Rotarix^®: vaccine performance 6 years postlicensure

References

• O’Ryan M, Linhares AC. Update on rotarix: an oral human rotavirus vaccine. Expert Rev. Vaccines8(12), 1627–1641 (2009).
   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. Lancet370, 1757–1763 (2007).
   PubMed Web of Science ®Google Scholar
• Phua KB, Lim FS, Lau YL et al. Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: randomised, double-blind, controlled study. Vaccine27, 5936–5941 (2009).
   PubMed Web of Science ®Google Scholar
• Linhares AC, Velázquez FR, Pérez-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 3 study. Lancet371, 1181–1189 (2008).
   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.30, e103–e108 (2011).
   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.362, 289–298 (2010).
   PubMed Web of Science ®Google Scholar
• Steele AD, Madhi SA, Louw CE et al. Safety, reactogenicity, and immunogenicity of human rotavirus vaccine RIX4414 in human immunodeficiency virus-positive infants in South Africa. Pediatr. Infect. Dis. J.30, 25–30 (2011).
   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. Vaccine29, 6335– 6341 (2011).
   PubMed Web of Science ®Google Scholar
• World Health Organization. Meeting of the immunization strategic advisory group of experts, April 2009 – conclusions and recommendations. Wkly Epidemiol. Rec.84, 13–236 (2009).
   Google Scholar
• Parry J. New vaccines to boost child care in developing countries. World Health Organ.85, 426–427 (2007).
   PubMed Web of Science ®Google Scholar
• You D, Wardlaw T, Salama P, Jones G. Levels and trends in under-5 mortality, 1990–2008. Lancet375, 100–103 (2010).
   PubMed Web of Science ®Google Scholar
• Patel MM, Steele, D, Gentsch JR et al. Real-world impact of rotavirus vaccination. Pediatr. Infect. Dis. J.30(Suppl. 1), S1–S5 (2011).
   PubMed Web of Science ®Google Scholar
• de Oliveira LH, Donovaro-Holliday MC, Mattus CR, Andrus JK. Rotavirus vaccine introduction in the Americas: progress and lessons learned. Expert Rev. Vaccines7, 345–353 (2008).
   PubMed Web of Science ®Google Scholar
• Tate JE, Patel MM, Steele AD et al. Global impact of rotavirus vaccines. Expert Rev. Vaccines9, 395–407 (2010).
   PubMed Web of Science ®Google Scholar
• Usher AD. GAVI takes steps to address funding woes. Lancet377, 453 (2011).
   PubMed Web of Science ®Google Scholar
• Patel MM, Parashar UD. Assessing the effectiveness and public health impact of rotavirus vaccines after introduction in immunization programs. J. Infect. Dis.200(Suppl. 1), S291–S299 (2009).
   PubMed Web of Science ®Google Scholar
• Patel MM, López-Collada VR, Bulhões MM et al. Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil. N. Engl. J. Med.364, 2283–2292 (2011).
   PubMed Web of Science ®Google Scholar
• de Palma O, Cruz L, Ramos H et al. Effectiveness of rotavirus vaccination against childhood diarrhoea in El Salvador: case–control study. BMJ340, c2825 (2010).
   PubMed Web of Science ®Google Scholar
• Correia JB, Patel MM, Nakagomi O et al. Effectiveness of monovalent rotavirus vaccine (Rotarix) against severe diarrhoea caused by serotypically-unrelated G2P[4] strains in Brazil. J. Infect. Dis.201, 363–369 (2010).
   PubMed Web of Science ®Google Scholar
• Justino MCA, Linhares AC, Lanzieri R et al. Effectiveness of the monovalent G1P[8] human rotavirus vaccine against hospitalization for severe G2P[4] rotavirus gastroenteritis in Belém, Brazil. Pediatr. Infect. Dis. J.30, 396–401 (2011).
   PubMed Web of Science ®Google Scholar
• Snelling TL, Schultz R, Graham J et al. Rotavirus and the indigenous children of the Australian outback: monovalent vaccine effective in a high-burden setting. CID49, 428–431 (2009).
   PubMed Web of Science ®Google Scholar
• Snelling TL, Andrews RM, Kirkwood CM et al. Case–control evaluation of the effectiveness of the G1P[8] human rotavirus vaccine during an outbreak of rotavirus G2P[4] infection in Central Australia. CID52, 191–199 (2011).
   PubMed Web of Science ®Google Scholar
• Zeller M, Rahman M, Heylen E et al. Rotavirus incidence and genotype distribution before and after national rotavirus vaccine introduction in Belgium. Vaccine28, 7507–7513 (2010).
   PubMed Web of Science ®Google Scholar
• Braeckman T, Van Herck K, Raes M et al. Rotavirus vaccines in Belgium: policy and impact. Pediatr. Infect. Dis. J.30(Suppl. 1), S21–S24 (2011).
   PubMed Web of Science ®Google Scholar
• Paulke-Korinek M, Rendi-Wagner P, Kundi M, Kronik R, Kollaritsch H. Universal mass vaccination against rotavirus gastroenteritis: impact on hospitalization rates in Austrian children. Pediatr. Infect. Dis. J.29, 319–323 (2010).
   PubMed Web of Science ®Google Scholar
• Buttery JP, Lambert SB, Grimwood K et al. Reduction in rotavirus-associated acute gastroenteritis following introduction of rotavirus vaccine into Australia’s national childhood vaccine schedule. Pediatr. Infect. Dis. J.30(Suppl. 1), S25–S29 (2011).
   PubMed Web of Science ®Google Scholar
• Macartney KK, Porwal M, Dalton D et al. Decline in rotavirus hospitalisations following introduction of Australia’s national rotavirus immunisation programme. J. Paediatr. Child Health47, 266–270 (2011).
   PubMed Web of Science ®Google Scholar
• Molto Y, Cortes JE, De Oliveira LH et al. Reduction of diarrhea-associated hospitalizations among children aged < 5 years in Panama following the introduction of rotavirus vaccine. Pediatr. Infect. Dis. J.30(Suppl. 1), S16–S20 (2011).
   PubMed Web of Science ®Google Scholar
• Quintanar-Solares M, Yen C, Richardson V et al. Impact of rotavirus vaccination on diarrhea-related hospitalizations among children <5 years of age in Mexico. Pediatr. Infect. Dis. J.30(Suppl. 1), S11–S15 (2011).
   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.30(Suppl. 1), S6–S10 (2011).
   PubMed Web of Science ®Google Scholar
• Gurgel RQ, Bohland AN, Vieira SA et al. Incidence of rotavirus and all-cause diarrhea in northeast Brazil following the introduction of a national vaccination program. Gastroenterology137, 1970–1975 (2009).
   PubMed Web of Science ®Google Scholar
• Sáfadi MA, Berezin EN, Munford V et al. Hospital-based surveillance to evaluate the impact of rotavirus vaccination in São Paulo, Brazil. Pediatr. Infect. Dis. J.29, 1019–1022 (2010).
   PubMed Web of Science ®Google Scholar
• Lanzieri T, Costa I, Shafi F et al. Trends in hospitalizations from all-cause gastroenteritis in children younger than 5 years of age in Brazil before and after human rotavirus vaccine introduction, 1998–2007. Pediatr. Infect. Dis. J.29, 673–675 (2010).
   PubMed Web of Science ®Google Scholar
• do Carmo GM, Yen C, Cortes J et al. Decline in diarrhea mortality and admissions after routine childhood rotavirus immunization in Brazil: a time-series analysis. PLoS Med.8, e1001024 (2011).
   PubMed Web of Science ®Google Scholar
• Richardson V, Hernandez-Pichardo J, Quintanar-Solares M et al. Effect of rotavirus vaccination on death from childhood diarrhea in Mexico. N. Engl. J. Med.362, 299–305 (2010).
   PubMed Web of Science ®Google Scholar
• Lanzieri TM, Linhares AC, Costa I et al. Impact of rotavirus vaccination on childhood deaths from diarrhea in Brazil. Int. J. Infect. Dis.15, e206–e210 (2011).
   PubMed Web of Science ®Google Scholar
• Murphy TV, Gargiullo PM, Massoudi MS et al. Intussusception among infants given an oral rotavirus vaccine. N. Engl. J. Med.344, 564–572 (2001).
   PubMed Web of Science ®Google Scholar
• Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N. Engl. J. Med.354, 11–22 (2006).
   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.354, 23–33 (2006).
   PubMed Web of Science ®Google Scholar
• Macias M. The rotavirus vaccine RIX 4414 (Rotarix™) is not associated with intussusception in one year old infants. ICAAC, Washington, DC, USA (2005).
   Google Scholar
• Greenberg HB. Rotavirus vaccination and intussusceptions – act two. N. Engl. J. Med.364, 2354–2355 (2011).
   PubMed Web of Science ®Google Scholar
• Buttery JP, Danchin MH, Lee KJ et al. Intussusception following rotavirus vaccine administration: post-marketing surveillance in the national immunization program in Australia. Vaccine29, 3061–3066 (2011).
   PubMed Web of Science ®Google Scholar
• Velazquez R. PP106. Special issue: abstracts from the 2nd excellence in paediatrics conference, 2–4 Dec 2010, London, UK. Acta Paediatrica99(Suppl. 462), 47–120 (2010).
   PubMedGoogle Scholar
• Haber P, Patel M, Izurieta HS et al. Post licensure monitoring of intussusception after RotaTeq vaccination in the United States, 1 February 2006–2025 September 2007. Pediatrics121, 1206–1212 (2008).
   PubMed Web of Science ®Google Scholar
• O’Ryan M. The ever-changing landscape of rotavirus serotypes. Pediatr. Infect. Dis. J.28, S60–S62 (2009).
   PubMed Web of Science ®Google Scholar
• Santos N, Hoshino Y. Global distribution of rotavirus serotypes/genotypes and its implication for the development and implementation of an effective rotavirus vaccine. Rev. Med. Virol.15, 29–56 (2005).
   PubMed Web of Science ®Google Scholar
• Gentsch JR, Parashar UD, Glass RI. Impact of rotavirus vaccination: the importance of monitoring strains. Fut. Microbiol.4, 1231–1234 (2009).
   PubMed Web of Science ®Google Scholar
• Matthijnssens J, Bilcke J, Ciarlet M et al. Rotavirus disease and vaccination: impact on genotype diversity. Fut. Microbiol.4, 1303–1316 (2009).
   PubMed Web of Science ®Google Scholar
• Gurgel RQ, Cuevas LE, Vieira SC et al. Predominance of rotavirus P[4]G2 in a vaccinated population, Brazil. Emerg. Infect. Dis.13, 1571–1573 (2007).
   PubMed Web of Science ®Google Scholar
• Gurgel RQ, Correia JB, Cuevas LE. Effect of rotavirus vaccination on circulating virus strains. Lancet371, 301–302 (2008).
   PubMed Web of Science ®Google Scholar
• Nakagomi T, Cuevas LE, Gurgel RQ et al. Apparent extinction of non-G2 rotavirus strains from circulation in Recife, Brazil, after the introduction of rotavirus vaccine. Arch. Virol.153, 591–593 (2008).
   PubMed Web of Science ®Google Scholar
• Leite JP, Carvalho-Costa FA, Linhares AC. Group A rotavirus genotypes and the ongoing Brazilian experience – a review. Mem. Inst. Oswaldo Cruz103, 745–753 (2008).
   PubMed Web of Science ®Google Scholar
• Carvalho-Costa FA, Araújo IT, de Assis RMS et al. Rotavirus genotype distribution after vaccine introduction, Rio de Janeiro, Brazil. Emerg. Infect. Dis.15, 95–97 (2009).
   PubMed Web of Science ®Google Scholar
• Morillo SG, Luchs A, Cilli A et al. Characterization of rotavirus strains from day care centers: pre- and post-rotavirus vaccine era. J. Pediatr.86, 155–158 (2010).
   Web of Science ®Google Scholar
• Carvalho-Costa FA, Volotão EM, de Assis RMS et al. Laboratory-based rotavirus surveillance during the introduction of a vaccination program, Brazil, 2005–2009. Pediatr. Infect. Dis. J.30, S35–S41 (2011).
   PubMed Web of Science ®Google Scholar
• Rodrigues F, Iturriza M, Gonçalves G et al. Large variations in rotavirus (RV) disease and strain diversity during low-level vaccine use in Portugal. Presented at: 28th Annual Meeting of the European Society of Paediatric Infectious Diseases. Nice, France, 4–8 May 2010.
   Google Scholar
• Kirkwood CD, Boniface K, Barnes GL et al. Distribution of rotavirus genotypes after introduction of rotavirus vaccines, Rotarix and RotaTeq, into the national immunization program of Australia. Pediatr. Infect. Dis. J.30, S48–S53 (2011).
   PubMed Web of Science ®Google Scholar
• Linhares AC, Stupka JA, Ciapponi A et al. Burden and typing of rotavirus group A in Latin America and the Caribbean: systematic review and meta-analysis. Rev. Med. Virol. doi:10.1002/rmv.682 (2011) (Epub ahead of print).
   PubMedGoogle Scholar
• Linhares AC, Velázquez FR. Rotavirus P[4]G2 in a vaccinated population, Brazil. Emerg. Infect. Dis.14, 863–865 (2008).
   PubMed Web of Science ®Google Scholar
• Esteban LE, Rota LP, Gentsch JR et al. Molecular epidemiology of group A rotavirus in Buenos Aires, Argentina 2004–2007: reemergence of G2P[4] and emergence of G9P[8] strains. J. Med. Virol.82, 1083–1093 (2010).
   PubMed Web of Science ®Google Scholar
• Patel M, Pedreira C, De Oliveira LH et al. Association between pentavalent rotavirus vaccine and severe rotavirus diarrhea among children in Nicaragua. JAMA301, 2243–2251 (2009).
   PubMed Web of Science ®Google Scholar
• De Vos B, Han HH, Bouckenooghe A et al. Live attenuated rotavirus vaccine RIX4414, provides clinical protection in infants against rotavirus strains with and without shared G and P genotypes. Pediatr. Infect. Dis. J.28, 261–266 (2009).
   PubMed Web of Science ®Google Scholar
• Victoria JG, Wang C, Jones MS et al. Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus. J. Virol.84, 6033–6040 (2010).
   PubMed Web of Science ®Google Scholar
• Kuehn B. FDA: Benefits of rotavirus vaccination outweigh potential contamination risk. JAMA304, 30–31 (2010).
   PubMed Web of Science ®Google Scholar
• Baylis SA, Finsterbusch T, Bannert N, Blümel J, Mankertz A. Analysis of porcine circovirus type 1 detected in Rotarix vaccine. Vaccine29, 690–697 (2011).
   PubMed Web of Science ®Google Scholar
• Alejandro MB, Domingo JD, Martinón-Torres F. Circovirus and impact of temporary withdrawal of rotavirus vaccines in Spain. Hum. Vaccines7, 798–799 (2011).
   PubMed Web of Science ®Google Scholar
• Lopman BA, Curns AT, Yen C, Parashar UD. Infant rotavirus vaccination may provide indirect protection to older children and adults in the United States. J. Infect. Dis.204, 980–986 (2011).
   PubMed Web of Science ®Google Scholar