Key points
You can protect against rotavirus disease with vaccination.
Overview
Rotavirus is a contagious virus that can cause gastroenteritis (inflammation of the stomach and intestines).
The rotavirus vaccine is effective at preventing rotavirus disease.
Available vaccines & manufacturer package inserts
- The FDA approved Rotarix in 2008 for use in infants 6 to 24 weeks of age.
- The FDA approved RotaTeq in 2006 for use in infants 6 to 32 weeks of age
Keep Reading:
Rotavirus Vaccine Information Statement (VIS)
Who should & should not get the vaccine
Most babies who get rotavirus vaccine do not have any problems with it.
Keep Reading:
Who should & should not get the rotavirus vaccine?
Common side effects
- Irritability.
- Mild, temporary diarrhea or vomiting.
Some studies suggest that rotavirus vaccination possibly causes a small increase in the risk of intussusception, a type of bowel blockage. This side effect is very rare.
Vaccines, like any medicine, can have side effects. Most babies who get rotavirus vaccine do not have any problems with it.
Report possible adverse events to VAERS
The Vaccine Adverse Event Reporting System (VAERS) is an early warning system, co-managed by CDC and FDA, that monitors for potential vaccine safety problems. Healthcare providers and vaccine manufacturers are required by law to report certain adverse events (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) following vaccination to VAERS; patients and caregivers can also submit reports.
A closer look at the safety data
Studies from the United States and other countries show a small increased risk of intussusception following rotavirus vaccination. About 1 in 20,000 US infants to 1 in 100,000 US infants who get rotavirus vaccine might develop intussusception within a week of getting the vaccine. This means that between 40 and 120 U.S. infants might develop intussusception related to rotavirus vaccine each year.
How CDC monitors vaccine safety
CDC and the Food and Drug Administration (FDA) are committed to ensuring that vaccines provided to the public are safe and effective. Once vaccines are licensed or authorized for emergency use in the United States, CDC and FDA continuously monitor them through several safety systems.
Keep Reading:
About Vaccine Safety Programs
- Salmon DA, Lamber PH, Nohynek HM, Gee J, Parashar UD, Tate JE, Wilder-Smith A, Hartigan-Go KY, Smith PG, Zuber PLF. Novel vaccine safety issues and areas that would benefit from further researchBMJ Glob Health. 2021 May;6(Suppl 2):e003814. Epub ahead of print.
- Glanz JM, Clarke CL, Xu S, Daley MF, Shoup JA, Schroeder EB, Lewin BL, McClure DL, Kharbanda E, Klein NP, DeStefano F. Association between Rotavirus Vaccine and Type 1 Diabetes in Children.JAMA Pediatr. 2020 May 1;174(5):455-462. Epub 2020 Mar 9.
- Payne DC, Baggs J, Klein NP, Parashar UD. Does preventing rotavirus infections through vaccination also protect against naturally occurring intussusception over time?Clin Infect Dis. 2015 Jan 1;60(1):163-4.
- Tate JE, Curns AT, Cortese MM, Weintraub ES, Hambidge S, Zangwill KM, et al. Burden of acute gastroenteritis hospitalizations and emergency department visits in US children that is potentially preventable by rotavirus vaccination: A probe study using the now-withdrawn rotashield vaccine. Pediatrics. 2009;123(3):744-749.
- Clayton HA, Cortes MM, Payne DC, Bartlett DL, Zimmerman LA, Williams WG, et al. Rotavirus vaccination coverage and adherence to the Advisory Committee on Immunization Practices (ACIP)-recommended vaccination schedule–United States, February 2006-May 2007. MMWR. 2008;57(15):398-401.
- Chang EJ, Zangwill KM, Lee H, Ward JI. Lack of association between rotavirus infection and intussusception: Implications for use of attenuated rotavirus vaccines. Pediatr Infect Dis J. 2002;21(2):97-102.
- Kramarz P, France EK, DeStefano F, Black SB, Shinefield H, Ward JI, et al. Population-based study of rotavirus vaccination and intussusception. Pediatr Infect Dis J. 2001;20(4):410-416.
- Yen C, Jakob K, Hittier X, Gentsch J, LaRussa P, for the Clinical Immunization Safety Assessment (CISA) Network. Detection of fecal shedding of rotavirus vaccine in infants following their first dose of pentavalent rotavirus vaccine. Vaccine. 2011May 31;29(24):4151-5.
- Belongia, E. A., Irving, S. A., Shui, I. M., Kulldorff, M., Lewis, E., Yin, R., Lieu, T. A., Weintraub, E., Yih, W. K., Li, R., Baggs, J., & Vaccine Safety Datalink Investigation Group (2010). Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine. The Pediatric infectious disease journal, 29(1), 1–5. https://doi.org/10.1097/INF.0b013e3181af8605
- Buttery, J. P., Danchin, M. H., Lee, K. J., Carlin, J. B., McIntyre, P. B., Elliott, E. J., Booy, R., Bines, J. E., & PAEDS/APSU Study Group (2011). Intussusception following rotavirus vaccine administration: post-marketing surveillance in the National Immunization Program in Australia. Vaccine, 29(16), 3061–3066. https://doi.org/10.1016/j.vaccine.2011.01.088
- Carlin, J. B., Macartney, K. K., Lee, K. J., Quinn, H. E., Buttery, J., Lopert, R., Bines, J., & McIntyre, P. B. (2013). Intussusception risk and disease prevention associated with rotavirus vaccines in Australia's National Immunization Program. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 57(10), 1427–1434. https://doi.org/10.1093/cid/cit520
- Centers for Disease Control and Prevention. Addition of history of intussusception as a contraindication for rotavirus vaccination. MMWR. 2011 Oct 21;60(41):1427.
- Haber P, Patel M, Inzurieta HS, Baggs J, Gagiullo P, et al. 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.
- Haber P, Patel M, Pan Y, Baggs J, Haber M, et al. Intussusception after Rotavirus Vaccines—United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2012. Pediatrics. 2013 Jun;131(6):1042-9.
- Hibbs BF, Miller ER, Shimabukuro T. Notes from the field: Rotavirus vaccine administration errors- United States, 2006-2013. MMWR. 2014 Jan 31;63(4):81.
- Patel MM, Haber P, Baggs J, Zuber P, Bines JE, et al. Intussusception and rotavirus vaccination: A review of the available evidence.Expert Rev Vaccines. 2009;8(11):1555-1564.
- Patel MM, López-Collada VR, Bulhões MM, De Oliveira LH, Bautista Márquez A, et al. Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil.N Engl J Med. 2011 Jun 16;364(24):2283-92.
- Shui IM, Baggs J, Patel M, Parashar UD, Rett M, et al. Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants. JAMA. 2012 Feb 8;307(6):598-604.
- Tate JE, Simonsen L, Viboud C, Steiner C, Patel MM, et al. Trends in intussusception hospitalizations among US infants, 1993-2004: Implications for monitoring the safety of the new rotavirus vaccination program. Pediatrics. 2008 May;121(5):e1125-32.
- Weintraub ES, Baggs J, Duffy J, Vellozzi C, Belongia EA, et al. Risk of intussusception after monovalent rotavirus vaccination.N Engl J Med. 2014 Feb 6; 370(6):513-9.
- Yih WK, Lieu TA, Kulldorff M, Martin D, McMahill-Walraven CN, et al. Intussusception risk after rotavirus vaccination in U.S. infants. N Engl J Med. 2014 Feb 6;370(6):503-12.