Article

Rotavirus infection, a gastrointestinal illness that can cause severe diarrhea and vomiting, is linked to 25 million doctor visits, 2 million hospitalizations, and more than half a million deaths in children worldwide each year. In 1999, a vaccine to prevent rotavirus infection was pulled from the market because the children who received it had an increased risk of developing intussusception, a type of bowel obstruction. The results of two recent studies of newly developed rotavirus vaccines indicate that this dangerous infection can be prevented without increasing the risk of intussusception.

In the first study, researchers divided 6- to 12-week-old infants into two groups. One group of 34,035 infants received three doses of a rotavirus vaccine; the other group of 34,003 infants received an inactive placebo (the health care professionals who administered the doses didn't know whether each child received the vaccine or the placebo). Over the course of the next year, the infants were monitored for health problems and rotavirus infection.

After infants had received the third dose of vaccine, hospitalizations and emergency department visits for rotavirus infection were reduced by 95%. Of children who had been vaccinated, 75% experienced complete protection from rotavirus infection, and the vaccine prevented 98% of severe rotavirus cases. In addition, the vaccinated infants did not have an increased risk of intussusception or other side effects.

In the second study, researchers studied 63,225 infants from Latin America and Finland. At 2 and 4 months of age, the infants received either a rotavirus vaccine or a placebo; doctors monitored the infants for side effects for at least 4 months afterwards.

The rotavirus vaccine proved to be at least 85% effective against severe rotavirus infection, and hospitalizations due to rotavirus infection were significantly reduced. As in the previously mentioned study, the risk of intussusception was no greater in infants receiving the vaccine.

What This Means to You. Newer rotavirus vaccines have the potential to drastically reduce rotavirus infection and hospitalization, without increasing the risk of intussusception associated with older vaccine formulations. If you want more information about the rotavirus vaccine and whether your child should receive it, talk to your child's doctor.

For more information about rotavirus, strategies to prevent it, and the recent FDA approval of RotaTeq, see FDA Approves Rotavirus Vaccine.

Sources: Study 1: Timo Vesikari, MD; David O. Matson, MD, PhD; Penelope Dennehy, MD; Pierre Van Damme, MD, PhD; et al., New England Journal of Medicine, January 5, 2006.

Study 2: Guillermo M. Ruiz-Palacios, MD; Irene Pérez-Schael, MSc; F. Raúl Velázquez, MD; Hector Abate, MD; et al., New England Journal of Medicine, January 5, 2006.

Reviewed by: Steven Dowshen, MD
Date reviewed: March 2006