Rotavirus Vaccine Linked to Risk of Infant Bowel Obstructions: Study

A common rotavirus vaccine, offered to millions of children each year, may be linked to an increased risk of serious bowel obstruction among infants, according to the findings of new research.

In a study published this week in the New England Journal of Medicine, researchers indicate that side effects of rotavirus vaccine RotaTeq has been linked to intussusception, which is a form of bowel obstruction that can occur in infants.

Intussusception may cause severe gastroenteritis, inflammation of the stomach and intestines, watery diarrhea and vomiting and may result in hospitalization.

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Researchers studied infants four weeks to 34 weeks of age enrolled in six integrated health care organizations involved in the Vaccine Safety Datalink (VSD) project. They reviewed the medical records of children who received vaccinations from April 2008 to March 2013, checking for signs of intussusception seven days after receiving a rotavirus vaccination.

The study, which was funded by the U.S. Centers for Disease Control and Prevention (CDC), reviewed the cases involved in nearly one and a half million doses of rotavirus vaccines, from two separate vaccine brands. The first, RotaTeq, manufactured by Merck, which is given in three doses between six weeks and 32 weeks of age. The second Rotarix, manufactured by GlaxoSmithKline, is given in only two doses between six and 23 weeks of age.

RotaTeq was linked to 1.5 excess cases of intussusception per 100,000 children. Rotarix, however, was associated with 5.3 excess cases of bowel obstruction for every 100,000 infants, after the children received two doses of the vaccine.

“We observed a significant increase in the rate of intussusception after vaccination, a risk that must be weighed against the benefits of preventing rotavirus-associated illness,” wrote study authors.

Previously, a vaccine known as RotaShield was the common vaccination offered in the United States. It was used until it was pulled from the market in 1999 after a study found RotaShield had an increased risk of bowel obstruction, about one to two excess cases per 10,000 children.

This new study suggests that bowel obstruction side effects RotaTeq appear to pose about one-tenth the risk that was associated with RotaShield. However, Rotarix, while still a lower risk than the older RotaShield, offered a heightened risk above RotaTeq.

Researchers warn the benefits of receiving the vaccine still outweigh the risks of bowel complications, which may include viral infection and hospitalizations for many new borns. Health experts estimate the vaccine will prevent approximately 50,000 hospitalizations each year.

Doctors advise, if you notice your infant pulling their knees to their chest, suffering from severe colic or blood in the stool within seven days following administration of the vaccine, immediately go to the emergency room.

Study authors warn that this does not offer sufficient reason to bypass or decline the vaccine completely. It is a study which should be followed up with more research.

Rotavirus is the leading cause of severe diarrhea in infants and young children worldwide each year. It will cause more than half a million deaths in children younger than five years old.


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