Rotavirus Vaccine

Rotavirus is the leading cause of severe diarrhea and dehydration in young infants worldwide.  It is estimated to be responsible for the deaths of more than 500,000 infants around the world each year, primarily in low- and middle-income countries.  Before the introduction of a rotavirus vaccine, rotavirus resulted in an estimated 55,000-70,000 hospitalizations and dozens of deaths in the U.S. each year.  To learn more visit Rotavirus and Rotavirus Vaccination.

Currently, there are two licensed rotavirus vaccines in the US:

• Rotarix. The FDA licensed this vaccine in 2008. In March 2010, FDA scientists confirmed the presence of porcine circovirus 1 (PCV1) in Rotarix. PCV1 is not known to cause illness in humans or other animals. As a precautionary measure, on March 22, 2010, FDA recommended suspending the use of Rotarix. After a careful evaluation of information from various sources, FDA has resumed the use of Rotarix and to continue the use of RotaTeq vaccines.
  To learn more, visit: FDA
• RotaTeq.  The U.S. Food and Drug Administration (FDA) licensed this vaccine (manufactured by Merck) in 2006.  To learn more, visit FDA.

Previously licensed rotavirus vaccine in the US:

• RotaShield. This vaccine was withdrawn from the market in 1999 because of an association with intussusception. To learn more, visit: Withdrawal of RotaShield Vaccine Recommendation.

More on Rotavirus Vaccine Safety

• Kawasaki Syndrome and RotaTeq Vaccine
• Monitoring of Intussusception after RotaTeq

Related Scientific Articles

Belongia EA, Irving SA, Shui IM, Kulldorff M, Lewis E, Yin R, Lieu TA, Weintraub E, Yih WK, Li R, Baggs J, Vaccine Safety Datalink Investigation Group. Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine. Pediatr Infect Dis J 2010;29(1), 1-5.

Centers for Disease Control and Prevention (CDC). Postlicensure monitoring of intussusception after RotaTeq Vaccination in the United States, February 1, 2006, to September 25, 2007. Pediatrics. 2008 Jun;121(6):1206-12.

Centers for Disease Control and Prevention (CDC). Intussusception among recipients of rotavirus vaccine—United States, 1998–1999. MMWR 1999;48(27):577–581.

Centers for Disease Control and Prevention (CDC). Withdrawal of rotavirus vaccine recommendation. MMWR 1999;48(43):1007.

Haber P, Patel M, Izurieta HS, Baggs J, Gargiullo P, Weintraub E, Cortese M, Braun MM, Belongia EA, Miller E, Ball R, Iskander J, Parashar UD. Postlicensure monitoring of intussusception and rotavirus vaccination in the United States, February 1, 2006, to September 25, 2007. Pediatrics 2008;121(6):1206-1212.

Patel MM, Haber P, Baggs J, Zuber P, Bines JE, Parashar UD. Intussusception and rotavirus vaccination: a review of the available evidence. Expert Rev Vaccines 2009;8(11):1555-1564.

Tate JE, Simonsen L, Viboud C, Steiner C, Patel MM, Curns AT, Parashar UD. Trends in intussusception hospitalizations among US infants, 1993-2004: implications for monitoring the safety of the new rotavirus vaccination program Pediatrics 2008;121(5):e1125-1132.