To be considered by the FDA - possible risk associated with the vaccine, weighed against 95,000 U.S. emergency room visits annually by parents with infants sick from rotavirus, 227,000 trips to the doctor and 600,000 _deaths_ worldwide from this disease. Some think excessive caution in the case of an earlier rotavirus vaccine had a deadly result:

"A tragic example...is the case of RotaShield, a vaccine made by American Home Products (now Wyeth). Launched in 1998, RotaShield was considered nothing less than a godsend by infectious-disease specialists. It was virtually 100% effective in preventing rotavirus--an omnipresent diarrhea-causing virus that directly leads to 600,000 deaths a year, nearly all of them children in the developing world. Selling for a little over $100 for a complete three-dose regimen, it was quickly taken up in the U.S. schedule for childhood vaccinations. Within a year some 1.5 million American children had been inoculated.

But during this time, government researchers caught sight of what looked to be a serious problem. In children who were vaccinated, the occurrence of a rare bowel obstruction was higher than in the general population--by a rate of one to two cases per 10,000. That prompted the U.S. Centers for Disease Control to withdraw its endorsement for the vaccine and the FDA to encourage the company to remove it from the U.S. market. Wyeth soon abandoned the whole effort.

Now, six years later, two of Wyeth's rivals, Merck and GlaxoSmithKline, have launched new rotavirus vaccines. A pair of studies published in January in the New England Journal of Medicine, involving massive and phenomenally expensive trials of more than 60,000 patients each, showed the new vaccines to be safe and effective; there was no evidence of increased risk for bowel obstructions. Merck's vaccine was approved by the FDA on February 3; Glaxo's is likely to be soon. So you could argue that the system worked as well as it was supposed to: A dangerous vaccine was withdrawn, and drugmakers went back to the lab to cook up a better medicine.

But consider the cost of not having the vaccine during those six years: An estimated 3.6 million children have been lost worldwide to a preventable disease. (In the U.S., where rotavirus is rarely deadly, it still results in some 95,000 annual trips to the emergency room and 227,000 doctor visits for children under age 5.) And if 3.6 million deaths weren't tragic enough, further study has led some researchers to believe that the 1999 vaccine may not have caused the rare bowel obstruction after all: The complication sometimes occurs for no known reason.

In addition to its appalling human cost, the rotavirus saga illustrates the regulatory pressures vaccine makers face. In 1967, according to the Institute of Medicine in Washington, D.C., there were 26 U.S. producers of vaccines; in 2003 there were five. A clear reason for the decline is that the high cost of gigantic trials and impossible expectations of risklessness push drugmakers toward investing in something else."


http://money.cnn.com/magazines/fortune/fortune_archive/2006/02/20/8369155/ind...


More perspective on the human cost of rotavirus infection:


http://www.globalhealth.org/reports/report.php3?id=266