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The Vaccine Crisis
Marilyn Webber, National Journal, 4-1-06

Webber has crafted an excellent overview of America's troubling vaccine shortage, and its implications for our ability to counter potential bioterror attacks and natural pandemics.

To the dismay of public health officials, vaccine shortages have become routine in the United States. Most vaccines now come from only one producer, and that leaves no margin of error when things go wrong in the production process&3151;and they sometimes do. Between 1998 and 2004, nine of the 12 vaccines routinely given to children were in short supply at one time or another. The Centers for Disease Control and Prevention reported shortages of vaccines for chickenpox, diphtheria, flu, measles, mumps, pertussis, rubella (German measles), pneumococcus, and tetanus.

Over the past three decades, the vaccine infrastructure in the United States has steadily crumbled, and as Americans learn more about the deadly avian flu, concern about vaccine availability has escalated to fear, and even panic. The companies that would make vaccines for pandemic flu are the same ones that make seasonal flu vaccines, and only one of those suppliers—Sanofi-Pasteur, the vaccine division of Sanofi-Aventis—makes it entirely in the United States.

"We have very limited manufacturing capacity right now as a world or as a nation" to make flu vaccine, Bruce Gellin, director of the national vaccine program office at the Health and Human Services Department, told National Journal. And many experts worry that in the event of a pandemic, flu vaccine makers in other countries would be forced to keep their supplies at home.

Exposure to crushing product liability lawsuits, high-development and testing costs, and government price controls have all played a part in driving vaccine manufacturing out of the U.S. A number of policymakers—including Republican Senator Bill Frist and Democratic Senator Joe Lieberman—have proposed potential solutions, including protection from lawsuits, government tax credits, or even patent extensions. To date, however, consensus on a broad program of reforms has eluded lawmakers.

Project FDA.
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