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Flu vaccine shortage a worldwide crisis

Experts warn situation ripe for pandemic

By Michael Coren

In October, Chiron Corp. said it was unable to deliver about 50 million doses of the flu vaccine to the United States.
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Centers for Disease Control & Prevention
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(CNN) -- Concerned about the flu vaccine shortage at home, U.S. public health officials are examining the defenses against a global flu outbreak -- and they don't like what they see.

"We're very unprepared," said Ira Longini, a professor at Emory University's Rollins School of Public Health. "We haven't made influenza a high priority in this country, or anywhere else that I know of."

The World Health Organization, based in Geneva, Switzerland, recently warned that a global flu outbreak will happen in a matter of time and urged nations to strengthen their health infrastructures before it hits.

The WHO called a summit in November of major flu vaccine manufacturers and international health officials, warning them flu vaccine production capacity could be overwhelmed by the possible pandemic on the horizon.

According to a written report from the meeting, "participants agreed that should a pandemic virus emerge now, no manufacturer would be able to move immediately into commercial production." The earliest production of a vaccine could begin is in the summer of 2005, the report said.

Officials attempting to prevent flu outbreaks face a formidable task.

Each spring, a global network of scientists and influenza centers, working through the United Nations-sponsored WHO, decide which three influenza strains of those circulating will be included in the vaccine. In the fall, when flu season hits North America, Americans find out if the scientists picked the right ones.

Because flu viruses mutate so rapidly, no two flu seasons are ever the same.

Another pandemic?

Flu pandemics begin when major changes to the virus occur spontaneously -- a merge between animal and human influenza viruses, for example -- and infects humans with no resistance to the new strain, according to the WHO.

Since 1900, about three pandemics have broken out, occurring in about 20- to 30-year intervals.

The Spanish flu of 1918-1919 killed more than 20 million people worldwide, with some estimates putting the number of deaths at more than 40 million. It was followed by less deadly outbreaks in 1957 and 1968, according to the Centers for Disease Control and Prevention in Atlanta, Georgia.

That makes it nearly 37 years since the last major outbreak in the United States. "It makes us very concerned that we are at risk for another pandemic in the very near future," said Dr. Mitchell Cohen, director of the Coordinating Center for Infectious Disease at the CDC.

"[Viruses] are very unpredictable. A disease that emerges in one place can be on the other side of the world in 24 hours," Cohen said.

CDC models predict the next pandemic will kill between 2 million to 7 million people worldwide, according to the WHO. Developing countries are expected to suffer the most, but industrialized nations could be seriously affected by up to 233 million doctor visits and 5 million hospitalizations from influenza.

U.S. health officials said it could also overwhelm the U.S. health care system, which annually records about 200,000 hospitalizations and 36,000 deaths from flu complications, according to the CDC.

Shortage not a new problem

The recent flu vaccine shortage in the United States is not the first.

"The problem with vaccines is not a new problem," says Cohen. "For the last decade, we have had reduction in the number of vaccine manufacturers. ...The issue comes down primarily to economics ... Profit margins are small."

The cost and uncertainty of making flu vaccines, which can leave companies with millions of dollars in unusable product, have steadily eroded the number of vaccine makers in the world.

Because flu viruses mutate so rapidly, each batch of vaccine can be used during only a single flu season. Any remaining vaccine must be destroyed, sometimes sending millions of doses -- some costing as much as $10 each -- into the incinerator.

start quoteThe existing flu vaccine manufacturing system is not adequate to meet the nation's needs in the event of a flu pandemic or a shortage.end quote
-- Health and Human Services Secretary Tommy Thompson

Adding to costs are manufacturing techniques that have not changed much in 50 years. To produce the flu vaccine, a live virus must be injected into millions of bird eggs, usually chickens', so it can replicate. It is then extracted, killed and used in the injectable doses.

The inability to manufacture these vaccines quickly and cheaply is one of the biggest challenges.

"We have no real capacity to make [a pandemic] vaccine right now," said Longini, who studies the spread of global flu epidemics.

The United States relies on only three licensed companies to supply its 100 million or so doses of flu vaccine each year, the CDC reports. Only two of them -- Chiron Corp. and Aventis Pasteur -- produce injectable vaccines for the United States.

In October, Chiron Corp. announced it was unable to deliver about 50 million doses of the flu vaccine to the United States after British authorities closed its manufacturing plant because of bacterial contamination. Almost overnight, about half of the U.S. flu vaccine supply dried up.

Public health officials were forced to slash the number of Americans eligible to get flu shots in half, from about 185 million last year to an estimated 90 million this season.

The next step

The U.S. Department of Health and Human Services said it is taking steps to make sure that the flu vaccine shortages -- and the economics of manufacturing them -- are a thing of the past.

"The existing flu vaccine manufacturing system is not adequate to meet the nation's needs in the event of a flu pandemic or a shortage," said Health and Human Services Secretary Tommy Thompson in a statement.

The department issued a press release in October saying it will request $100 million to fund cell research for mass production of vaccines next year.

So far, the research to develop alternative vaccine methods is promising. Tissue cells, tailor-made to produce viruses, are already being grown as biological factories to be harvested for flu vaccines. If successful, the new biotechnology may provide the answer to chronic vaccine shortages.

"It's technically possible and it is being done in labs," Longini said. "The next step would be for drug manufacturers to make that technology workable on a mass level and guarantee the quality of product."

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