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Officials: Skip flu shot if healthy

A vaccine shortage leads to a call for rationing so high risk people, many of whom are in Florida, can get shots.

By LISA GREENE, Times Staff Writer
Published October 6, 2004

In a stunning turnabout, healthy Americans this year will be asked to forego flu shots after British authorities Tuesday shut down the plant that provides almost half of America's flu vaccine.

Federal officials said priority should be given to high-risk groups such as the elderly, people with chronic health problems and children between the ages of 6 and 23 months.

"This is disappointing news that creates a serious challenge to our vaccine supply," said Tommy Thompson, secretary of the U.S. Department of Health and Human Services.

While some health officials said the news raises the possibility of more sickness and death from the flu this year, others said it is too soon to know how bad the flu season will be.

"We have to take a deep breath and put things in perspective," said Dr. Julie Gerberding, director of the Centers for Disease Control, who insisted that no public health emergency exists. "We don't want people to rush out and look for flu vaccine. We're going to do all we can to enhance the supply and try to come up with more."

Nonetheless, news of the closing of Chiron Corp. was a shocking development in the fight against a major public health threat. Influenza kills about 36,000 Americans and hospitalizes 114,000 more each year. Government officials have spent years begging more Americans to roll up their sleeves and get flu shots.

Now, they're asking them to hold off.

Health officials had not determined Tuesday how to redistribute vaccine, whether more shots can be made or how to enforce the call for healthy people to delay getting shots.

The shortage could hit Florida especially hard.

Chiron Corp. was the supplier for most of the state health department's 300,000 doses of adult flu vaccine. The department supplies some 10 to 20 percent of the state's flu shots.

Chiron's license to make flu shots at its plant in Liverpool, England, was suspended by British regulatory officials. The company said Tuesday it will not deliver any shots this year.

Chiron was expected to provide 46-million to 48-million doses of the planned 100-million doses of U.S. flu vaccine. The company's supply already had been delayed because of concerns about contamination in several million doses.

U.S. officials said they still are unsure of how severe the problem is and said they are working with British regulators to learn more.

In Florida, some flu shots already have been delivered to doctors' offices, pharmacies and even grocery stores. Some offices already have scheduled their annual flu shots for employees.

But Dr. John O. Agwunobi, secretary of the Florida Department of Health, urged officials Tuesday to provide shots only to those in high-risk groups, at least for now.

"We are urging individuals who are well and healthy to make sure Florida's vulnerable are cared for first," he said.

Pediatric flu shots are less affected by Tuesday's news, since they are made by Aventis Pasteur, the other flu shot manufacturer.

The news caught hospitals and doctors' offices off-guard Tuesday.

Some don't have flu shots yet and aren't sure where to get them. St. Petersburg's Bayfront Medical Center, for example, ordered all but 500 of its 10,000 flu shots from Chiron.

Tuesday's events underscore criticisms that infectious disease scientists have long had about the way flu vaccine is supplied - from antiquated technology used to produce the vaccine, to a system that places the entire supply of shots in the hands of two private companies.

"There's been concern for several years about the lack of people producing vaccine," said University of South Florida professor John Sinnott, director of the Florida Infectious Disease Institute. "Here we see there's no backup plan when somebody who makes half the vaccine is shut down. . . . The lack of planning at a federal level is a concern."

Sinnott said the shortage is likely to cause more flu deaths this year.

"We can hope that one, it's a mild winter, two, that no epidemic strains (of flu) appear, and that three, we find some more vaccine," Sinnott said. "But those are three big "ifs.' "

Thompson, the federal Health and Human Services secretary, said at a news conference Tuesday that a new vaccine technology needs to be developed. He called on Congress to fund his $100-million request in next year's budget to work on new technologies.

Research efforts received half that this year.

"It would be much easier for us to deal with shortages and unexpected problems," he said. "We need to make this important shift in how we produce flu vaccine."

Agwunobi said Florida residents should remember that no flu cases have been reported in the state this season.

"I'm going to do my darnedest" to ensure flu shots go only to those who need them most, he said.

But whether the state has the authority, or intention, to sanction doctors or pharmacists who give out shots to the general population was unclear Tuesday.

"At a minimum, we're going to issue strong advisories to the private sector, urging them to only offer vaccine to high-risk groups," he said.

He also said it's possible the state could put out rules to prevent price-gouging for flu shots.

Q&A: FLU SHOTS

Q. Why is there a shortage?

A. Only two companies - Chiron Corp. and Aventis Pasteur - were making flu shots for the United States this year. In the past, as many as four to six companies did. Chiron's vaccine was being made in a factory in England, and British officials on Tuesday revoked the company's license over concerns about manufacturing standards at the plant.

Q. Can't Aventis or some other company just make more?

A. No. Vaccine production takes several months at best, starting with growing the vaccine strain of the virus in chicken eggs and ending with vials of vaccine that must pass an array of federal safety tests before the vaccine can be released for use. Aventis reports that it's already operating at full capacity and can't make more until after November, once existing orders have been filled.

Q. What about diluting the vaccine to get more shots from each dose?

A. Officials are discussing that, but it isn't known yet if that would be safe or effective.

Q. How about that inhaled flu vaccine? Will it be available and is it safe?

A. About 1.1-million doses of MedImmune Inc.'s FluMist will be available for healthy 5- to 49-year-olds and even health care workers. It's made from live but weakened influenza virus, and experts say it is not necessary for anyone who gets it to be quarantined for a week to keep from spreading it to others.

Q. Why can't the government give vaccine to those who need it most?

A. Experts say the government doesn't have that authority, because vaccine has already been sold to private groups that run flu shot clinics. Trying to seize vaccine likely would spark lawsuits that could delay anyone getting vaccine in time for the flu season.

Q. What about cities or states that bought vaccine only or mostly from Chiron?

A. Federal officials are working with Aventis to spread remaining shipments to parts of the country that need them most.

Q. How bad will the shortage be?

A. Between 90-million and 120-million Americans are at high risk of complications from the flu or have close contact with people who are, but not that many get shots. Last year, more than 80-million people got shots. Typically, 50-million to 80-million do each year.

Q. What can I do if I can't get vaccine?

A. Discuss with a doctor getting a prescription for one of the antiviral drugs that can lessen the severity of flu if taken right after symptoms begin.

- Associated Press

[Last modified October 6, 2004, 01:23:15]


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