Kids’ Diarrhea Vaccine Appears Safe After All: Study

TUESDAY, Feb. 7 (HealthDay News) — Despite earlier research that
suggested the rotavirus vaccine increased the risk of intussusception
when a portion of the intestine slides forward into itself — a large new
study finds this is not the case.

“The findings of our study are reassuring and add to the evidence that
the benefits of rotavirus vaccine, in terms of reducing doctor’s visits
hospitalizations and deaths from rotavirus disease, is far greater than
any low-level risk for intussusception that may exist,” said lead
researcher Irene Shui, a postdoctoral fellow at Harvard Medical School and
Harvard Pilgrim Health Care Institute in Boston.

In 1999, the first rotavirus vaccine was taken off the U.S. market due
to increased risk of intussusception. But the U.S. Food and Drug
Administration has since approved two new vaccines to prevent the
infection — Rota Teq in 2006, and Rotarix in 2008.

Before the introduction of rotavirus vaccine, rotavirus disease
occurred in the majority of young children, causing a substantial public
health burden from severe cases of diarrhea, Shui said.

“Since its introduction, health care utilization for diarrhea has
decreased dramatically and more than 50,000 hospitalizations a year in the
United States due to rotavirus have been prevented,” she said.

The study appears in the Feb. 8 issue of the Journal of the American
Medical Association
.

For the study, Shui’s team looked at the risk of intussusception from
the vaccine, focusing on the first week after the first dose of the
vaccine was given.

Included in the study were infants aged 4 weeks to 34 weeks who were
given the vaccine between May 2006 and February 2010. In all, this
included almost 800,000 doses of the vaccine.

The researchers found no statistically significant increased risks for
intussusception in either the month or week after the vaccine was
given.

In the month following vaccination, there were 21 cases of
intussusception compared with 20.9 expected cases. For the week following
vaccination, there were four cases compared with 4.3 expected cases, the
researchers found.

That works out to a risk of one case of intussusception for every
65,287 vaccine doses. The risk might even be lower, the researchers
added.

Recent reports from international studies in Mexico and Australia found
some evidence for a low-level risk, especially in the week following the
first dose of vaccine, Shui said.

That’s because intussusception is rare and cases may be due to chance
and not the vaccine, or due to genetic variations in populations where the
vaccine was tested, the researchers noted.

“Given the rarity of intussusception, we cannot rule out that a small
excess risk may exist following vaccination; however, this potential
low-level risk is far smaller than the overall benefits from the vaccine,”
Shui said.

Intussusception is a serious condition in which one part of the large
or small intestine slides into another part, which can block food or fluid
from passing through. Intussusception also cuts off the blood supply to
the part of the intestine that’s affected. However, with prompt detection
and treatment, almost all patients recover, Shui said.

Commenting on the study, Dr. Jeffrey Brosco, a professor of clinical
pediatrics at the University of Miami Miller School of Medicine, said that
“it confirms what we already know. The benefits of the rotavirus vaccine
far outweigh the risks.”

The vaccine drastically reduces rotavirus infections that cause
vomiting and diarrhea, he said. “It prevented about 55,000
hospitalizations in the United States in 2008 alone.”

Outside the United States, it’s even more important, Brosco said. “Here
kids get hospitalized and get better, but across the world it’s one of the
leading causes of death for infants,” he noted.

Children should get three doses of this oral vaccine at 2, 4 and 6
months of age, Brosco said. “It’s very safe and effective, and parents
needn’t worry,” he added.

The study was supported in part by the Vaccine Safety Datalink contract
with American Health Insurance Plans, funded by the U.S. Centers for
Disease Control and Prevention.

More information

For more information on rotavirus, visit the U.S. Centers
for Disease Control and Prevention
.

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