Officials at the national Centers for Disease Control and Prevention say 4.5 million doses of flu vaccine went unsold as flu season winds down, despite nationwide shortages last fall that had worried seniors standing in queues to get shots.
U.S. health officials restricted the available vaccine to the elderly, very young children, the chronically ill and healthcare providers who deal directly with the sick from October until January.
CDC said more than 16 million healthy adults got flu shots, but only 43 percent of high-risk adults received vaccinations. Millions of healthy people decided to skip their annual flu shot to leave supplies for those who needed the vaccine most.
There were 18 flu-related pediatric deaths in 12 states -- California, Colorado, Georgia, Iowa, Maine, Massachusetts, Mississippi, New Jersey, New York, Ohio, Pennsylvania, and Vermont -- since January. More than 57 percent of children ages 6 months to 23 months were vaccinated.
After midwinter few people wanted the shot, and although for the most part it was a relatively mild flu season scattered outbreaks occurred.
A CDC spokeswoman told USA Today there are millions of leftover doses of vaccine every year but for vaccine to go unused during this flu season "gives one pause."
States are preparing to destroy more than 4 million unused doses of vaccine. Wisconsin received nearly 100,000 doses for children under 18 in low-income families but used only about half of them and has a surplus of nearly 50,000 doses worth about $365,000.
The state's Department of Health and Family Services had 44,000 leftover doses, and the Department of Corrections had enough unused vaccine for 4,000 flu shots.
State health officials asked the CDC to release vaccine to the general public in November but did not get federal approval to drop all restrictions until February. CDC sent out its 3.1 million-dose stockpile in late January hoping that vaccine would not go to waste.
"I think everyone who wanted it got it," Dan Hopfensperger, director of Wisconsin's immunization program, told the Milwaukee Journal Sentinel. "It's not a perfect science."
Half the expected U.S. vaccine supply, about 48 million doses, was lost when British health regulators found contamination at the Liverpool, England, plant of Chiron Corp. Chiron's manufacturing license to produce flu vaccine at the facility was restored by this month, but FDA inspectors must clear the plant and approve sale of the vaccine in the United States before it can be shipped this fall.
CDC would like to see about 63 million doses of vaccine available for the winter of 2005-06, compared with the 61 million doses that eventually were available this flu season.
There could be an oversupply if all vaccine producers come into the U.S. market. Sen. Evan Bayh, D-Ind., reintroduced legislation to ensure there is no repeat of last year's shortages.
The Flu Protection Act addresses the concerns of economic loss of domestic manufacturers by offering tax credits to encourage domestic production, guaranteeing U.S. government purchases of at least the recommended number of doses, and a buy-back program for leftover vaccine.
The marketplace is hit-and-miss for a vaccine formulated for different strains of virus each year that cannot be saved from one year to the next.
Pharmaceutical companies overproduced vaccine in 2001 and lost $120 million. Bayh's bill would cost about $800 million over five years to guarantee adequate supplies.
"The CDC should purchase flu vaccines in a way that will best prevent a future vaccine shortage and make the most of their funding dollars," Bayh said in late November. "By offering to purchase unused flu vaccines at the end of next year's flu season, the CDC will remove the economic disincentive currently facing manufacturers and encourage them to produce more vaccines in a fiscally responsible manner."
Researchers at the University of Michigan have proposed retrofitting existing pharmaceutical facilities to produce flu vaccine using cell cultures rather than the traditional method where virus is injected inside an incubated chicken egg, killed and extracted.
The egg-culture process takes at least four months to produce vaccine. Henry Wang, a UM professor of biomedical and chemical engineering, told the 229th meeting of the American Chemical Society that cell-culturing promises to produce vaccine in two months.
The CDC said influenza peaked in February with a dozen states and New York City reporting widespread outbreaks. Another 24 states reported regional outbreaks, and flu was scattered in New Hampshire, Puerto Rico and the District of Columbia.
The World Health Organization and epidemiologists warned of a possible pandemic of far more deadly avian flu after outbreaks of bird flu killed at least 45 people in Asia. The flu strain known as H5N1 has affected poultry in eight Asian countries. The FDA has authorized clinical trials of 8,000 doses of an experimental bird flu vaccine.
Bayh's bill would fund research to improve preparedness for a pandemic.
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