- The Washington Times - Monday, February 9, 2004

The recent shortage of flu shots received much attention, but vaccine stocks have also dwindled in the past few years for such diseases as meningitis, mumps, measles and diphtheria.

The problems with supply are blamed on a number of interrelated factors — the low prices the federal government pays for childhood vaccines, the dwindling number of vaccine producers, and others.

For doctors, regardless of the cause, the effect is the same. Last fall, New York pediatrician Dr. Elihu Sussman ordered 40 doses of pneumococcal conjugate vaccine (PCV), which protects against deadly meningitis, bloodstream infections and pneumonia in young children.

But after waiting a month, he received only five.

“Wyeth [the sole manufacturer of PCV] said there were problems in the manufacturing process and that they were allocating on the basis of [a provider’s] orders in the last six months,” Dr. Sussman said in a telephone interview,

“We raised a whole lot of stink [about the allocation policy], and Wyeth wound up releasing to me the other 35 doses I ordered … but they told me not to call again” for several months with any further orders, he added.

Dr. Sussman is not alone.

Repeated warnings

The American Academy of Pediatrics (AAP) announced Dec. 19 that PCV Prevnar is being apportioned. The academy further warned that there could be changes in the vaccination schedule against the life-threatening infections if widespread vaccine shortages occur.

These types of infections annually strike 250 children per 100,000, ranging in age from 6 months to 2 years.

Less than a week later, Wyeth announced its vaccine production was adequate, and it released 1.4 million doses of Prevnar, according to Dr. Keith Powell, a member of AAP’s Committee on Infectious Diseases.

He noted that research has shown that the vaccine, which was introduced in 2000 and costs about $40 per dose for the recommended four-dose treatment, was responsible for a 69 percent decrease in invasive diseases in children under age 1 in 2001.

“Wyeth now expects to be able to meet demand, but it’s run into some problems with bottling that could mean continued distribution problems,” said Dr. Powell, a pediatrician at Children’s Hospital of Akron, Ohio.

Douglas Petkus, a Wyeth spokesman said, “There was a bottleneck over time, but we are supplying 100 percent of a [provider’s] historical monthly average of orders.”

He said having to revamp the vaccination schedule is unlikely.

The General Accounting Office (GAO), the investigative arm of Congress, warned of continued shortages of childhood vaccines in a report released in September 2002.

The National Vaccine Advisory Committee made the same prediction in a report released Dec. 16, which was published in the Journal of the American Medical Association.

“Beginning in late 2000, significant unprecedented and unanticipated shortages of routinely administered vaccines against eight of 11 vaccine-preventable childhood infectious diseases occurred in the United States,” said the 15-member panel, established in 1988 to advise government policy-makers on vaccines.

“Disruptions to the supply of routinely administered vaccines are likely to continue to occur. Action to implement short- and long-term solutions should be considered and implemented now,” said the panel, whose members included vaccine manufacturers, doctors, parents, and state and local health officials.

The advisory committee’s report addressed shortages in eight of 11 vaccines recommended beginning in infancy. Those in short supply have been vaccines for chickenpox, mumps, measles, pertussis (whooping cough), tetanus, diphtheria, rubella (German measles) and pneumonia.

Vaccines that have not been in short supply are those for polio; Hepatitis B; and Haemophilus influenzae, a bacterium that can cause meningitis in children, acute respiratory infections and conjunctivitis.

Panicked demand

When the advisory committee’s report was released, many Americans were in a panic about their inability to find a vaccine to immunize their children against influenza in a flu season that has been especially deadly for children. Flu shots are recommended for children 6 months to 23 months, and for other children with chronic illnesses.

According to Dr. Bruce Gellin, the director of the federal government’s National Vaccine Program Office in Washington, the number of Americans getting immunized against influenza has grown “three- or four-fold” in the past decade.

“But until the current flu season, the level of supply always exceeded demand. But for this flu season, there was excess demand beyond any demand we’ve ever seen for vaccine against influenza,” Dr. Gellin said.

Key reasons for this unusual demand, he said, were the early start of the flu season last year and the increased recognition that influenza can kill. The Centers for Disease Control and Prevention (CDC) said the flu kills an average of 36,000 Americans annually.

The GAO report noted that “unanticipated demand,” which it described as “record-breaking” in the first months after PCV became available, was responsible for initial shortages of the vaccine, which continued for three years. The GAO said the demand came after an “extensive education campaign” before the vaccine became available.

Dr. Gellin said the introduction in the 1980s of a vaccine that prevents infection with the bacillus, Haemophilus influenzae, “essentially eliminated” a type of childhood meningitis caused by that microbe.

“With that gone, pediatricians feared pneumococcal meningitis” and advocated use of the vaccine against that disease, he said.

Costly venture

“The U.S. vaccine system has some good things going for it, but it also has some important deficiencies,” said Frank Sloan, a professor of economics at Duke University, who chaired an Institute of Medicine (IOM) committee that in August issued a report, “Financing Vaccines in the 21st Century.” The IOM is affiliated with the National Academy of Sciences.

Mr. Sloan said money — notably the low prices the federal government pays for childhood vaccines — is a primary factor in many of the vaccine shortages that have plagued the country.

“We’re using a lot of old vaccines that are very cheap, only a dollar or so a dose,” Mr. Sloan said in a telephone interview. “The government tries to get low prices, which discourages research and development [into new vaccines].”

The IOM report found that vaccines are not very important to drug companies financially, because only 1.5 cents per dollar of drug-company revenue comes from vaccines. The report urged that financial incentives be offered to stimulate new vaccine development.

Mr. Sloan said undoubtedly, the low prices paid for vaccines played a role in the manufacturing glitches that, for a time, stalled Wyeth’s production of pneumococcal conjugate vaccine.

“Because of the prices being paid, some firms are not putting enough resources into production,” he said.

And few companies are making vaccines these days. In 1967, about 30 U.S. firms manufactured vaccines. But now there are only five, according to the IOM report.

In the 2002-03 flu season, three companies — Wyeth, Chiron Corp. and Aventis-Pasteur — made a vaccine. But because millions of doses were left over at the end of that season and the influenza vaccine can be used only one season, Wyeth dropped out. So only two firms made the vaccine that was in such short supply this season. And that vaccine did not provide full protection against the Fujian strain of influenza virus responsible for most of the deaths and serious illnesses in this year’s epidemic.

Necessary changes

Recent vaccine shortages have necessitated temporary changes in the recommended immunization schedule and have caused states to scale back vaccination requirements. In a survey of 64 state, local and territorial immunization programs, the GAO said all 52 that responded said they had experienced shortages of two or more vaccines and have taken action to deal with them.

Thirty-five states, including Minnesota, South Carolina and Washington, reported putting into effect new requirements that allowed children receiving fewer than the recommended number of immunizations to attend school, the GAO found.

Central to the availability of childhood vaccine, or lack thereof, is the federal Vaccines for Children Program (VFC), established in 1993.

Robert Goldberg, director of the Manhattan Institute’s Center for Medical Progress, describes VFC as “Hillary Clinton’s dry run for national health care,” because she was a leading advocate of the program.

“The vaccine program buys up nearly 70 percent of all childhood vaccines at government-set prices and then distributes them to states according to a federal formula. The result is … vaccines have gone to where the outbreaks aren’t, and price controls have discouraged vaccine makers from producing more than what the government orders,” Mr. Goldberg wrote in a column published in The Washington Times.

The IOM report makes it clear that VFC has not been cheap.

“Government vaccine expenditures are growing rapidly. Funding for the Vaccines for Children entitlement program jumped from $500 million to $1 billion between 2000 and 2002, with the addition of new vaccine products to the recommended childhood schedule,” it said in an executive summary.

“CDC negotiates large purchase contracts with manufacturers and makes the vaccine available to public immunization programs under VFC,” stated a report by GAO on the VFC system.

VFC provides vaccines for certain children, including those eligible for Medicaid and the uninsured, the report said. It points out that participating public and private health care providers obtain vaccines through VFC at no charge.

A second program, created under Section 317 of the Public Health Service Act, provides project grants for preventive health services, including immunizations. The GAO says CDC currently supports 64 state, local and territorial immunization programs.

Altogether, about 50 percent of all the childhood vaccines administered in the United States each year are obtained by public immunization programs through CDC contracts, the GAO report said.

The federal government not only has a role as the “largest purchaser of vaccines in the country,” according to the GAO, but the Food and Drug Administrates licenses all vaccines sold in the United States and regulates the vaccine industry.

“The federally price-controlled bulk purchase of vaccines has decimated the vaccine industry. Vaccine prices have remained stagnant since 1994, while new regulations and lawsuits have driven up the cost of producing old vaccines and developing new ones,” Mr. Goldberg wrote.

Dr. Powell of the AAP cites several “major problems with the vaccine market,” including the small number of manufacturers, low profit margins and the time required for vaccine production.

“Some vaccines take a year to produce,” he said.

“Funding for the Vaccines for Children program has been responsive to the introduction of newer vaccines, but the government negotiates at very low prices. And the industry says it needs new markets,” Dr. Powell added.

Dr. Powell says he fully agrees that there will be further critical shortages of life-saving childhood vaccines. “I do believe that, because we haven’t changed the infrastructure in any significant way to alleviate the problems,” he said.

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