October 25, 2007

Updated safety data on rotavirus vaccine reported intussusception cases fall below expected range

Updated data on the administration of RotaTeq® to infants in the US were presented to the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) at its meeting today. Consistent with previous analyses, the rate of intussusception in infants receiving RotaTeq® was not greater than expected by chance alone, indicating that the vaccine does not pose an elevated risk for intussusception. Intussusception is the most common cause of bowel obstruction in infants, and increased risk of intussusception appeared to be linked to an earlier rotavirus vaccine withdrawn from the market in the United States in 1999.

Between March 2006 and August 2007, 9.1 million doses of RotaTeq® were distributed in the US, and ongoing, routine surveillance confirmed 160 cases of intussusception-a rate below the expected background occurrence. Of these 160 cases, 47 were reported within three weeks of the infant receiving a vaccine dose. In an unvaccinated population of the same age, the number of expected cases would be approximately 150.

Additionally, the CDC's Vaccine Safety Datalink, which conducts active surveillance of insured children, stated "no evidence of increased risk," after review of more than 100,000 vaccinations revealed only three reports of intussusception. The cases observed fall below the expected baseline rate of 3.4 cases in the same size population.

Based on ACIP recommendations, CDC policy calls for routine immunization of all US infants with three doses of RotaTeq® administered orally at 2, 4, and 6 months. Click here to read the ACIP's current recommendation on rotavirus vaccines. Presentations and minutes from this week's meeting will be posted to the ACIP website in coming weeks. 

 The PATH Rotavirus Vaccine Program is supported by the GAVI Alliance.