Fifteen years of experience with the oral live-attenuated human rotavirus vaccine: reflections on lessons learned

References

• GBD 2016 Diarrhoeal Disease Collaborators. Estimates of the global, regional, and national morbidity, mortality, and aetiologies of diarrhoea in 195 countries: a systematic analysis for the global burden of disease study 2016. Lancet Infect Dis. 2018;18(11):1211–1228.
   PubMed Web of Science ®Google Scholar
• International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. Rota Council. Rotavirus disease and immunization: series of briefs. Cover of epidemiology and burden brief; 2019 cited 2019 Dec 30. Available from: http://rotacouncil.org/wp-content/uploads/2019/05/ROTA-Brief3-Burden-SP-1.pdf
   Google Scholar
• Pan American Health Organization (PAHO). About rotavirus; [ cited 2019 Dec 30]. Available from: http://www.paho.org/hq/index.php?option=com_content&view=article&id=1861:2009-about-rotavirus&Itemid=1621&lang=en
   Google Scholar
• Tate JE, Burton AH, Boschi-Pinto C, et al. 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.
   PubMed Web of Science ®Google Scholar
• Williams CJ, Lobanov A, Pebody RG. Estimated mortality and hospital admission due to rotavirus infection in the WHO European region. Epidemiol Infect. 2009;137(5):607–616.
   PubMed Web of Science ®Google Scholar
• Troeger C, Khalil IA, Rao PC, et al. Rotavirus vaccination and the global burden of rotavirus diarrhea among children younger than 5 years. JAMA Pediatr. 2018;172(10):958–965.
   PubMed Web of Science ®Google Scholar
• Rotavirus vaccines. WHO position paper - January 2013. Wkly Epidemiol Rec. 2013;88(5):49–64.
   PubMedGoogle Scholar
• GAVI. The vaccine alliance. Detailed product profiles. Rotavirus vaccines; 2020 cited 2020 May 5. Available from: http://www.gavi.org/library/gavi-documents/supply-procurement/detailed-product-profiles/
   Google Scholar
• Zhen SS, Li Y, Wang SM, et al. Effectiveness of the live attenuated rotavirus vaccine produced by a domestic manufacturer in China studied using a population-based case-control design. Emerg Microbes Infect. 2015;4(10):e64.
   PubMed Web of Science ®Google Scholar
• Dang DA, Nguyen VT, Vu DT, et al. A dose-escalation safety and immunogenicity study of a new live attenuated human rotavirus vaccine (Rotavin-M1) in Vietnamese children. Vaccine. 2012;30(Suppl 1):A114–121.
   PubMed Web of Science ®Google Scholar
• Bines JE, At Thobari J, Satria CD, et al. Human neonatal rotavirus vaccine (RV3-BB) to target rotavirus from birth. N Engl J Med. 2018;378(8):719–730.
   PubMed Web of Science ®Google Scholar
• O’Ryan M. Rotavirus vaccines: a story of success with challenges ahead. F1000Res. 2017;6:1517.
   PubMedGoogle Scholar
• Burke RM, Tate JE, Kirkwood CD, et al. Current and new rotavirus vaccines. Curr Opin Infect Dis. 2019;32(5):435–444.
   PubMed Web of Science ®Google Scholar
• Crawford SE, Ramani S, Tate JE, et al. Rotavirus infection. Nat Rev Dis Primers. 2017;3:17083.
   PubMed Web of Science ®Google Scholar
• Gentsch JR, Laird AR, Bielfelt B, et al. Serotype diversity and reassortment between human and animal rotavirus strains: implications for rotavirus vaccine programs. J Infect Dis. 2005;192(Suppl 1):S146–159.
   PubMed Web of Science ®Google Scholar
• Velazquez FR, Matson DO, Calva JJ, et al. Rotavirus infection in infants as protection against subsequent infections. N Engl J Med. 1996;335(14):1022–1028.
   PubMed Web of Science ®Google Scholar
• European Centre for Disease Prevention and Control. Expert opinion on rotavirus vaccination in infancy; 2017 cited 2019 Oct 14. Available from: https://ecdc.europa.eu/sites/portal/files/documents/rotavirus-vaccination-expert%20opinion-september-2017.pdf
   Google Scholar
• Bernstein DI. Live attenuated human rotavirus vaccine, Rotarix. Semin Pediatr Infect Dis. 2006;17(4):188–194.
   PubMedGoogle Scholar
• O’Ryan M. Rotarix (RIX4414): an oral human rotavirus vaccine. Expert Rev Vaccines. 2007;6(1):11–19.
   PubMed Web of Science ®Google Scholar
• Ward RL, Bernstein DI. Rotarix: a rotavirus vaccine for the world. Clin Infect Dis. 2009;48(2):222–228.
   PubMed Web of Science ®Google Scholar
• World Health Organization. WHO prequalified vaccines listing; [ updated 2019 May 30; cited 2019 Oct 14]. Available from: http://extranet.who.int/gavi/PQ_Web/
   Google Scholar
• Centers for Disease Control and Prevention. Suspension of rotavirus vaccine after reports of intussusception–United States, 1999. MMWR Morb Mortal Wkly Rep. 2004;53(34):786–789.
   PubMedGoogle Scholar
• Murphy TV, Gargiullo PM, Massoudi MS, et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med. 2001;344(8):564–572.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. RotaTeq SmPC 01/ 03/2016EMA EPAR update; 2016 cited 2019 Oct 14. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000669/WC500054185.pdf
   Google Scholar
• Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006;354(1):11–22.
   PubMed Web of Science ®Google Scholar
• Vesikari T, Matson DO, Dennehy P, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354(1):23–33.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Rotarix SmPC 31/ 03/2016EMA EPAR update; 2016 cited 2019 Oct 14. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000639/WC500054789.pdf
   Google Scholar
• Vesikari T, Karvonen A, Korhonen T, et al. Safety and immunogenicity of RIX4414 live attenuated human rotavirus vaccine in adults, toddlers and previously uninfected infants. Vaccine. 2004;22(21–22):2836–2842.
   PubMed Web of Science ®Google Scholar
• Soares-Weiser K, Maclehose H, Bergman H, et al. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev. 2012;11:CD008521.
   PubMed Web of Science ®Google Scholar
• Fathima P, Snelling TL, Gibbs RA. Effectiveness of rotavirus vaccines in an Australian population: A case-control study. Vaccine. 2019;37(41):6048–6053.
   PubMed Web of Science ®Google Scholar
• Maguire JE, Glasgow K, Glass K, et al. Rotavirus epidemiology and monovalent rotavirus vaccine effectiveness in Australia: 2010–2017. Pediatrics. 2019;144(4):e20191024.
   PubMed Web of Science ®Google Scholar
• International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. VIEW-hub RV- Vaccine introduction. Current dosing schedule; 2019. cited 2019 Oct 14. Available from: http://view-hub.org/viz/?YXBwaWQ9MSZpbmRpY2F0b3JpZD01NSZvdmVybGF5aWQ9NA==
   Google Scholar
• Perez Schael I, O’Ryan M, Sáez-Llorens X, et al. Clinical development, registration, and introduction of human rotavirus vaccine: the Latin American experience. Trials Vaccinol. 2012;1:10–20.
   Google Scholar
• Linhares AC, Velazquez FR, Perez-Schael I, et al. Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study. Lancet. 2008;371(9619):1181–1189.
   PubMed Web of Science ®Google Scholar
• Perez-Schael I, Salinas B, Tomat M, et al. Efficacy of the human rotavirus vaccine RIX4414 in malnourished children. J Infect Dis. 2007;196(4):537–540.
   PubMed Web of Science ®Google Scholar
• Salinas B, Perez Schael I, Linhares AC, et al. Evaluation of safety, immunogenicity and efficacy of an attenuated rotavirus vaccine, RIX4414: A randomized, placebo-controlled trial in Latin American infants. Pediatr Infect Dis J. 2005;24(9):807–816.
   PubMed Web of Science ®Google Scholar
• Tregnaghi MW, Abate HJ, Valencia A, et al. Human rotavirus vaccine is highly efficacious when coadministered with routine expanded program of immunization vaccines including oral poliovirus vaccine in Latin America. Pediatr Infect Dis J. 2011;30(6):e103–108.
   PubMed Web of Science ®Google Scholar
• O’Ryan M, Linhares AC. Update on Rotarix: an oral human rotavirus vaccine. Expert Rev Vaccines. 2009;8(12):1627–1641.
   PubMed Web of Science ®Google Scholar
• Kawamura N, Tokoeda Y, Oshima M, et al. Efficacy, safety and immunogenicity of RIX4414 in Japanese infants during the first two years of life. Vaccine. 2011;29(37):6335–6341.
   PubMed Web of Science ®Google Scholar
• Madhi SA, Kirsten M, Louw C, et al. Efficacy and immunogenicity of two or three dose rotavirus-vaccine regimen in South African children over two consecutive rotavirus-seasons: a randomized, double-blind, placebo-controlled trial. Vaccine. 2012;30(Suppl 1):A44–51.
   PubMed Web of Science ®Google Scholar
• Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007;370(9601):1757–1763.
   PubMed Web of Science ®Google Scholar
• Madhi SA, Cunliffe NA, Steele D, et al. Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med. 2010;362(4):289–298.
   PubMed Web of Science ®Google Scholar
• Phua KB, Lim FS, Lau YL, et al. Rotavirus vaccine RIX4414 efficacy sustained during the third year of life: a randomized clinical trial in an Asian population. Vaccine. 2012;30(30):4552–4557.
   PubMed Web of Science ®Google Scholar
• Li RC, Huang T, Li Y, et al. Human rotavirus vaccine (RIX4414) efficacy in the first two years of life: a randomized, placebo-controlled trial in China. Hum Vaccin Immunother. 2014;10(1):11–18.
   PubMed Web of Science ®Google Scholar
• Desselberger U. Differences of rotavirus vaccine effectiveness by country: likely causes and contributing factors. Pathogens. 2017;6(4):65.
   PubMed Web of Science ®Google Scholar
• Gruber JF, Becker-Dreps S, Hudgens MG, et al. Timing of rotavirus vaccine doses and severe rotavirus gastroenteritis among vaccinated infants in low- and middle-income countries. Epidemiology. 2018;29(6):867–875.
   PubMed Web of Science ®Google Scholar
• Burnett E, Lopman BA, Parashar UD. Potential for a booster dose of rotavirus vaccine to further reduce diarrhea mortality. Vaccine. 2017;35(51):7198–7203.
   PubMed Web of Science ®Google Scholar
• Dai X, Bai R, Jian M, et al. Immunogenicity of different dosing schedules of the human live attenuate rotavirus vaccine (RV1) in infants and children: a meta-analysis. Hum Vaccin Immunother. 2019;15(6):1228–1236.
   PubMed Web of Science ®Google Scholar
• Dennehy PH, Brady RC, Halperin SA, et al. Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine. Pediatr Infect Dis J. 2005;24(6):481–488.
   PubMed Web of Science ®Google Scholar
• Kompithra RZ, Paul A, Manoharan D, et al. Immunogenicity of a three dose and five dose oral human rotavirus vaccine (RIX4414) schedule in south Indian infants. Vaccine. 2014;32(Suppl 1):A129–133.
   PubMed Web of Science ®Google Scholar
• Lee B, Dickson DM, Alam M, et al. The effect of increased inoculum on oral rotavirus vaccine take among infants in Dhaka, Bangladesh: A double-blind, parallel group, randomized, controlled trial. Vaccine. 2020;38(1):90–99.
   PubMed Web of Science ®Google Scholar
• Plosker GL. Rotavirus vaccine RIX4414 (Rotarix): a pharmacoeconomic review of its use in the prevention of rotavirus gastroenteritis in developed countries. Pharmacoeconomics. 2011;29(5):439–454.
   PubMed Web of Science ®Google Scholar
• Karafillakis E, Hassounah S, Atchison C. Effectiveness and impact of rotavirus vaccines in Europe, 2006–2014. Vaccine. 2015;33(18):2097–2107.
   PubMed Web of Science ®Google Scholar
• Payne DC, Selvarangan R, Azimi PH, et al. Long-term consistency in rotavirus vaccine protection: RV5 and RV1 vaccine effectiveness in US children, 2012–2013. Clin Infect Dis. 2015;61(12):1792–1799.
   PubMed Web of Science ®Google Scholar
• Pindyck T, Tate JE, Parashar UD. A decade of experience with rotavirus vaccination in the United States - vaccine uptake, effectiveness, and impact. Expert Rev Vaccines. 2018;17(7):593–606.
   PubMed Web of Science ®Google Scholar
• Willame C, Vonk Noordegraaf-Schouten M, Gvozdenovic E, et al. Effectiveness of the oral human attenuated rotavirus vaccine: A systematic review and meta-analysis-2006–2016. Open Forum Infect Dis. 2018;5(11):ofy292.
   PubMed Web of Science ®Google Scholar
• Paternina-Caicedo A, Parashar UD, Alvis-Guzman N, et al. Effect of rotavirus vaccine on childhood diarrhea mortality in five Latin American countries. Vaccine. 2015;33(32):3923–3928.
   PubMed Web of Science ®Google Scholar
• Richardson V, Parashar U, Patel M. Childhood diarrhea deaths after rotavirus vaccination in Mexico. N Engl J Med. 2011;365(8):772–773.
   PubMed Web of Science ®Google Scholar
• Gastanaduy PA, Sanchez-Uribe E, Esparza-Aguilar M, et al. Effect of rotavirus vaccine on diarrhea mortality in different socioeconomic regions of Mexico. Pediatrics. 2013;131(4):e1115–1120.
   PubMed Web of Science ®Google Scholar
• Bayard V, DeAntonio R, Contreras R, et al. Impact of rotavirus vaccination on childhood gastroenteritis-related mortality and hospital discharges in Panama. Int J Infect Dis. 2012;16(2):e94–98.
   PubMed Web of Science ®Google Scholar
• Leshem E, Tate JE, Steiner CA, et al. Acute gastroenteritis hospitalizations among US children following implementation of the rotavirus vaccine. JAMA. 2015;313(22):2282–2284.
   PubMed Web of Science ®Google Scholar
• Uhlig U, Kostev K, Schuster V, et al. Impact of rotavirus vaccination in Germany: rotavirus surveillance, hospitalization, side effects and comparison of vaccines. Pediatr Infect Dis J. 2014;33(11):e299–304.
   PubMed Web of Science ®Google Scholar
• Doll MK, Buckeridge DL, Morrison KT, et al. Effectiveness of monovalent rotavirus vaccine in a high-income, predominant-use setting. Vaccine. 2015;33(51):7307–7314.
   PubMed Web of Science ®Google Scholar
• Standaert B, Gomez JA, Raes M, et al. Impact of rotavirus vaccination on hospitalisations in Belgium: comparing model predictions with observed data. PLoS One. 2013;8(1):e53864.
   PubMed Web of Science ®Google Scholar
• Araki K, Hara M, Tsugawa T, et al. Effectiveness of monovalent and pentavalent rotavirus vaccines in Japanese children. Vaccine. 2018;36(34):5187–5193.
   PubMed Web of Science ®Google Scholar
• Sahakyan G, Grigoryan S, Wasley A, et al. Impact and effectiveness of monovalent rotavirus vaccine in Armenian children. Clin Infect Dis. 2016;62(Suppl 2):S147–154.
   PubMed Web of Science ®Google Scholar
• Atchison CJ, Stowe J, Andrews N, et al. Rapid declines in age group-specific rotavirus infection and acute gastroenteritis among vaccinated and unvaccinated individuals within 1 year of rotavirus vaccine introduction in England and Wales. J Infect Dis. 2016;213(2):243–249.
   PubMed Web of Science ®Google Scholar
• Inns T, Trindall A, Dunling-Hall S, et al. Introduction of a new rotavirus vaccine: initial results of uptake and impact on laboratory confirmed cases in Anglia and Essex, United Kingdom, July 2015. Hum Vaccin Immunother. 2016;12(4):1040–1044.
   PubMed Web of Science ®Google Scholar
• Gheorghita S, Birca L, Donos A, et al. Impact of rotavirus vaccine introduction and vaccine effectiveness in the Republic of Moldova. Clin Infect Dis. 2016;62(Suppl 2):S140–146.
   PubMed Web of Science ®Google Scholar
• Yen C, Armero Guardado JA, Alberto P, et al. Decline in rotavirus hospitalizations and health care visits for childhood diarrhea following rotavirus vaccination in El Salvador. Pediatr Infect Dis J. 2011;30(1 Suppl):S6–S10.
   PubMed Web of Science ®Google Scholar
• Bar-Zeev N, Jere KC, Bennett A, et al. Population impact and effectiveness of monovalent rotavirus vaccination in urban Malawian children 3 years after vaccine introduction: ecological and case-control analyses. Clin Infect Dis. 2016;62(Suppl 2):S213–219.
   PubMed Web of Science ®Google Scholar
• Pendleton A, Galic M, Clarke C, et al. Impact of rotavirus vaccination in Australian children below 5 years of age: a database study. Hum Vaccin Immunother. 2013;9(8):1617–1625.
   PubMed Web of Science ®Google Scholar
• Msimang VM, Page N, Groome MJ, et al. Impact of rotavirus vaccine on childhood diarrheal hospitalization after introduction into the South African public immunization program. Pediatr Infect Dis J. 2013;32(12):1359–1364.
   PubMed Web of Science ®Google Scholar
• Safadi MA, Berezin EN, Munford V, et al. Hospital-based surveillance to evaluate the impact of rotavirus vaccination in Sao Paulo, Brazil. Pediatr Infect Dis J. 2010;29(11):1019–1022.
   PubMed Web of Science ®Google Scholar
• Jonesteller CL, Burnett E, Yen C, et al. Effectiveness of rotavirus vaccination: A systematic review of the first decade of global postlicensure data, 2006–2016. Clin Infect Dis. 2017;65(5):840–850.
   PubMed Web of Science ®Google Scholar
• Mwenda JM, Parashar UD, Cohen AL, et al. Impact of rotavirus vaccines in Sub-Saharan African countries. Vaccine. 2018;36(47):7119–7123.
   PubMedGoogle Scholar
• Bar-Zeev N, King C, Phiri T, et al. Impact of monovalent rotavirus vaccine on diarrhoea-associated post-neonatal infant mortality in rural communities in Malawi: a population-based birth cohort study. Lancet Glob Health. 2018;6(9):e1036–e1044.
   PubMed Web of Science ®Google Scholar
• Armah G, Pringle K, Enweronu-Laryea CC, et al. Impact and effectiveness of monovalent rotavirus vaccine against severe rotavirus diarrhea in Ghana. Clin Infect Dis. 2016;62(Suppl 2):S200–207.
   PubMed Web of Science ®Google Scholar
• Beres LK, Tate JE, Njobvu L, et al. A preliminary assessment of rotavirus vaccine effectiveness in Zambia. Clin Infect Dis. 2016;62(Suppl 2):S175–182.
   PubMed Web of Science ®Google Scholar
• Shah MP, Tate JE, Mwenda JM, et al. Estimated reductions in hospitalizations and deaths from childhood diarrhea following implementation of rotavirus vaccination in Africa. Expert Rev Vaccines. 2017;16(10):987–995.
   PubMed Web of Science ®Google Scholar
• Raes M, Strens D, Vergison A, et al. Reduction in pediatric rotavirus-related hospitalizations after universal rotavirus vaccination in Belgium. Pediatr Infect Dis J. 2011;30(7):e120–125.
   PubMed Web of Science ®Google Scholar
• Standaert B, Strens D, Alwan A, et al. Medium- to long-term impact of rotavirus vaccination on hospital care in Belgium: A 7-year follow-up of the Rotavirus Belgium Impact Study (RotaBIS). Infect Dis Ther. 2016;5(1):31–44.
   PubMed Web of Science ®Google Scholar
• Public Health England. Health protection report; 2016. cited 2019 Dec 30. Available from: http://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/555048/hpr3216_rtvrs_VC.pdf
   Google Scholar
• Thomas SL, Walker JL, Fenty J, et al. Impact of the national rotavirus vaccination programme on acute gastroenteritis in England and associated costs averted. Vaccine. 2017;35(4):680–686.
   PubMed Web of Science ®Google Scholar
• Hungerford D, Vivancos R, Read JM, et al. Rotavirus vaccine impact and socioeconomic deprivation: an interrupted time-series analysis of gastrointestinal disease outcomes across primary and secondary care in the UK. BMC Med. 2018;16(1):10.
   PubMed Web of Science ®Google Scholar
• Walker JL, Andrews NJ, Atchison CJ, et al. Effectiveness of oral rotavirus vaccination in England against rotavirus-confirmed and all-cause acute gastroenteritis. Vaccine X. 2019;1:100005.
   PubMedGoogle Scholar
• Jit M, Edmunds WJ. Evaluating rotavirus vaccination in England and Wales. Part II. The potential cost-effectiveness of vaccination. Vaccine. 2007;25(20):3971–3979.
   PubMed Web of Science ®Google Scholar
• WHO. Global advisory committee on vaccine safety, 11–12 December 2013. Wkly Epidemiol Rec. 2014;89(7):53–60.
   Google Scholar
• Rosillon D, Buyse H, Friedland LR, et al. Risk of intussusception after rotavirus vaccination: meta-analysis of postlicensure studies. Pediatr Infect Dis J. 2015;34(7):763–768.
   PubMed Web of Science ®Google Scholar
• Tate JE, Mwenda JM, Armah G, et al. Evaluation of intussusception after monovalent rotavirus vaccination in Africa. N Engl J Med. 2018;378(16):1521–1528.
   PubMed Web of Science ®Google Scholar
• Burke RM, Tate JE, Dahl RM, et al. Does rotavirus vaccination affect longer-term intussusception risk in US infants? J Pediatric Infect Dis Soc. 2020;9(2):257–260.
   PubMed Web of Science ®Google Scholar
• Hawken S, Ducharme R, Rosella LC, et al. Assessing the risk of intussusception and rotavirus vaccine safety in Canada. Hum Vaccin Immunother. 2017;13(3):703–710.
   PubMed Web of Science ®Google Scholar
• WHO. Global advisory committee on vaccine safety, 6–7 December 2017. Wkly Epidemiol Rec. 2018;93(2):17–30.
   Google Scholar
• Cunliffe N, Zaman K, Rodrigo C, et al. Early exposure of infants to natural rotavirus infection: a review of studies with human rotavirus vaccine RIX4414. BMC Pediatr. 2014;14:295.
   PubMed Web of Science ®Google Scholar
• Patel MM, Clark AD, Sanderson CFB, et al. Removing the age restrictions for rotavirus vaccination: a benefit-risk modeling analysis. PLoS Med. 2012;9(10):e1001330.
   PubMed Web of Science ®Google Scholar
• Steele AD, Madhi SA, Cunliffe NA, et al. Incidence of rotavirus gastroenteritis by age in African, Asian and European children: relevance for timing of rotavirus vaccination. Hum Vaccin Immunother. 2016;12(9):2406–2412.
   PubMed Web of Science ®Google Scholar
• Yung CF, Chong CY, Thoon KC. Age at first rotavirus vaccination and risk of intussusception in infants: A public health modeling analysis. Drug Saf. 2016;39(8):745–748.
   PubMed Web of Science ®Google Scholar
• Koch J, Harder T, von Kries R, et al. Risk of intussusception after rotavirus vaccination. Dtsch Arztebl Int. 2017;114(15):255–262.
   PubMed Web of Science ®Google Scholar
• Krishnarajah G, Davis EJ, Fan Y, et al. Rotavirus vaccine series completion and adherence to vaccination schedules among infants in managed care in the United States. Vaccine. 2012;30(24):3717–3722.
   PubMed Web of Science ®Google Scholar
• Krishnarajah G, Landsman-Blumberg P, Eynullayeva E. Rotavirus vaccination compliance and completion in a Medicaid infant population. Vaccine. 2015;33(3):479–486.
   PubMed Web of Science ®Google Scholar
• Marti SG, Alcaraz A, Valanzasca P, et al. Cost effectiveness evaluation of a rotavirus vaccination program in Argentina. Vaccine. 2015;33(42):5684–5690.
   PubMed Web of Science ®Google Scholar
• Luna-Casas G, Juliao P, Carreno-Manjarrez R, et al. Vaccine coverage and compliance in Mexico with the two-dose and three-dose rotavirus vaccines. Hum Vaccin Immunother. 2019;15(6):1251–1259.
   PubMed Web of Science ®Google Scholar
• Banyai K, Estes MK, Martella V, et al. Viral gastroenteritis. Lancet. 2018;392(10142):175–186.
   PubMed Web of Science ®Google Scholar
• EuroRotaNet. Annual report 2018; 2019 [cited 2020 May Oct 6]. Available from: http://www.eurorotanet.com/wp-content/uploads/2019/09/EuroRotaNet_report-Sept_2019_v1.pdf
   Google Scholar
• Roczo-Farkas S, Kirkwood CD, Bines JE. Australian rotavirus surveillance program annual report, 2015. Commun Dis Intell Q Rep. 2016;40(4):E527–E538.
   PubMed Web of Science ®Google Scholar
• Roczo-Farkas S, Kirkwood CD, Cowley D, et al. The impact of rotavirus vaccines on genotype diversity: A comprehensive analysis of 2 decades of Australian surveillance data. J Infect Dis. 2018;218(4):546–554.
   PubMed Web of Science ®Google Scholar
• Carvalho-Costa FA, de Assis RMS, Fialho AM, et al. The evolving epidemiology of rotavirus A infection in Brazil a decade after the introduction of universal vaccination with Rotarix. BMC Pediatr. 2019;19(1):42.
   PubMed Web of Science ®Google Scholar
• Paulke-Korinek M, Kundi M, Rendi-Wagner P, et al. Herd immunity after two years of the universal mass vaccination program against rotavirus gastroenteritis in Austria. Vaccine. 2011;29(15):2791–2796.
   PubMed Web of Science ®Google Scholar
• Baker JM, Tate JE, Steiner CA, et al. Longer-term direct and indirect effects of infant rotavirus vaccination across all ages in the United States in 2000–2013: analysis of a large hospital discharge dataset. Clin Infect Dis. 2018;68(6):976–983.
   Web of Science ®Google Scholar
• Gervasi G, Capanna A, Mita V, et al. Nosocomial rotavirus infection: an up to date evaluation of European studies. Hum Vaccin Immunother. 2016;12(9):2413–2418.
   PubMed Web of Science ®Google Scholar
• Gleizes O, Desselberger U, Tatochenko V, et al. Nosocomial rotavirus infection in European countries: a review of the epidemiology, severity and economic burden of hospital-acquired rotavirus disease. Pediatr Infect Dis J. 2006;25(1 Suppl):S12–21.
   PubMed Web of Science ®Google Scholar
• Standaert B, Strens D, Li X, et al. The sustained rotavirus vaccination impact on nosocomial infection, duration of hospital stay, and age: the RotaBIS study (2005–2012). Infect Dis Ther. 2016;5(4):509–524.
   PubMed Web of Science ®Google Scholar
• Zlamy M, Kofler S, Orth D, et al. The impact of rotavirus mass vaccination on hospitalization rates, nosocomial rotavirus gastroenteritis and secondary blood stream infections. BMC Infect Dis. 2013;13:112.
   PubMed Web of Science ®Google Scholar
• Pardo-Seco J, Cebey-Lopez M, Martinon-Torres N, et al. Impact of rotavirus vaccination on childhood hospitalization for seizures. Pediatr Infect Dis J. 2015;34(7):769–773.
   PubMed Web of Science ®Google Scholar
• Biggart R, Finn A, Marlow R. Lack of impact of rotavirus vaccination on childhood seizure hospitalizations in England - An interrupted time series analysis. Vaccine. 2018;36(31):4589–4592.
   PubMed Web of Science ®Google Scholar
• Hungerford DJ, French N, Iturriza-Gomara M, et al. Reduction in hospitalisations for acute gastroenteritis-associated childhood seizures since introduction of rotavirus vaccination: a time-series and change-point analysis of hospital admissions in England. J Epidemiol Community Health. 2019;73(11):1020–1025.
   PubMed Web of Science ®Google Scholar
• Checkley W, Buckley G, Gilman RH, et al. Multi-country analysis of the effects of diarrhoea on childhood stunting. Int J Epidemiol. 2008;37(4):816–830.
   PubMed Web of Science ®Google Scholar
• Walker SP, Wachs TD, Grantham-McGregor S, et al. Inequality in early childhood: risk and protective factors for early child development. Lancet. 2011;378(9799):1325–1338.
   PubMed Web of Science ®Google Scholar
• Lorntz B, Soares AM, Moore SR, et al. Early childhood diarrhea predicts impaired school performance. Pediatr Infect Dis J. 2006;25(6):513–520.
   PubMed Web of Science ®Google Scholar
• Van der Wielen M, Giaquinto C, Gothefors L, et al. Impact of community-acquired paediatric rotavirus gastroenteritis on family life: data from the REVEAL study. BMC Fam Pract. 2010;11:22.
   PubMed Web of Science ®Google Scholar
• Standaert B, Van de Mieroop E, Nelen V. Exploring the potential impact of rotavirus vaccination on work absenteeism among female administrative personnel of the City of Antwerp through a retrospective database analysis. BMJ Open. 2015;5(6):e007453.
   PubMed Web of Science ®Google Scholar
• Poulos C, Standaert B, Sloesen B, et al. Preferences for vaccines against children’s diarrheal illness among mothers in Poland and Hungary. Vaccine. 2018;36(40):6022–6029.
   PubMed Web of Science ®Google Scholar
• Standaert B, Alwan A, Strens D, et al. Improvement in hospital quality of care (QoC) after the introduction of rotavirus vaccination: an evaluation study in Belgium. Hum Vaccin Immunother. 2015;11(9):2266–2273.
   PubMed Web of Science ®Google Scholar
• Heinsbroek E, Hungerford D, Cooke RPD, et al. Do hospital pressures change following rotavirus vaccine introduction? A retrospective database analysis in a large paediatric hospital in the UK. BMJ Open. 2019;9(5):e027739.
   PubMed Web of Science ®Google Scholar
• International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health, Rota Council. The economic burden; 2017 [cited 2019 Oct 14]. Available from: http://rotacouncil.org/rotavirus-disease/global-burden/
   Google Scholar
• Standaert B, Harlin O, Desselberger U. The financial burden of rotavirus disease in four countries of the European Union. Pediatr Infect Dis J. 2008;27(1):S20–S27.
   Web of Science ®Google Scholar
• Sigei C, Odaga J, Mvundura M, et al. Cost-effectiveness of rotavirus vaccination in Kenya and Uganda. Vaccine. 2015;33(Suppl 1):A109–118.
   PubMed Web of Science ®Google Scholar
• International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. Technical information for national-level rotavirus vaccine policy recommendations. Summary of available evidence to guide decision-making; 2017 [cited 2019 Oct 14]. Available from: http://www.jhsph.edu/ivac/wp-content/uploads/2018/05/RVVTechnicalBriefings-Jan2017.pdf
   Google Scholar
• Chai PF, Lee WS. Out-of-pocket costs associated with rotavirus gastroenteritis requiring hospitalization in Malaysia. Vaccine. 2009;27(Suppl 5):F112–115.
   PubMed Web of Science ®Google Scholar
• Plosker GL. Pharmacoeconomic spotlight on rotavirus vaccine RIX4414 (Rotarix) in the prevention of rotavirus gastroenteritis in developing countries. Paediatr Drugs. 2012;14(6):429–433.
   PubMedGoogle Scholar
• Thomson A, Robinson K, Vallee-Tourangeau G. The 5As: A practical taxonomy for the determinants of vaccine uptake. Vaccine. 2016;34(8):1018–1024.
   PubMed Web of Science ®Google Scholar
• International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. VIEW-hub; [ cited 2020 May 27]. Available from: www.view-hub.org
   Google Scholar
• Poelaert D, Pereira P, Gardner R, et al. A review of recommendations for rotavirus vaccination in Europe: arguments for change. Vaccine. 2018;36(17):2243–2253.
   PubMed Web of Science ®Google Scholar
• Kotsopoulos N, Haitsma G, Connolly MP, et al. Estimating the money flow in the economy attributed to rotavirus disease and vaccination in the Netherlands using a Social Accounting Matrix (SAM) framework. Expert Rev Pharmacoecon Outcomes Res. 2019;1–10.
   PubMed Web of Science ®Google Scholar
• Sedita J, Perrella S, Morio M, et al. Cost of goods sold and total cost of delivery for oral and parenteral vaccine packaging formats. Vaccine. 2018;36(12):1700–1709.
   PubMed Web of Science ®Google Scholar
• Kilich E, Sadarangani M. Use of rotavirus vaccines in preterm babies on the neonatal unit. Expert Rev Vaccines. 2016;15(12):1463–1465.
   PubMed Web of Science ®Google Scholar
• Bruijning-Verhagen P, Mangen MJJ, Felderhof M, et al. Targeted rotavirus vaccination of high-risk infants; a low cost and highly cost-effective alternative to universal vaccination. BMC Med. 2013;11:112.
   PubMed Web of Science ®Google Scholar
• Stumpf KA, Thompson T, Sanchez PJ. Rotavirus vaccination of very low birth weight infants at discharge from the NICU. Pediatrics. 2013;132(3):e662–665.
   PubMed Web of Science ®Google Scholar
• Jaques SC, Ogley L, Duffy D, et al. Rotavirus immunisation in NICU: a 1-year experience in a UK tertiary neonatal surgical unit postvaccine introduction. Arch Dis Child Fetal Neonatal Ed. 2015;100(2):F186–187.
   PubMed Web of Science ®Google Scholar
• Omenaca F, Sarlangue J, Szenborn L, et al. Safety, reactogenicity and immunogenicity of the human rotavirus vaccine in preterm European Infants: a randomized phase IIIb study. Pediatr Infect Dis J. 2012;31(5):487–493.
   PubMed Web of Science ®Google Scholar
• Hemming-Harlo M, Lahdeaho ML, Maki M, et al. Rotavirus vaccination does not Increase type 1 diabetes and may decrease celiac disease in children and adolescents. Pediatr Infect Dis J. 2019;38(5):539–541.
   PubMed Web of Science ®Google Scholar
• Perrett KP, Jachno K, Nolan TM, et al. Association of rotavirus vaccination with the incidence of type 1 diabetes in children. JAMA Pediatr. 2019;173(3):280–282; Erratum in JAMA Pediatr. 2019;2173(2019):2895.
   PubMed Web of Science ®Google Scholar
• Changotra H, Vij A. Rotavirus virus-like particles (RV-VLPs) vaccines: an update. Rev Med Virol. 2017;27(6):e1954.
   Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Addition of severe combined immunodeficiency as a contraindication for administration of rotavirus vaccine. MMWR Morb Mortal Wkly Rep. 2010;59(22):687–688.
   PubMedGoogle Scholar