title: Potential intussusception risk versus benefits of rotavirus vaccination in the United States.
abstract: BACKGROUND
  International data show a low-level increased risk of intussusception associated with rotavirus vaccination. Although US data have not documented a risk, we assumed a risk similar to international settings and compared potential vaccine-associated intussusception cases with benefits of prevention of rotavirus gastroenteritis by a fully implemented US rotavirus vaccine program.
  
  
  METHODS
  To calculate excess intussusception cases, we used national data on vaccine coverage and baseline intussusception rates, and assumed a vaccine-associated intussusception relative risk of 5.3 (95% confidence interval [CI]: 3.0-9.3) in the first week after the first vaccine dose, the risk seen in international settings. We used postlicensure vaccine effectiveness data to calculate rotavirus disease burden averted.
  
  
  RESULTS
  For a US birth cohort of 4.3 million infants, vaccine-associated intussusception could cause an excess 0.2 (range: 0.1-0.3) deaths, 45 (range: 21-86) hospitalizations and 13 (range: 6-25) cases managed in short-stay or emergency department settings. Vaccination would avert 14 (95% CI: 10-19) rotavirus-associated deaths, 53,444 (95% CI: 37,622-72,882) hospitalizations and 169,949 (95% CI: 118,161-238,630) emergency department visits. Summary benefit-risk ratios for death and hospitalization are 71:1 and 1093:1, respectively.
  
  
  CONCLUSIONS
  The burden of severe rotavirus disease averted due to vaccination compared with the vaccine-associated intussusception events offers a side-by-side analysis of the benefits and potential risks. If an intussusception risk similar to that seen internationally exists in the United States, it is substantially exceeded by the benefits of rotavirus disease burden averted by vaccination.
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. rdesai1@cdc.gov
authors.forename: Rishi
authors.initials: R
authors.lastname: Desai
authors.forename: Margaret M
authors.initials: MM
authors.lastname: Cortese
authors.forename: Martin I
authors.initials: MI
authors.lastname: Meltzer
authors.forename: Manjunath
authors.initials: M
authors.lastname: Shankar
authors.forename: Jacqueline E
authors.initials: JE
authors.lastname: Tate
authors.forename: Catherine
authors.initials: C
authors.lastname: Yen
authors.forename: Manish M
authors.initials: MM
authors.lastname: Patel
authors.forename: Umesh D
authors.initials: UD
authors.lastname: Parashar
mesh_terms: D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007443:Intussusception / Q000453:epidemiology* / Q000276:immunology / Q000821:virology; D018448:Models, Immunological; D015233:Models, Statistical; D009010:Monte Carlo Method; D018570:Risk Assessment; D012400:Rotavirus Infections / Q000453:epidemiology* / Q000517:prevention & control; D022243:Rotavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D014481:United States / Q000453:epidemiology
chemical_list: D022243:Rotavirus Vaccines