WASHINGTON – 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 future 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 they would not sell their products for this little-known but important piece of the nation’s public health infrastructure.
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 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 officially 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 missing 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 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 (MMR), and varicella (chicken pox) – 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, the head of CDC’s National Immunization Program, Walter Orenstein, called the situation “unique and unprecedented.”
Last winter, the United States experienced a shortage of influenza vaccine. Although that product is not in the pediatric stockpile, the alarm that erupted when contamination in one company’s factory cut the supply of flu shots in half was further evidence of how vulnerable the nation is to the decisions and misfortunes 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 solve the problem.
“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 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 Waxman, D-Calif., said recently. “I don’t care how they solve it – they should just solve it.”
The ranking Democrat on the Government Reform Committee, Waxman said he is 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. One of the companies, however, said its problem is not with “revenue recognition” but with the details of managing the vaccine inventory.
Other parties were reluctant to discuss possible solutions or who, if anyone, is to blame for the empty shelves. The SEC, which enforces accounting practices, would not speak on the record. HHS officials would not make available the person talking to the SEC on the matter. The department referred questions to its subordinate agency, the CDC, whose officials said important decisions about the stockpile are being made at the department level.
The firms that have stopped selling vaccine into the stockpile provided some information, although Merck & Co. Inc., the one company still making new contracts with CDC, was silent.
The stockpile’s usefulness is not theoretical.
The government has gone into it nine times since 1984, the year after it was established. This was done to get vaccine for immediate use in a disease outbreak, or to prevent supply disruptions when a manufacturer had production problems or shut down a plant.
In January 2002, the government withdrew 700,000 doses of MMR vaccine when Merck, the manufacturer, had problems at a factory.
In August 2003, the CDC used 46,000 doses to fight a measles epidemic in the Marshall Islands.