- Copyright © 2010, The American Academy of Pediatrics
A safety monitoring study of the rotavirus vaccine Rotarix conducted by the manufacturer GlaxoSmithKline in Mexico noted a higher rate of cases of intussusception in infants than was expected. The increase in cases was seen during the first week after infants received their first dose of the vaccine.
The Food and Drug Administration (FDA) has added information to the Rotarix vaccine label to inform health care providers about preliminary results from this study.
The Centers for Disease Control and Prevention continues to recommend Rotarix to prevent rotavirus, the most common cause of severe diarrhea among infants and young children. The risk of intussusception found in the Mexico study is much lower than the risk of severe rotavirus disease in U.S. children who do not receive rotavirus vaccine.
For the United States, the findings from the Mexico study translate to potentially 0 to 4 additional cases of intussusception hospitalizations per 100,000 infants within 31 days of receiving the first dose of Rotarix. This takes into consideration the background rate of intussusception hospitalizations in the United States, which is approximately 34 in 100,000 infants per year. This study was conducted in a population of Mexican infants with a background rate of intussusception that is 2-3 times higher than what is seen in infants in the United States (rate in Mexican children is 60 to 90 in 100,000 infants per year).
A second rotavirus vaccine, RotaTeq made by Merck, is available in the United States.
For more information, visit: