American Home's Diarrhea Vaccine Loses Approval; Study Links Deaths
October 25, 1999
By GARDINER HARRIS
Staff Reporter of THE WALL STREET JOURNAL
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Home took RotaShield off the market; it was the first time a vaccine had been withdrawn from the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
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
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
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
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.