Now there's a surplus of flu vaccine


April 08, 2005|By Erika Niedowski | Erika Niedowski,SUN STAFF

When the Centers for Disease Control and Prevention learned last fall that the nation's flu vaccine supply had unexpectedly been slashed in half, health officials responded quickly with a voluntary rationing plan.

Turns out the plan worked a little too well.

More than 3.5 million doses went unsold during the 2004-2005 influenza season, and another 1.2 million "emergency" doses purchased by the federal government in December were not used and will have to be thrown away.

"It's almost impossible to use up all of the doses by the end of the season because distribution is not something that's able to be perfectly coordinated," said Dr. Lance Rodewald, director of immunization services at the National Immunization Program, which is part of CDC.

"The outcome of the season and the degree to which it was a success had to do with how well we were able to reach the priority groups," he said.

There was both good and bad news on that front. Some 17 million healthy individuals - asked to forgo immunization to leave vaccine for those who needed it most - did just that. But many people in the "at-risk" categories never got flu shots either.

According to CDC statistics released this week, just over a quarter of adults with chronic illnesses had been vaccinated by the end of January, down from 34 percent the year before. Vaccine coverage among health care workers and those 65 and older dropped by 4 and 3 percentage points, respectively, to 36 percent and 63 percent.

Despite the unprecedented shortage - which led to long lines at flu clinics and left many vaccine-seekers exasperated - some states now find themselves destroying tens of thousands of unused vials. In Wisconsin, health officials have more than 44,000 leftover doses; in Arkansas, some 10,000 may be thrown away.

Greg Reed, program manager for the Maryland Center for Immunization, said the state's public health departments likewise have some remaining vaccine, but he doesn't yet know how much. "Maryland was doing very well in terms of vaccinating persons who were in the high-risk categories," he said.

Nationwide, preparations for the 2005-2006 season have been under way for months. But it's unclear how many doses will ultimately be available. Although demand varies, as many as 87 million Americans have received flu shots in a single season.

Rodewald said Sanofi Pasteur (formerly Aventis Pasteur), which provided the bulk of last season's vaccine, expects to make 50 million to 60 million doses this year, while MedImmune will likely make 3 million doses of its FluMist nasal vaccine. That vaccine, however, is approved only for healthy people between 5 and 49.

At least one other manufacturer could be licensed to sell vaccine in time for the fall, Rodewald said.

The wild card is California-based Chiron Corp., which triggered the crisis in October after its manufacturing license was suspended by British officials because of contamination at its Liverpool plant. That resulted in the loss of nearly 50 million doses bound for the U.S. market.

Though the company's license was restored last month, CDC officials say they aren't counting on Chiron doses. Before the vaccine can be sold here, Food and Drug Administration regulators must inspect the company's overseas plant to ensure its vaccine is safe.

A Chiron spokeswoman, Alison Marquiss, said the company has begun the vaccine production process but would not say how many doses it hopes to provide.

Looking ahead, CDC's Rodewald said public health officials are planning for three scenarios. The best case has Sanofi, Chiron and perhaps a third manufacturer providing vaccine. In the "base" case, Sanofi would be the lone major provider. In the worst case, Sanofi would suffer a massive production failure, prompting a shortage even greater than last season's.

To prepare for the worst, CDC not only will have a flu vaccine stockpile, as it did last year, but will order bulk amounts of "monovalent," or single strain, vaccines. The ready-to-inject doses that patients get contain a mixture of three strains, one of which usually changes every year. Should the country run short, manufacturers could try to quickly mix the monovalent stocks.

"We're trying to learn a lesson to have two insurance policies now," Rodewald said. "Every year we learn something new and how to improve the situation a little bit."

Last season, Mother Nature cooperated - delivering a moderate flu season that kept the shortage from turning into a public health crisis. Unfortunately, said Rodewald, "That doesn't tell us anything [about] what it's going to be like next year."

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