Senate hearing examines vaccine shortage

WASHINGTON, Sept. 17 (UPI) -- A shortage of childhood vaccines in the United States seems to have improved temporarily after 18 months, although the nation remains vulnerable to future disruptions if the vaccine supply cannot be increased, a new government report concludes.

The report, released by the General Accounting Office on Tuesday and requested by the U.S. Senate last January, suggested difficulties within the vaccine manufacturing industry have contributed to this public health problem.

"Physicians have been forced to turn away young patients," said Sen. Jack Reed, D-R.I., chairman of the Health, Education, Labor and Pensions subcommittee on public health, at a hearing on the issue. "State and local public health officials have been left scrambling for vaccine supplies," Reed said. "School departments have had to waive immunization requirements for entry, leaving young children vulnerable to potentially devastating -- yet entirely preventable -- diseases such as measles, rubella, and even chicken pox."

Although problems within the vaccine manufacturing industry had a direct effect on some children having to forgo immunizations, the shortage had multiple causes, said Jan Heinrich, GAO's director of health care and public health issues. Nevertheless, "the vaccine supply remains vulnerable to disruptions in the future," Heinrich told senators.

One problem is the lengthy vaccine production schedule, which prevents manufacturers from responding in a timely fashion to changes in demand.

Another problem, Heinrich explained, is so few companies in the United States make the vaccines. If one company suffers production difficulties -- such as failing inspection regulations -- or decides for whatever reason to withdraw its product from the market, the health care system is left searching for alternatives.

Reed pointed out there are only four major manufacturers producing almost all of the vaccines American children need. One of those companies is Aventis Pasteur North America, located in Swiftwater, Pa. Its executive vice president, Wayne Pisano, told the subcommittee vaccines the small number of manufacturers makes the vaccine supply quite susceptible to fluctuations in the business, and federal programs to keep vaccine price tags low "may provide short-term savings for the government," Pisano said, "but ultimately contribute to the supply problem."

While the vaccine industry has been trying re-balance supply and demand, school children throughout the country have been skipping routine vaccinations. For example, according to the report, the Minnesota Department of Health suspended school and post-secondary immunizations laws for the tetanus-diphtheria vaccine and diphtheria booster shot for a second consecutive year. The suspension extends into the 2002-2003 school year, which just got underway.

South Carolina and Washington State also allowed children to attend day care facilities or school when they had not received all of their immunizations, the report said. Immunizations also may vary greatly from state to state, Heinrich explained, because each jurisdiction can follow its own vaccination policies.

"The real life impact of these shortages can not be denied," Timothy Dolan, a pediatrician from Baltimore who spoke on behalf of the American Academy of Pediatrics.

"An estimated 11,000 babies are born each day in the United States, each requiring 20 doses of vaccine by age 18 months to be protected against 11 childhood diseases, Dolan said. "A vaccine shortage quickly impacts thousands of families every day."

Sen. Patty Murray, D-Wash. echoed that finding. "I know that in Washington state shortages have resulted in delays that may cost lives," she said. "My state recently announced that there are no longer any shortages of required childhood immunizations. However, meeting the needs of 'catch up' kids ... could still result in delays."

Murray asked Heinrich if the GAO had found any evidence delays in childhood vaccinations had resulted in a spike in infectious diseases. Heinrich responded the GAO had no such evidence, adding if any such illnesses have occurred, it will take time before they can be reported and documented. "There will always be a lag time in the reporting of infectious diseases," Heinrich said.

Although the shortage problem appears to have abated temporarily, Heinrich said, the federal government sorely needs to develop an overall strategy to prevent another lapse. Congress appears interested in doing just that. Sen. Bill Frist, R-Tenn., and one of the lawmakers who requested the GAO report, said the findings are proof the federal government needs to pass legislation before adjourning in a few months.

Frist has proposed the Improved Vaccine Affordability and Availability Act, which seeks to expand the vaccine market, stabilize the vaccine supply, and provide wider access to inoculations.