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American Home's Diarrhea Vaccine Loses Approval; Study Links Deaths

October 25, 1999

American Home Products Corp.'s diarrhea vaccine would have killed 12 to 20 infants a year -- about as many lives as it was predicted to save -- if it had been given to every American infant, according to an emergency government study.

The study prompted the vaccine-advisory panel of the U.S.  Centers for Disease Control and Prevention to withdraw its approval Friday of the vaccine, called RotaShield. Last week, American Home took RotaShield off the market; it was the first time a vaccine had been withdrawn from the U.S. market for safety concerns.

About one million infants were immunized with RotaShield between its approval in September 1998 and its suspension from  use in July. Two children died, 53 needed surgery and another 47 required medical care after contracting bowel obstructions following vaccination with RotaShield.

Whether all of these cases resulted directly from RotaShield may never be known, but the study unveiled Friday suggested that many of them did. It found that the risk of serious bowel obstruction was 20 to 28 times higher in children younger than five months who took the vaccine compared with identically aged children who weren't vaccinated.

The study found that bowel obstructions were most likely to occur in the first week following the first dose of RotaShield. But vaccinated children had increased risk of bowel obstructions for weeks.

The findings led one member of the advisory panel to say parents might lose trust in the government's ability to pick safe vaccines.  "We've got a bit of a black eye here and a possible problem with future confidence of vaccines," physician Charles Helms said.

In addition to the deaths, John Livengood, director of the epidemiology and surveillance division of the National Immunization Program, said that routine immunization with RotaShield would likely have caused about 850 nonfatal cases per year of intussusception, a bowel obstruction so severe that the intestine swallows itself like a collapsing telescope. Many of those 850 cases would have required surgery.

Millions more children could have been exposed to RotaShield, but the government had yet to conclude negotiations with American Home for large purchases of the vaccine. Nearly four million infants receive vaccinations every year in the U.S. Most get their vaccines free as a result of government purchases.

RotaShield was created to prevent the often-severe diarrhea that follows a child's first exposure to rotavirus infection. In the U.S., 55,000 children are hospitalized annually and 20 to 40 die  from the dehydration that can result after a rotavirus infection. In the developing world, an estimated 600,000 children a year die of the disease.

Even without vaccination, all of these children could be saved from hospitalization and death if parents gave rehydration supplements, available in most U.S. pharmacies, to children affected by severe diarrhea.

Since these supplements, along with emergency medical care, are often hard to find in the developing world, RotaShield likely would prevent many more deaths in the Third World than it would cause. For this reason, Paul Gargiullo, an official with the World Health Organization, begged the advisory panel Friday to refrain from condemning or banning the development of other rotavirus vaccines. "Don't close the door," he said.

Several advisory panel members expressed the hope that work would continue on the development of other rotavirus vaccines. Peter Paradiso of American Home, Madison, N.J., said the   company will continue to work to prevent rotavirus diarrhea.

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