The first evidence in this regard was provided by study results from Australia showing that over 6500 rotavirus-attributable diarrheal hospitalizations would be prevented annually, following vaccine introduction, compared with the 14 excess cases of intussusception that would occur in the same period. In one study involving Brazil and Mexico, a small transient increase in the intussusception risk was found within 7 days post first dose among Mexican infants, whereas in Brazil, a smaller risk was identified only after the second vaccine dose. In Mexico, 11,551 rotavirus-related hospitalizations and 663 deaths would be prevented by rotavirus vaccination annually compared with an estimated 41 excess intussusception cases and 2 deaths attributable to rotavirus vaccination. In Brazil, an estimated 69,572 hospitalizations and 640 deaths would be prevented compared with a predicted 55 excess intussusception cases and 3 deaths.
A large postmarketing surveillance study was con-ducted in Mexico, involving 1.5 million vaccinated infants, where the relative risk of intussusception during the 7 days after the first dose was comparable to the previous study, translating into 3 or 4 additional cases per 100,000 vaccinated infants.4
Since introduction of RotaTeq in the United States in 2006, several analyses have been performed to assess the risk of intussusception following rotavirus vaccination, based on multiple data sources and methodologies. An association was first established in 2013 when a self-controlled risk interval methodology was applied to VAERS reports for the period of 2006 to 2012. In this study, the estimated excess risk of intussusception following the first dose of RotaTeq was just 0.74 cases per 100,000 vaccinated infants.11
The current global evidence available on vaccination safety provides an indication that both licensed rotavirus vaccines are associated with a slight temporal increase in the risk for intussusception, primarily soon after the first dose, although of a substantially lower magnitude than that of Rotashield.
In a recent review of available safety data, the Global Advisory Committee on Vaccine Safety of WHO concluded that the benefits of rotavirus vaccines far outweigh the small risk of intussusception.9
Therefore, WHO holds the position that rotavirus vaccination should continue to be recommended for all countries’ NIPs. It is worth noting, however, that an estimated 62% of the world’s infants (~84 million) do not currently have access to this lifesaving vaccine because either their countries have not yet introduced rotavirus vaccines or they are not reached by current routine immunization strategies.
Dr. Linhares is head of the Virology Section of Instituto Evandro Chagas. He is credited with first detecting rotavirus in Brazil in 1976. He received his MD from the Federal University of Pará State in Brazil and his PhD in science from Fundação Oswaldo Cruz in Rio de Janeiro.
Dr. Justino is a medical researcher at the Virology Section of the Instituto Evandro Chagas. She is a pediatrician and received a MD and a MS in tropical diseases from the Federal University of Pará State, Brazil. She received a PhD in science from Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
- GBD Diarrhoeal Diseases Collaborators. Estimates of global, regional, and national morbidity, mortality, and aetiologies of diarrhoeal diseases: a systematic analysis of the Global Burden of Disease Study 2015 [published online June 1, 2017]. Lancet Infect Dis. 2017. doi: 10.1016/S1473-3099(17)30276-1.
- ROTA COUNCIL. Rotavirus: common, severe, devastating, preventable. 2016. Available from: http://rotacouncil.org/resources/rota-council-white-paper/. Accessed 15 June 2017.
- Tate JE, Burton AH, Boschi-Pinto C, Parashar UD; World Health Organization-Coordinated Global Rotavirus Surveillance Network. Global, regional, and national estimates of rotavirus mortality in children <5 years of age, 2000-2013. Clin Infect Dis. 2016;62(suppl 2):S96-S105. doi: 10.1093/cid/civ1013.
- Yen C, Healy K, Tate JE, et al. Rotavirus vaccination and intussusception – Science, surveillance, and safety: a review of evidence and recommendations for future priorities in low and middle income countries. Hum Vaccin Immunother. 2016;12(10):2580-2589. doi: 10.1080/21645515.2016.1197452.
- Gap analysis of rotavirus vaccine impact evaluations in settings of routine use. Johns Hopkins Bloomberg School of Public Health website. jhsph.edu/research/centers-and-institutes/ivac/resources/RVImpactGapAnalysis_FEB2017_FINAL_public.pdf. Accessed 15 June 2017.
- VIEW-hub Report: Global vaccine introduction and implementation, March 2017. Johns Hopkins Bloomberg School of Public Health website. jhsph.edu/research/centers-and-institutes/ivac/view-hub/ivac-view-hub-report-2017-march.pdf. Accessed 15 June 2017.
- Jonesteller CL, Burnett E, Yen C, Tate JE, Parashar UD. Effectiveness of rotavirus vaccination: A systematic review of the first decade of global post-licensure data, 2006-2016 [published online April 21, 2017]. Clin Infect Dis. 2017. doi: 10.1093/cid/cix369.
- Burnett E, Jonesteller CL, Tate JE, Yen C, Parashar UD. Global impact of rotavirus vaccination on childhood hospitalizations and mortality from diarrhea. J Infect Dis. 2017;215(11):1666-1672. doi: 10.1093/infdis/jix186.
- WHO. Rotavirus vaccines. WHO position paper – January 2013. Wkly Epidemiol Rec. 2013;88(5):49-64.
- World Health Organization. Update on intussusception following rotavirus vaccine administration. WHO website. who.int/vaccine_safety/committee/topics/rotavirus/rotarix_and_rotateq/dec_2013/en/. Published February 14, 2014. Accessed June 15, 2017.
- Haber P, Patel M, Pan Y, et al. Intussusception after rotavirus vaccines reported to US VAERS, 2006-2012. Pediatrics. 2013;131(6):1042-1049. doi: 10.1542/peds.2012-2554.