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Commentary

Why Are Pharmaceutical Companies Gradually Abandoning Vaccines?
Paul A. Offit, Health Affairs, 5-1-05

Vaccinations for preventable diseases are amongst the most cost-effective health expenditures a society can make. Why, then, has the number of vaccine manufacturers fallen steadily in recent decades, from “twenty six in 1967 to seventeen in 1980 and to five in 2004”.

Offit delivers an eloquent catalogue of the many disincentives plaguing vaccine production, from low prices in the federal Vaccines for Children Program to liability concerns. But two factors that deserve much more sustained discussion are the rising costs of regulatory compliance, and risk-aversion at the FDA:

The cost to develop and make many vaccines is greater than that to make most drugs, because products given to healthy people are often held to higher standards of safety than to those given to people who are sick. In 1998 the FDA licensed a vaccine to prevent rotavirus, a common cause of fever, vomiting, and diarrhea in young children. After the vaccine had been on the market for one year—and was given to about one million—children—the CDC detected a rare adverse event: About one of every 10,000 children who received the vaccine developed intussusception, a blockage of the intestine. As a consequence, the rotavirus vaccine was withdrawn. …
Following the withdrawal of the rotavirus vaccine in 1999, children have continued to be hospitalized for and killed by the rotavirus. Although many more children would have been helped by a rotavirus vaccine than hurt by it, the current culture does not allow for any serious side effects from a vaccine. …

New rotavirus vaccines are under development by Merck and GlaxoSmithkline, but in large and expensive “pre-licensure trials that include more than 140,000 children” and cost about $400 million. Other reforms are undoubtedly necessary to boost vaccine production—but one of the first things we should do is reassess the cost-effectiveness of regulations governing vaccine approval.



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