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.
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: Guillermo M Ruiz-Palacios; Irene Pérez-Schael; F Raúl Velázquez; Hector Abate; Thomas Breuer; SueAnn Costa Clemens; Brigitte Cheuvart; Felix Espinoza; Paul Gillard; Bruce L Innis; Yolanda Cervantes; Alexandre C Linhares; Pío López; Mercedes Macías-Parra; Eduardo Ortega-Barría; Vesta Richardson; Doris Maribel Rivera-Medina; Luis Rivera; Belén Salinas; Noris Pavía-Ruz; Jorge Salmerón; Ricardo Rüttimann; Juan Carlos Tinoco; Pilar Rubio; Ernesto Nuñez; M Lourdes Guerrero; Juan Pablo Yarzábal; Silvia Damaso; Nadia Tornieporth; Xavier Sáez-Llorens; Rodrigo F Vergara; Timo Vesikari; Alain Bouckenooghe; Ralf Clemens; Béatrice De Vos; Miguel O'Ryan Journal: N Engl J Med Date: 2006-01-05 Impact factor: 91.245
Authors: Irene M Shui; James Baggs; Manish Patel; Umesh D Parashar; Melisa Rett; Edward A Belongia; Simon J Hambidge; Jason M Glanz; Nicola P Klein; Eric Weintraub Journal: JAMA Date: 2012-02-08 Impact factor: 56.272
Authors: Marc-Alain Widdowson; Martin I Meltzer; Xinzhi Zhang; Joseph S Bresee; Umesh D Parashar; Roger I Glass Journal: Pediatrics Date: 2007-04 Impact factor: 7.124
Authors: Jennifer E Cortes; Aaron T Curns; Jacqueline E Tate; Margaret M Cortese; Manish M Patel; Fangjun Zhou; Umesh D Parashar Journal: N Engl J Med Date: 2011-09-22 Impact factor: 91.245
Authors: Julie A Boom; Jacqueline E Tate; Leila C Sahni; Marcia A Rench; Jennifer J Hull; Jon R Gentsch; Manish M Patel; Carol J Baker; Umesh D Parashar Journal: Pediatrics Date: 2010-01-18 Impact factor: 7.124
Authors: Margaret M Cortese; Mary Allen Staat; Geoffrey A Weinberg; Kathryn Edwards; Marilyn A Rice; Peter G Szilagyi; Caroline B Hall; Daniel C Payne; Umesh D Parashar Journal: J Infect Dis Date: 2009-11-01 Impact factor: 5.226
Authors: Penina Haber; Manish Patel; Hector S Izurieta; James Baggs; Paul Gargiullo; Eric Weintraub; Margaret Cortese; M Miles Braun; Edward A Belongia; Elaine Miller; Robert Ball; John Iskander; Umesh D Parashar Journal: Pediatrics Date: 2008-06 Impact factor: 7.124
Authors: Mary Allen Staat; Daniel C Payne; Stephanie Donauer; Geoffrey A Weinberg; Kathryn M Edwards; Peter G Szilagyi; Marie R Griffin; Caroline B Hall; Aaron T Curns; Jon R Gentsch; Shelia Salisbury; Gerry Fairbrother; Umesh D Parashar Journal: Pediatrics Date: 2011-07-18 Impact factor: 7.124