Feb. 26, 2001 (Ivanhoe Newswire) -- An oral rotavirus
vaccine formerly approved by the Food and Drug Administration (FDA) may cause a
form of intestinal blockage, known as intussusception, in healthy infants.
Rotavirus causes severe inflammation of the stomach and
intestinal lining and affects some 3.5 million young children in the United
States each year. The most serious cases of infection account for 50,000
hospitalizations and 20 deaths in the United States annually, though children
in developing countries are at greatest risk for severe rotaviral illness.
On August 31, 1998, the FDA approved the tetravalent
rhesus-human reassortment rotavirus vaccine (RRV-TV) for infants and
recommended doses at 2, 4, and 6 months of age. Use of RRV-TV was later
suspended when an increased occurrence of intussusception was reported among
recently vaccinated infants. Intussusception is caused by the inward folding of
one segment of the bowel into another.
To assess whether a connection exists between RRV-TV and
intussusception, investigators from the Centers for Disease Control and
Prevention in Atlanta performed analyses of the medical records and histories
of infants with intussusception and healthy infants of the same age. Of these
subjects, 17.2 percent of infants with intussusception and 12.5 percent of
healthy infants were previously vaccinated with RRV-TV.
The findings, reported in the current issue of the New England
Journal of Medicine, support an increased risk of intussusception three to 14
days after the first dose of the vaccine. The authors of the report estimate
that a national program of vaccination with RRV-TV would result in one case of
intussusception due to the vaccine for every 4,670 to 9,474 infants vaccinated.
Authors of the study conclude, “The strong association
between vaccination with RRV-TV and intussusception among otherwise healthy
infants supports the existence of a causal relation. Rotavirus vaccines with an
improved safety profile are urgently needed.”
Copyright © 2001 Ivanhoe Broadcast News, Inc.
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