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Pediatric Vaccine Stockpile at Risk

Makers Hesitate to Supply Government

By David Brown
Washington Post Staff Writer
Sunday, April 17, 2005; Page A01

Just three years after the largest and most serious shortage of childhood vaccines in two decades, the federal government's stockpile of childhood vaccines, designed as a buffer against shortages, is nearly empty -- and without immediate prospects of being filled.

Three of the four companies that produce the shots recommended for every American child told the federal government last year that they would not sell their products to this little-known but important piece of the nation's public health infrastructure.

Rita Lamb administers vaccine to Chandler Campbell, 5, at a health center in Las Cruces, N.M. The nation's stockpile of childhood vaccines is depleted. (Norm Dettlaff -- Las Cruces Sun-news Via AP)

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Although opinions differ, it appears that the Pediatric Vaccine Stockpile has become an innocent bystander wounded in the government's crackdown on deceptive accounting practices.

No one has accused the vaccine manufacturers of wrongdoing. However, they can no longer treat as revenue the money they get when they sell millions of doses of vaccine to the stockpile because the shots are not delivered until the government calls for them in emergencies. Instead, the vials are held in the manufacturers' warehouses, where they are considered unsold in the eyes of auditors, investors and Wall Street.

Today, the stockpile contains 13.2 million doses of vaccine, less than one-third of the goal of 41 million doses. It is supposed to hold supplies of eight shots that together protect against 11 childhood diseases. However, for two of those products -- including the workhorse DTaP, which protects against diphtheria, tetanus and pertussis -- it contains no doses. The vaccine is not in storage in company warehouses or anywhere else. It simply does not exist.

Created by Congress in 1983, the stockpile is supposed to contain enough vaccine to supply the nation's needs for six months. Its virtual collapse is an acute embarrassment to the Department of Health and Human Services, the Centers for Disease Control and Prevention, and the vaccine makers.

The stockpile has never reached its full target amounts, but its depleted state now means the nation could not easily weather another big vaccine shortage, potentially putting the health of millions of children at risk. Only two vaccines -- measles, mumps and rubella (MMR), and varicella (chickenpox) -- are warehoused in the desired amounts.

Memories are still fresh of 2001 and 2002, when the country did not have adequate supplies of five vaccines that together protect against eight diseases. That shortage did not lead to an increase in death or disease, but it did require physicians and clinics to ration and temporarily change the routine schedule of shots.

In testimony before Congress, Walter A. Orenstein, then head of CDC's National Immunization Program, called the situation "unique and unprecedented."

Last winter, the United States experienced a shortage of influenza vaccine. That product is not in the pediatric stockpile, but the near hysteria that erupted when contamination in a factory cut the supply of flu shots in half was further evidence of how vulnerable the nation is to the decisions and fortunes of the few remaining U.S. vaccine makers.

Although there have been informal discussions among the CDC, HHS, the Securities and Exchange Commission, vaccine companies and congressional staffers, there has been no concerted effort to find a solution that will persuade the companies to resume sales.

"If it was up to me, I'd start the meeting at 1 o'clock, lock the door, and wouldn't let anyone leave until they had found a solution," said Jerome O. Klein, a pediatrician at Boston University School of Medicine and a member of the National Vaccine Advisory Committee.

Klein's frustration is starting to be reflected in Congress.

"It's inexcusable that even though the administration had the money for this, they haven't made any progress," Rep. Henry A. Waxman (D-Calif.) said recently. "I don't care how they solve it -- they should just solve it."

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