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When 23 companies used to produce vaccines, why are there only two now? There was a set-to by Sens. Frist and Clinton about vaccines last year. The basic issues that affect vaccine shortages follow.

Extracts from INFECTIOUS DISEASES IN CHIDREN, Dec 2002, article by Bryan Bechtel

"Vaccines have traditionally been high-risk, low-profit ventures for pharmaceutical companies. Investors tend to shy away from vaccines because they require extensive and expensive clinical testing before licensure and tend to favor projects on potential blockbuster drugs.

"The idea of government owned or sponsored manufacturing has been proposed as one strategy, but the pharmaceutical industry has largely rejected that idea, saying it would be redundant and unnecessary. Instead, several advisory panels have suggested incentives or tax-breaks to manufacturers to keep them interested in making vaccines.

"The costs of bringing a new vaccine to market can be astronomical, but they pale in comparison to the risks companies face when those products reach consumers. There has been anecdotal evidence that cost of investment has kept some smaller biotechnology companies from participating in vaccines, but it is a well known fact that fear of liability has caused some pharmaceutical companies to drop out of the market.

"Congress created the Vaccine Injury Compensation Program to adjudicate claims of vaccine harm in 1986 after years of contentious litigation led some companies to stop production of vaccines. The program pays claims based on a predesigned table without the need for trial by jury.

"But now, trial lawyers have found unique ways to circumvent the process, particularly with thimerosal litigation. Several lawsuits claim thimerosal to be a contaminant, not a preservative, and therefore, not covered by the injury table, while several class-action suits seek money for medical monitoring. However, a new provision to the Homeland-Security Bill will block these claims.

"Another suggestion is a review of the regulatory process to make licensing vaccines more predictable and to make sure manufacturers stay compliant with current Good Manufacturing Practices (GMP). Supplies of several vaccines, including MMR and varicella (Varivax, Merck) and some formulations of hepatitis B vaccine became scarce after FDA inspections found issues with manufacturing conditions.

"Pharmaceutical companies have complained that the FDA’s current GMP are ambiguous and difficult to interpret. Meanwhile, the FDA has said that its standards are intentionally vague so they can be dynamic and reflect the latest advances in technology.

"The FDA’s licensing review process has also come under fire. While not a direct cause of vaccine shortages, regulatory requirements have made it difficult for companies to maintain viability and may be a disincentive for new companies to enter the market."

I, too, remember Hilary calling vaccine profits "obscene". I also remember a huge government stockpile of vaccine going bad in New Jersey in the nineties. Is there also a link with the anthrax and smallpox vaccine problems?