001, temporary but acute shortages. 2002, a glut with 12 million unused shots.

And this year, a near-complete sellout by mid-December amid an early and widespread outbreak of a new strain of flu that may not fully hit the East for weeks.

The erratic and unpredictable nature of the influenza virus, of vaccine production and of our demand for shots has led immunization experts to call for big changes in the way the government and manufacturers handle our best weapon against flu.

Some specialists want the government to encourage companies to make more vaccine, by buying and stockpiling millions of extra doses every year or guaranteeing their sale, even at the risk that millions of tax dollars worth of vaccine would be wasted.

Others suggest the government stabilize the demand by more aggressively urging people to get an annual flu vaccination, perhaps making it mandatory for admission into school.

Officials at the U.S. Centers for Disease Control and Prevention say they will try to accelerate new scientific methods that would speed up production of the vaccine.

While there are disagreements over all those approaches, officials hope this year’s vaccine shortage can force action on all fronts.

“We have to do something,” said Dr. John F. Modlin, a pediatrics professor at Dartmouth Medical School who until October chaired the federal Advisory Committee on Immunization Practices. “We should take advantage of the scare and recognize that in past years, we have not done a real good job at getting flu vaccine to those who should get it.”

One who should get it is Sy Schulman, a retired IBM manager from Boca Raton, Fla. He never had a flu shot in fear it would make him sick, but this year he changed his mind after hearing about flu deaths out West and seeing friends get ill. He tried his doctor, the Palm Beach County Health Department and hospitals. Nothing. Flu shot programs at retail stores ended in November.

“I want to get a shot. I can’t find one. I’m not alone,” Schulman said. “The way it’s being handled now is not working.”

For most healthy adults and children, catching a flu virus is a mere annoyance. The virus typically infects 10 to 20 percent of the population every year but causes only a few days of fever, sneezing and aches.

But flu kills an average of 36,000 Americans and hospitalizes 114,000 each year among the most vulnerable groups, namely the elderly, infants and people with chronic disease or immune problems.

The toll could be twice as large from this year’s outbreak of Fujian A flu, a strain that was recognized as a U.S. threat too late to include in this year’s vaccine formula.

The nation has used up almost all of 87 million doses of vaccine made this year. Experts blame the unpredictable boom-and-bust pattern of flu and the vaccine supply.

In 1998, vaccine supplies were tight after a manufacturer dropped out of the market. The next year, flu was mild, demand fell and shots went begging. In 2000 and 2001, quality problems and slow-growing virus cultures at the four factories delayed supplies for months and created sharp shortages.

Last year, 95 million doses were made anticipating heavy demand after the CDC urged everyone age 50 to 65 to get shots. But the flu was mild, demand was slow and 12 million doses went to waste.

Stung by the losses, the two remaining manufacturers this year produced 83 million shots and another made 4 million doses of a new nasal spray vaccine, FluMist. The unexpected surge in demand because of the outbreak depletes the cupboard, and it’s too late to make more.

Several vaccine experts and federal officials said no one should expect the companies – Aventis-Pasteur and Chiron Corp. – to have made another big batch this year and risk losing big dollars. Vaccine profits are slim under best conditions.

“I don’t fault the manufacturers at all,” Modlin said.

He and others said it’s up to the government to shoulder the risk and be responsible for ensuring strong vaccine supplies. The CDC should either buy a big stockpile in case of an outbreak or guarantee it would pay for unsold vaccine, so factories make at least 100 million doses, these experts said.

“You can’t cut it as close as we did,” said Dr. Carol J. Baker of Houston, a member of an American Academy of Pediatrics committee on infectious diseases and vaccines. “This year is an example of how it can happen. We need to have a stockpile of vaccine.”

The National Vaccine Advisory Committee in a study issued last week said federal vaccine subsidies or tax breaks could have induced the companies to make tens of millions more shots this year, to cover all who needed them.

Subsidies are not a simple answer, federal officials said. At a wholesale price of $8 a shot, buying 10 million too many doses that get tossed in spring would waste $80 million. The CDC is trying to come up with a reasonable plan.

“You don’t just want to say you’re going to be a blank check,” said Tommy Thompson, secretary of Health and Human Services, which oversees the CDC.

Buying more vaccines, even if some are wasted, would be money well spent, said Frank Sloan, professor of health policy and economics at Duke University who chaired a vaccine financing study by the Institute of Medicine.

Just as a seafood restaurant that wants to insure it has enough fish throws out some at the end of the night, Sloan said the government should accept that it will throw out vaccine each year.

“Would you argue the fire department is a waste? You didn’t have a fire today,” Sloan said. “It’s like insurance.”

The government could make health insurers bear some of the risk of losses, Modlin said.

Some experts said the nation could minimize excess doses by persuading more people to be vaccinated among the 185 million who should get shots. In 2001, only 65 percent of seniors nationally got flu shots. If a higher percentage were vaccinated, it would be easier to figure out how many to make.

The CDC in recent years extended its list of people recommended for shots, to those ages 50 to 64 and ages 6 to 23 months. Next year, the CDC will include all children through age 18.

Many think that eventually, health officials will recommend flu vaccine for everyone, to reduce the spread of the virus from the healthy to the vulnerable.

Barbara Loe Fisher, president of the consumer group National Vaccine Information Center and a former member of the federal vaccine board, said she can envision employers requiring flu shots at work.

Some day, schools could add flu to the list of mandatory vaccinations children need for admission. People ages 5 to 20 are the most likely to get the flu, Modlin said, although they generally have mild cases, despite this year’s 42 flu fatalities in children.

Fisher said it would be a mistake to force people to be vaccinated, because of the tiny but real risk of allergic reaction and side effects.

Some experts hope that Wyeth Pharmaceuticals can perfect its nasal spray FluMist so it no longer risks respiratory infections among the elderly and children. It’s now allowed only for healthy people between 5 and 50. If everyone could use it, more people would get vaccinated.

Another way to bolster the vaccine supply is to speed up the six-month process of growing the virus for vaccine, so backup supplies could be made quickly during outbreaks.

Every February, international health officials predict which of the many flu virus strains will be most prevalent in the fall. Two A strains and one B strain are then chosen in March to make up the U.S. vaccine. Manufacturers plant small virus samples in tens of millions of fertilized chicken eggs to grow the vaccine.

The process has pitfalls. The virus may not grow well enough in the eggs. Health officials may guess wrong about which strains will be prevalent, as with Fujian this year.

The vaccine advisory board knew Fujian would be around, Fisher said, but feared it would grow slowly and delay vaccine production. The government instead chose the closely related Panama A strain, which had been around last year.

Secretary Thompson said the HHS will use a piece of an extra $50 million flu allocation from Congress to speed up research on a faster and more reliable method of growing viruses, using kidney cells from green monkeys instead of eggs. He hopes for an additional $100 million next year.

The monkey cell method has not yet been proven safe and likely would not be ready for federal approval until 2007. Another new DNA technology in the works, reverse genetics, more quickly creates virus samples to be planted in the eggs or monkey cells.

Fisher warned that extensive tests must be done to make sure the new methods do not spark dangerous allergic reactions.

“You really need to know what you are doing,” Fisher said. “To get a supply out there quickly, you need to be sure you are not contaminating the vaccine.”


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