Just three years after the largest and most serious shortage of childhood vaccines in two decades, the federal government's stockpile of childhood vaccines is nearly empty and without immediate prospects of replenishment.
Three companies -- Sanofi Pasteur (formerly Aventis Pasteur), Wyeth and GlaxoSmithKline -- told the federal government last year they would not sell their products, recommended for every American child, to this little-known but important piece of the nation's public health infrastructure.
Merck, the only other vaccine maker, agreed to contribute to the stockpile.
Although opinions differ, the Pediatric Vaccine Stockpile apparently has become an innocent victim of the government's crackdown on deceptive accounting practices.
No one has accused the vaccine manufacturers of wrongdoing; however, they no longer can treat as revenue the money they get when they sell millions of doses of vaccine into the stockpile because the shots are not delivered until the government calls for them during 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.
But the stockpile contains no doses for two of those products, including DTaP, which protects against diphtheria, tetanus and pertussis. The missing vaccine is not in storage in company warehouses or anywhere else. It simply does not exist.
Established 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 never has reached its target amounts, but the depleted state 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 and varicella (chicken pox) -- are warehoused in the desired amounts.
In testimony before Congress, Walter Orenstein, the head of CDC's National Immunization Program, called the situation "unique and unprecedented."
Despite informal discussions among the CDC, Department of Health and Human Services, the Securities and Exchange Commission, vaccine companies and congressional staffers, no concerted effort has been made to resolve the problem.
Rep. Henry Waxman, D-Calif. the ranking Democrat on the Government Reform Committee, said he was willing to sponsor legislation to carve out a legal exception that would allow companies to "recognize" revenue from sales to the vaccine stockpile -- if such a radical step becomes necessary.